Conditions: Hypercholesterolemia Atherosclerosis Statin Adverse Reaction
Keywords: hyperlididemia LDL cholesterol statin intolerance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 269
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.

Detailed description:

Arms:
arm 1: bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided) arm 2: Matching placebo tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)

Interventions: intervention 1: Bempedoic acid intervention 2: Ezetimibe intervention 3: Placebo
Intervention descriptions: intervention 1: bempedoic acid 180 mg tablet intervention 2: ezetimibe 10 mg tablet intervention 3: matching placebo tablet

Protocol document:
Prot_000.pdf: 
Confidential 
Page 1 of 144 
1.
TITLE PAGE
BEMPEDOIC ACID 
1002-048 
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 
PARALLEL GROUP, MULTICENTER STUDY TO EVALUATE THE 
EFFICACY AND SAFETY OF BEMPEDOIC ACID (ETC-1002) 
180 MG/DAY AS ADD-ON TO EZETIMIBE THERAPY IN PATIENTS 
WITH ELEVATED LDL-C ON LOW DOSE OR LESS THAN LOW DOSE 
STATINS 
Study Phase: 
3 
IND Number: 
106654 
Indication: 
Treatment of hyperlipidemia 
Investigators: 
Approximately 75 sites in North America and Europe 
Sponsor: 
Esperion Therapeutics, Inc. 
3891 Ranchero Drive, Suite 150 
Ann Arbor, MI 48108 
Version 
Date 
Original Protocol 
22 September 2016 
Amendment 1: 
18 January2017 
Amendment 2: 
10 February 2017 
Confidentiality Statement 
THIS CONFIDENTIAL INFORMATION IS ABOUT AN INVESTIGATIONAL DRUG PROVIDED FOR THE EXCLUSIVE USE OF INVESTIGATORS OF 
THIS DRUG AND IS SUBJECT TO RECALL AT ANY TIME.  THE INFORMATION IN THIS DOCUMENT MAY NOT BE DISCLOSED UNLESS SUCH 
DISCLOSURE IS REQUIRED BY FEDERAL OR STATE LAW OR REGULATIONS.  SUBJECT TO THE FOREGOING, THIS INFORMATION MAY BE
DISCLOSED ONLY TO THOSE PERSONS INVOLVED IN THE STUDY WHO HAVE NEED TO KNOW, WITH THE OBLIGATION NOT TO FURTHER
DISSEMINATE THIS INFORMATION.  THESE RESTRICTIONS ON DISCLOSURE WILL APPLY EQUALLY TO ALL FUTURE ORAL OR WRITTEN 
INFORMATION, SUPPLIED TO YOU BY ESPERION THERAPEUTICS, INC., WHICH IS DESIGNATED AS “PRIVILEGED” OR “CONFIDENTIAL.”  
 
EudraCT:
 2016-004084-39
NCT number: NCT03001076
This NCT number has been applied to the document 
for purposes of  posting on clinicaltrials.gov


Bempedoic acid 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
Amendment 2, 10 February 2017 
Confidential 
Page 2 of 144 
2.
SYNOPSIS
Name of Sponsor/Company: Esperion Therapeutics, Inc. 
Title of Study: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the 
Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in 
Patients with Elevated LDL-C On Low Dose or Less Than Low Dose Statins 
Study Number: 1002-048 
Study Phase: 3 
Objectives: 
Primary: 
•
To assess the 12-week efficacy of bempedoic acid 180 mg/day versus placebo in decreasing
low-density lipoprotein cholesterol (LDL-C) when added to ezetimibe therapy in patients with
elevated LDL-C
Secondary: 
•
To evaluate the effect of 12-week treatment with bempedoic acid 180 mg/day versus placebo
when added to ezetimibe therapy on
− 
non-high-density lipoprotein cholesterol (non-HDL-C), 
− 
total cholesterol (TC), 
− 
apolipoprotein B (apoB), and 
− 
high-sensitivity C-reactive protein (hs-CRP) 
•
To evaluate the effect of 12-week treatment with bempedoic acid 180 mg/day versus placebo on
triglycerides (TG) and high-density lipoprotein cholesterol (HDL-C) when added to ezetimibe
•
To evaluate 12-week safety and tolerability of bempedoic acid 180 mg/day compared with
placebo when added to ezetimibe
Tertiary: 
•
To evaluate the effects of treatment with bempedoic acid 180 mg/day versus placebo when added
to ezetimibe therapy at 4 and 8 weeks on the following parameters:
− 
LDL-C 
− 
Non-HDL-C 
− 
TC 
− 
TG 
− 
HDL-C 


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Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 4 of 144 
Study Endpoints: 
Primary efficacy endpoint: 
• 
Percent change from baseline to Week 12 in LDL-C 
Secondary efficacy endpoints (specific to stepdown approach): 
1. Percent change from baseline to Week 12 in: 
a. non-HDL-C 
b. TC 
c. apoB 
d. hs-CRP 
Other secondary efficacy endpoints: 
2. Percent change from baseline to Week 12 in:  
a. TG 
b. HDL-C 
Tertiary efficacy endpoints: 
1. Assessments of percent change from baseline in lipid levels at the additional time points of Week 4 
(T2) and Week 8 (T3) in: 
a. LDL-C 
b. Non-HDL-C 
c. TC 
d. TG 
e. HDL-C 
2. Assessments of absolute change from baseline to Weeks 4, 8, and 12 in LDL-C 
Safety Endpoints: 
a. Subject incidence to treatment-emergent adverse events (TEAE) 
b. Safety laboratory values and vital signs 
c. Electrocardiogram (ECG) findings  
d. Cardiovascular event rates  
Study Population: 
Approximately 225 male and female patients. 
Inclusion Criteria:  
Each potential patient must satisfy all inclusion criteria to be enrolled in the study.  Selected inclusion 
criteria are listed below; all inclusion criteria are listed in the protocol body.  
1. Provision of written informed consent prior to any study-specific procedure 
2. Age ≥18 years or legal age of majority based on regional law, whichever is greater, at Week -5 
(Visit S1) 
3. Fasting (minimum of 10 hours) calculated LDL-C at Week -5 (Visit S1) as defined by ezetimibe 
use at screening: 
• 
For patients who have been taking ezetimibe 10 mg daily prior to Week -5 (Visit S1):  Fasting 
LDL-C ≥100 mg/dL (2.6 mmol/L) on stable background LMT (greater than or equal to 
4 weeks prior to screening)  
• 
For patients who have not been taking ezetimibe prior to Week -5 (Visit S1):  Fasting LDL-C 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 5 of 144 
≥120 mg/dL (3.1 mmol/L) on stable background LMT (greater than or equal to 4 weeks prior 
to screening).   
• 
All patients must have fasting LDL-C ≥70 mg/dL (1.8 mmol/L) at Week -1 (Visit S3). 
4. Currently receiving stable (greater than or equal to 4 weeks prior to screening) background statin dose 
that does not exceed low dose statin therapy.  
Note:  Patients must report attempting statin therapy and being unable to tolerate it due to an adverse 
safety effect that started or increased during statin therapy and resolved or improved when statin 
therapy was discontinued or the dose lowered. 
Low dose statin therapy is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, 
simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.   
Very low dose statin therapy is defined as an average daily dose of rosuvastatin <5 mg, atorvastatin 
<10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin <40 mg, or 
pitavastatin <2 mg.  
Patients on low or very low dose statin or unable to tolerate any statin at any dose are eligible.  
Patients may continue taking low or very low dose statin therapy throughout the study provided that it 
is stable (greater than or equal to 4 weeks) and well tolerated.  Patients unable to take any dose of 
statins are also eligible provided that statin therapy has been attempted. 
5. Men and nonpregnant, nonlactating women.  Women must be either 
• 
Naturally postmenopausal defined as ≥1 year without menses and  
− 
≥55 years, or  
− 
<55 years with follicle-stimulating hormone (FSH) ≥40.0 IU/L, or 
• 
Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation, or 
• 
Women of childbearing potential willing to use 2 acceptable methods of birth control (unless they 
have agreed to follow the definition of true abstinence).  The minimal requirement for adequate 
contraception should be started on Day 1, continuing during the study period and for at least 
30 days after the last dose of study drug.  Acceptable methods of birth control include: 
− 
oral, implantable, injectable, or topical birth control medications 
− 
placement of an intrauterine device with or without hormones 
− 
barrier methods including condom or occlusive cap with spermicidal foam or spermicidal 
jelly 
− 
vasectomized male partner who is the sole partner for this patient  
− 
True abstinence:  When this is in line with the preferred and usual lifestyle of the subject. 
(Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], 
declaration of abstinence for the duration of a trial, and withdrawal are not acceptable 
methods of contraception). 
Note:  There are no protocol-specific birth control requirements for men with partners who are able to 
become pregnant. 
Exclusion Criteria: 
Patients who meet any of the exclusion criteria are not eligible.  Selected exclusion criteria are listed 
below; all exclusion criteria are listed in the protocol body.  
1. Body mass index (BMI) >50 kg/m2 
2. Recent history of documented clinically significant cardiovascular disease including, but not limited 
to 
• 
Within 3 months of screening (Week -5 [Visit S1]) or between screening and randomization 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
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Page 6 of 144 
visits:  MI, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, 
stroke, transient ischemic attack, cerebrovascular event, symptomatic carotid artery disease, or 
symptomatic peripheral arterial disease.   
• 
Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) ≥160 mm Hg and 
diastolic blood pressure (DBP) ≥100 mm Hg after sitting quietly for 5 minutes.  Note: If the initial 
blood pressure (BP) values meet or exceed the specified level, an additional BP assessment may 
be completed.  If the systolic or the diastolic values continue to meet or exceed the threshold, the 
patient may not continue screening.  However, at the discretion of the investigator, the screening 
period may be extended up to 4 weeks to allow for a repeat qualifying BP assessment following 
adjustment of BP medication(s), provided that the patient has been on a stable dose of the BP 
medication for a minimum of 2 weeks prior to randomization and the repeat BP measurements do 
not meet the exclusion criteria 
• 
Within 3 months of screening [Week -5 (Visit S1)] or between screening and randomization 
visits, an arrhythmia requiring medical intervention.   
• 
Planned revascularization procedures 
• 
New York Heart Association (NYHA) Class IV heart failure 
3. Total fasting (minimum of 10 hours) TG ≥500 mg/dL (5.6 mmol/L) at Week -5 (S1)  
Note: TG may be repeated 1 time with the screening period extended up to 4 weeks.  For those 
patients who have a repeat TG, the repeat value will be used to determine eligibility.  
4. Hemoglobin A1C (HbA1C) ≥10% at Week -5 (Visit S1) 
5. Persistent poor adherence with study-supplied ezetimibe and/or single-blind, placebo study drug (ie, 
ingesting <80% of planned doses) or lack of tolerance to run-in medications assessed prior to 
randomization.  
6. Uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) >1.5 × the upper limit of 
normal (ULN) at Week -5 (Visit S1).  Patients stabilized on thyroid replacement therapy for at least 
6 weeks prior to randomization are allowed. 
7. Liver disease or dysfunction, including:  
• 
Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies 
(HCV-ABVivi) at Week -4 (Visit S2), or  
• 
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≥2 × ULN, and/or total 
bilirubin (TB) ≥2 × ULN at Week -5 (Visit S1).  If TB ≥1.2 × ULN, a reflex indirect 
(unconjugated) bilirubin will be obtained, and if consistent with Gilbert’s disease or if the patient 
has a history of Gilbert’s Disease, the patient may be enrolled in the study.  
Note: At the discretion of the investigator, a single repeat of ALT and/or AST may be completed 
prior to randomization.  For those patients who have a repeat ALT and/or AST, the repeat value 
will be used to determine eligibility.  Also, if test for hepatitis C antibody is positive, but optional 
reflexive test for hepatitis C ribonucleic acid (RNA) is negative, the patient can be enrolled.  
8. Renal dysfunction or glomerulonephritis, including estimated glomerular filtration rate (eGFR; using 
central laboratory determined Modification of Diet in Renal Disease [MDRD] formula) <30 mL/min 
at Week -5 (Visit S1).  Note, a single repeat qualifying eGFR, performed at the discretion of the 
investigator, is acceptable; 
9. Gastrointestinal conditions or procedures (including weight loss surgery; eg, Lap-Band® or gastric 
bypass) that may affect drug absorption;  
10. Hematologic or coagulation disorders or a hemoglobin (Hgb) level <10.0 g/dL at Week -5 (Visit S1); 
11. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 
5 years.  Nonmetastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ 


Bempedoic acid 
 
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Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
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Page 7 of 144 
are allowed; 
12. Unexplained creatine kinase (CK) >3 × ULN at any time prior to randomization (ie, not associated 
with recent trauma or physically strenuous activity).  Patients with an explained CK elevation must 
have single repeat CK ≤3 × ULN prior to randomization; 
13. History of drug or alcohol abuse within the last 2 years or reported current consumption of 
>14 alcoholic drinks/week, or any illicit drug use, history of amphetamine and derivatives abuse or 
cocaine abuse.  Subjects with amphetamine derivatives prescribed by and under the care of a health 
care practitioner can be enrolled after evaluation by the investigator;  
14. Blood donation, participation in a multiple blood draws, clinical study, major trauma, blood 
transfusion or surgery with or without blood loss within 30 days prior to randomization; 
15. Use of any experimental or investigational drugs within 30 days prior to screening.  Patients who have 
enrolled in a study of an experimental small interfering RNA (siRNA) inhibitor of PCSK9 are 
excluded; 
16. Previous enrollment in a bempedoic acid clinical study. 
17. Use of any of the following drugs prior to screening (Week -5, Visit S1) or a plan to use these drugs 
during the study as follows.  Screening can be extended for an additional 4 weeks if needed to adjust 
background therapy. 
• 
Within 2 weeks prior to screening 
− 
Cholestin or red yeast rice containing-products (also known as monascus purpureus extract) 
• 
Within 4 weeks prior to screening 
− 
Statin doses exceeding those defined as low dose.  Doses exceeding low dose statin therapy 
are defined as an average daily dose of rosuvastatin greater than 5 mg, atorvastatin greater 
than 10 mg, simvastatin greater than 10 mg, lovastatin greater than 20 mg, pravastatin greater 
than 40 mg, fluvastatin greater than 40 mg, or pitavastatin greater than 2 mg. 
• 
Within 6 weeks prior to screening for patients taking a statin 
- Gemfibrozil is not allowed in patients taking a statin as per co-administration instructions 
defined in the statin label 
• 
Within 3 months prior to screening:  
− 
Lomitapide or apheresis therapy  
− 
Probenecid or cyclosporine 
• 
Within 4 months prior to screening 
− 
PCSK9-inhibitors 
• 
Within 6 months prior to screening 
- Mipomersen 
• 
CETP inhibitors within the last 2 years to screening (Week -5, Visit S1) except for evaceptrapib 
within the last 3 months prior to screening (Week -5, Visit S1) 
18. Planned initiation of the following drugs during the clinical trial or changes to the following drugs 
prior to randomization (Day 1, Visit T1): 
• 
Hormone replacement (within 6 weeks prior to randomization) 
• 
Thyroid replacement (within 6 weeks prior to randomization) 
• 
Diabetes medications (within 4 weeks prior to randomization) 
• 
Obesity medication (within 4 weeks prior to randomization) 
19. New or planned dose changes of systemic corticosteroids.  


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 8 of 144 
Note:  Stable doses of systemic corticosteroids at screening are allowed (≥4 weeks from Visit S1). 
Topical steroids are allowed.  
20. An employee or contractor of the facility conducting the study, or a family member of the principal 
investigator, co-investigator, or any Sponsor personnel. 
21. Pregnant, breastfeeding, or intending to become pregnant within 30 days after study completion or 
last dose of study drug. 
22. Previous intolerance to ezetimibe. 
Investigational medicinal product(s) (IMP), dosage and mode of administration:  
• 
Bempedoic acid 180-mg tablets.  
• 
Matching placebo tablets 
• 
All IMP will be ingested once daily (once every 24 hours, at approximately the same time each 
day) with or without food. 
Non-investigational medicinal product(s) (NIMP), dosage and mode of administration: 
Background lipid-lowering therapy: 
• 
Study supplied ezetimibe 10 mg ingested once daily (every 24 hours, at approximately the same 
time each day when IMP is ingested) with or without food. 
• 
All other background LMT will be ingested as prescribed by a physician 
Criteria for evaluation: 
Lipid and Cardiometabolic Assessments: 
• 
Calculated LDL-C, HDL-C, non-HDL-C, TC, TG, and apoB.  
− 
If TG exceeds 400 mg/dL (4.5 mmol/L) or LDL-C is ≤50 mg/dL (1.3 mmol/L), direct 
measure of LDL-C will be conducted. 
• 
hs-CRP 
Safety Assessments: 
Adverse events and SAEs will be collected and reported.  Clinical endpoints will be collected and 
adjudicated by an independent CEC.  Clinical endpoints will also be reported as SAEs.  Other safety 
assessments will include clinical safety laboratories (including hematology, blood chemistry, coagulation, 
HbA1C, fasting glucose, and urinalysis), physical examination (PE) findings, vital signs, ECG readings, 
and weight. 
Clinical Laboratory Assessments: 
• 
Hematology:  Hematocrit (Hct), Hgb, mean corpuscular hemoglobin (MCH), mean corpuscular 
hemoglobin concentration (MCHC), mean corpuscular volume (MCV), platelet count, red blood 
cell (RBC) count, white blood cell (WBC) count with differential (absolute values only) 
• 
Urinalysis (Dipstick):  Clarity, bilirubin, color, glucose, ketones, leukocyte esterase, nitrite, occult 
blood, pH, protein, specific gravity, urobilinogen 
• 
Urinalysis (Microscopic):  Obtain centrally only if positive urine dipstick; bacteria, casts, crystals, 
epithelial cells, RBC, and WBC 
• 
Coagulation:  Prothrombin time (PT), International Normalized Ratio (INR) 
• 
Serum Chemistry (fasting):  Albumin (ALB), alkaline phosphatase (ALK-P), ALT (or serum 
glutamic pyruvic transaminase [SGPT]), AST (or serum glutamic oxaloacetic transaminase 
[SGOT]), blood urea nitrogen (BUN), calcium (Ca), carbon dioxide (CO2), chloride (Cl), 
creatinine, CK, glucose, lactate dehydrogenase (LDH), phosphorus, potassium (K), sodium (Na), 
total and direct bilirubin, total protein, uric acid  


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 9 of 144 
• 
HbA1C  
Other Screening Laboratories: 
HBsAg, hepatitis C virus (HCV), serum pregnancy test (only for females who are of childbearing 
potential), TSH 
Pharmacokinetic (PK) and other Biomarkers:  
• 
hs-CRP 
• 
Plasma PK concentrations will be collected prior to dose at Week 4 (Visit T2), Week 8 (Visit T3), 
and Week 12 (Visit T4) for use in further developing the population PK model. 
Safety and Monitoring:  
Monitoring and Management of Potential AEs and Adverse Events of Special Interest (AESI) 
Potential AEs: 
Based on findings in nonclinical models, potential AEs include reversible hypoglycemia and metabolic 
acidosis.  Potential cases of reversible hypoglycemia and metabolic acidosis will be identified by 
routine safety monitoring of AEs and clinical safety laboratories. 
Musculoskeletal Safety: 
Patients with CK abnormalities will also be reviewed for any other lab changes, such as creatinine, and 
any reported AEs or SAEs.  Musculoskeletal events will be identified and evaluated by routine safety 
monitoring of PE findings and AEs.  
Diabetes and Hyperglycemia: 
Cases of new onset of diabetes will be recorded as AEs.  Clinical laboratories, including HbA1C and 
fasting glucose, will also be evaluated across treatment groups during this study and all ongoing 
studies to identify potential cases of new onset of diabetes. 
Neurocognitive Events: 
Neurocognitive events will be identified and evaluated by routine safety monitoring of PE findings and 
AEs.  
Clinical Endpoints: 
Clinical endpoints will be monitored and adjudicated by an independent expert CEC for this study and 
other ongoing studies in the bempedoic acid program.  
Routine cardiovascular monitoring will include review of MACE and non-MACE cardiovascular AEs, 
SAEs, standard vital signs, and ECGs. 
Further details on occurrence and monitoring of AESI are available in the Investigator’s Brochure (IB). 
Statistical Methods: 
Sample Size 
The primary efficacy endpoint for this study is the percent change from baseline to Week 12 in LDL-C.   
The sample size of 150 randomized patients in the bempedoic acid 180 mg group and 75 randomized 
patients in the placebo group is expected to provide more than 95% power to detect a difference of 15% in 
the percent change from baseline to Week 12 in calculated LDL-C between the bempedoic acid treatment 
group and the placebo group.  This calculation is based on a 2-sided t-test at the 5% level of significance 
and a common standard deviation of 15%.  The sample size of 150 randomized patients in the bempedoic 
acid 180 mg group and 75 randomized patients in the placebo group gives a total study sample size 
of 225.  
Analysis Populations 
The Full Analysis Set (FAS), used for all of the efficacy analyses, is defined as all randomized patients.  
The FAS is also known as the intention-to-treat (ITT) set of patients.  Patients in the FAS will be included 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 10 of 144 
in their randomized treatment group, regardless of their actual treatment.  
The Safety Population (SP), used for all of the safety summaries, is defined as all randomized patients 
who received at least 1 dose of study medication.  Patients in the SP will be included in the treatment 
group that they actually received, regardless of their randomized treatment.  
Disposition and Baseline Characteristics 
Disposition, including reason for withdrawal from the study, will be summarized by treatment group.  
Demographic information and patient characteristics including, but not limited to, gender, race, age, and 
baseline vital signs will also be summarized by treatment group. 
Primary Efficacy Analysis 
The primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C.  Baseline is 
defined as the mean of the values from Week -1 (Visit S3) and predose Day 1/Week 0 (Visit T1).  The 
primary efficacy endpoint will be analyzed using analysis of covariance (ANCOVA), with treatment 
group as a factor and baseline LDL-C as a covariate.  The ANCOVA will be performed using the FAS, 
with patients included in their randomized treatment group regardless of the treatment they actually 
received.  Missing data will be imputed using multiple imputation method that accounts for treatment 
adherence via a pattern mixture model (PMM).  Imputed datasets will be analyzed using ANCOVA with 
treatment as a factor and baseline LDL-C as a covariate.  Approximately 200 imputed datasets will be 
created, with results from the analysis of each imputed dataset combined using Rubin’s method.  For final 
results, the least squares mean (LSM) and standard error (SE) will be provided for both treatment groups, 
along with the placebo-corrected LSM, its 95% confidence interval (CI), and associated p-value. 
Secondary and Tertiary Efficacy Analysis 
Absolute and percent change from baseline to specific time points for lipid parameters and hs-CRP will 
each be analyzed similarly using ANCOVA with treatment group as a factor and the relevant baseline as 
the covariate.  Baseline for non-HDL-C, HDL-C, TC, and TG are defined as the mean of the values from 
Week -1 (Visit S3) and predose Day 1/Week 0 (Visit T1), while baseline for apoB and hs-CRP is defined 
as the predose Day 1/Week 0 (Visit T1) value.  Each ANCOVA will be performed using the FAS, with 
patients included in their randomized treatment group regardless of the treatment they actually received.  
For each lipid parameter at each time point, the LSM and SE will be provided for both treatment groups, 
along with the placebo-corrected LSM, its 95% CI and associated p-value.  
For all continuous efficacy endpoints (percent change from baseline and absolute change from baseline in 
LDL-C, HDL-C, non-HDL-C, TC, TG, apoB, and hs-CRP; to Weeks 4, 8, and 12, as appropriate), the 
ANCOVA assumption of normality will be assessed.  If non-normality of the data is found at any time 
point for any parameter, either the data will be transformed so that it is normally distributed or a 
nonparametric test will be used instead of the planned ANCOVA. 
Safety Analyses 
The summarization of AEs will include only TEAEs.  TEAEs and SAEs will be summarized by system 
organ class (SOC), severity, and relationship to study drug for each treatment group.  These AE 
summaries will include cumulative incidence (percent of patients experiencing the AE) and patient-year 
adjusted incidence rates.  If appropriate, absolute and relative risk differences will be calculated using 
both cumulative incidence and incidence rates.  Deaths, withdrawal from study treatment due to AEs, and 
withdrawal from the study due to AEs will each be summarized by treatment group. 
Clinical safety laboratories, including hematology, blood chemistry, HbA1C, fasting glucose, and 
urinalysis; PE findings; vital signs; ECG readings; and weight will be summarized by the value and by 
change from baseline in the value (where appropriate) at each postbaseline time point. 
Hepatic Safety 
For liver-associated enzymes and TB, the number and percent of patients with abnormal values for ALT, 
AST, and TB will be summarized.  Hy’s criteria (≥3 × ULN for either ALT or AST, with accompanying 
TB >2 × ULN in the absence of other known causes (≥2 × ULN conjugated [direct] bilirubin will be used 


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in patients with Gilbert’s Disease), will also be applied to the data; any potential Hy’s law cases will be 
listed separately. 
Musculoskeletal Safety 
AEs of muscle related symptoms will be summarized by treatment group.  In addition, the number and 
percent of patients with abnormal CK values will be summarized.  
Diabetes and Hyperglycemia 
Cases of worsening and new onset of diabetes will be recorded as AEs and will be summarized using the 
appropriate SOC.  These events will be summarized by severity and relationship to study drug for each 
treatment group. 
Renal Safety 
Baseline eGFR and values of CK will be summarized by treatment group and by baseline eGFR 
categories.  Shift tables of eGFR category from baseline over the study, will be provided by treatment 
group.  Finally, muscle-related AEs will be summarized by treatment group and by baseline eGFR 
category. 
Neurocognitive Events 
Neurocognitive events will be identified and evaluated by routine safety monitoring of PE findings and 
AEs.  Summarization of neurocognitive events will occur using prespecified Medical Dictionary for 
Regulatory Activities (MedDRA) terms and will be performed by treatment group.  
Clinical endpoints 
Clinical endpoints using standardized definitions will be adjudicated by an independent blinded expert 
CEC for all ongoing Phase 3 studies in the bempedoic acid program.  Investigator-reported clinical 
endpoints and adjudicated clinical endpoints will be summarized by event type and treatment group.  
Additional details regarding the clinical endpoints and their definitions will be included in CEC Charter.  
PK and Other biomarkers 
PK plasma concentrations for ETC-1002 and its metabolite ESP15228 will be summarized at Week 4 
(Visit T2), Week 8 (Visit T3), and Week 12 (Visit T4). 
Clinical Labs: 
Hematology: 
Hct, Hgb, MCH, MCHC, MCV, platelet count, RBC count, WBC count with differential (absolute values 
only) 
Urinalysis (Dipstick): 
Appearance, bilirubin, color, glucose, ketones, leukocyte esterase, nitrite, occult blood, pH, protein, 
specific gravity, urobilinogen 
Urine pregnancy test (only for women of child bearing potential) 
Urinalysis (Microscopic): Obtained centrally only if positive urine dipstick 
Bacteria, casts, crystals, epithelial cells, RBC, WBC 
Coagulation: 
PT and INR  
Serum Chemistry: 
ALB, ALK-P, ALT (SGPT), AST (SGOT), TB , BUN, Ca, CO2, Cl, creatinine, CK, fasting glucose, 
LDH, phosphorus, K, Na, total and direct bilirubin, total protein, uric acid, HbA1C 


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Other Screening Labs: 
HBsAg, HCV, serum pregnancy test (only for women of childbearing potential), FSH (only to confirm 
postmenopausal status in appropriate females), TSH  
Basic Lipid Parameters: 
TC, calculated LDL-C (or measured if necessary), HDL-C, TG 
Special Lipid Parameters 
apoB 
Other Biomarkers and PK: 
hs-CRP, PK samples of ETC-1002 and ESP15228.  
 
 


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TABLE OF CONTENTS 
1. 
TITLE PAGE ................................................................................................................1 
2. 
SYNOPSIS ...................................................................................................................2 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS.............................19 
4. 
INTRODUCTION ......................................................................................................23 
4.1. 
Lipid-Regulating Drugs and Cardiovascular Disease .................................................23 
4.2. 
Background on Bempedoic Acid ................................................................................24 
4.2.1. 
Mechanism of Action .................................................................................................24 
4.2.2. 
Nonclinical Experience ...............................................................................................24 
4.2.3. 
Previous Human Experience .......................................................................................25 
4.2.4. 
Dose Selection ............................................................................................................26 
4.2.5. 
Background Therapy ..................................................................................................26 
4.2.6. 
Risk Benefit Summary ................................................................................................27 
5. 
TRIAL OBJECTIVES AND PURPOSE ....................................................................28 
5.1. 
Primary Objective .......................................................................................................28 
5.2. 
Secondary Objectives .................................................................................................28 
5.3. 
Tertiary Objectives .....................................................................................................28 
5.4. 
Study Endpoints ..........................................................................................................28 
5.4.1. 
Primary Efficacy Endpoint .........................................................................................28 
5.4.2. 
Secondary Efficacy Endpoints ....................................................................................29 
5.4.3. 
Tertiary Efficacy Endpoints ........................................................................................29 
5.4.4. 
Safety Endpoints .........................................................................................................29 
6. 
INVESTIGATIONAL PLAN .....................................................................................30 
6.1. 
Overall Study Design ..................................................................................................30 
6.2. 
Study Hypothesis ........................................................................................................30 
6.3. 
Study Duration and Period ..........................................................................................30 
6.4. 
End of Study ...............................................................................................................30 
6.5. 
Number of Patients .....................................................................................................30 


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6.6. 
Patient Identification Numbers ...................................................................................30 
6.6.1. 
Screening and Placebo Run-in Period ........................................................................31 
6.6.2. 
Randomization and Treatment Periods .......................................................................31 
7. 
SELECTION AND WITHDRAWAL OF PATIENTS ..............................................32 
7.1. 
Subject Inclusion Criteria ...........................................................................................32 
7.2. 
Subject Exclusion Criteria ..........................................................................................33 
7.3. 
Patient Lifestyle and Dietary Guidelines ....................................................................36 
7.4. 
Investigator/Sponsor Suspension or Termination of Patient Enrollment ...................36 
8. 
TREATMENT OF PATIENTS ..................................................................................37 
8.1. 
IMP Dosage and Mode of Administration ..................................................................37 
8.2. 
Description of Investigational Medicinal Product ......................................................37 
8.3. 
Non-investigational Medicine Products Dose and Description ..................................37 
8.3.1. 
Ezetimibe ....................................................................................................................37 
8.3.2. 
Background Lipid-Lowering Therapy ........................................................................37 
8.4. 
Concomitant Medications ...........................................................................................38 
8.4.1. 
Lipid-Regulating Medications and Supplements........................................................38 
8.4.2. 
Prohibited Medications ...............................................................................................38 
8.4.3. 
Allowable Medications ...............................................................................................39 
8.5. 
Treatment Compliance ................................................................................................39 
8.5.1. 
Screening Compliance ................................................................................................39 
8.5.2. 
Placebo Run-in and Treatment Period Adherence ......................................................39 
8.6. 
Blinding ......................................................................................................................39 
8.7. 
Overdose .....................................................................................................................41 
9. 
INVESTIGATIONAL MEDICINAL PRODUCT .....................................................42 
9.1. 
Investigational Medicinal Product Supply and Control ..............................................42 
9.2. 
Administration of Investigational Medicinal Product ................................................42 
9.3. 
Investigational Medicinal Product Accountability .....................................................43 
9.4. 
Investigational Medicinal Product Handling and Disposal ........................................43 


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10. 
STUDY PROCEDURES ............................................................................................44 
10.1. 
Informed Consent .......................................................................................................44 
10.2. 
Procedures and Schedule of Assessments ..................................................................44 
10.2.1. 
Screening Week -5 (Visit S1; Day -35 to ± 7 days) ...................................................44 
10.2.2. 
Placebo and Ezetimibe Run in Week -4 (Visit S2; Day -28 to ±3 days) ....................45 
10.2.3. 
Placebo and Ezetimibe Run-in Week -1 (Visit S3; Day -7 to ±3 days) .....................45 
10.2.4. 
Treatment Week 0 (Visit T1; Day 1) ..........................................................................46 
10.2.5. 
Treatment Week 4 (Visit T2; Day 29 ±3 days) ..........................................................47 
10.2.6. 
Treatment Week 8 (Visit T3; Day 57 ±3 days) ..........................................................47 
10.2.7. 
Treatment Week 12/EOS (Visit T4; Day 85 ±3 days) ................................................48 
10.3. 
Subject Withdrawal Criteria .......................................................................................49 
10.3.1. 
Early Withdrawal from the Study ...............................................................................49 
10.3.2. 
Procedures for Early Withdrawal ...............................................................................50 
11. 
ASSESSMENT OF SAFETY .....................................................................................51 
11.1. 
Safety Parameters .......................................................................................................51 
11.1.1. 
Demographic/Medical History ...................................................................................51 
11.1.2. 
Vital Signs ..................................................................................................................51 
11.1.3. 
Weight, Height, and Body Mass Index .......................................................................51 
11.1.4. 
Physical Examination .................................................................................................51 
11.1.5. 
Electrocardiogram .......................................................................................................52 
11.1.5.1. 
Monitoring and Management of Abnormal Electrocardiograms ................................52 
11.1.6. 
Clinical Laboratory Tests ...........................................................................................52 
11.1.6.1. 
Laboratory Parameters (Safety) ..................................................................................52 
11.1.6.2. 
Sample Collection, Storage, and Shipping .................................................................54 
11.1.6.3. 
General Monitoring and Management of Abnormal Clinical Labs ............................54 
11.1.6.4. 
Pharmacokinetic Assessments ....................................................................................58 
11.1.6.5. 
Collection and Assessment of Pharmacokinetic Samples ..........................................59 
11.1.6.6. 
Shipment of Pharmacokinetic Samples ......................................................................59 


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11.1.6.7. 
Total Blood Volume of Clinical Laboratory and Pharmacokinetic Samples .............59 
11.2. 
Adverse and Serious Adverse Events .........................................................................59 
11.2.1. 
Definition of Adverse Events .....................................................................................59 
11.2.2. 
Adverse Drug Reaction ...............................................................................................60 
11.2.3. 
Reporting ....................................................................................................................60 
11.2.4. 
Severity .......................................................................................................................61 
11.2.5. 
Relationship ................................................................................................................61 
11.2.6. 
Monitoring and Follow-up of Adverse Events ...........................................................62 
11.2.7. 
Treatment-Emergent Adverse Events .........................................................................62 
11.2.7.1. 
Definition of Serious Adverse Event ..........................................................................62 
11.2.7.2. 
Definition of Serious Adverse Events or Outcomes not Qualifying as Serious 
Adverse Events ...........................................................................................................63 
11.2.7.3. 
Clinical Laboratory Assessments as Adverse Events and Serious Adverse 
Events .........................................................................................................................63 
11.3. 
Reporting Serious Adverse Events .............................................................................63 
11.3.1. 
Reporting of Serious Adverse Events to Regulatory Authorities ...............................64 
11.3.2. 
Reporting of Patient Death .........................................................................................64 
11.3.3. 
Reports of Pregnancy ..................................................................................................64 
11.4. 
Adverse Events of Special Interest .............................................................................65 
11.5. 
Data Monitoring Committee .......................................................................................67 
11.6. 
Clinical Event Committee ...........................................................................................67 
11.7. 
Assessment of Lipid Endpoints ..................................................................................68 
11.7.1. 
Lipid Parameters .........................................................................................................68 
11.7.2. 
Clinical Safety Laboratory Tests ................................................................................68 
12. 
STATISTICS ..............................................................................................................69 
12.1. 
General Considerations ...............................................................................................69 
12.2. 
Determination of Sample Size ....................................................................................69 
12.3. 
Analysis Populations ..................................................................................................69 


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12.4. 
Disposition, Demographics, and Baseline Characteristics .........................................69 
12.5. 
Primary Efficacy Analysis ..........................................................................................69 
12.6. 
Secondary and Tertiary Efficacy Endpoints ...............................................................70 
12.7. 
Safety Endpoints .........................................................................................................71 
12.7.1. 
Hepatic Safety .............................................................................................................71 
12.7.2. 
Musculoskeletal Safety ...............................................................................................71 
12.7.3. 
Diabetes and Hyperglycemia ......................................................................................71 
12.7.4. 
Renal Safety ................................................................................................................71 
12.7.5. 
Neurocognitive Events ................................................................................................72 
12.7.6. 
Clinical endpoints .......................................................................................................72 
13. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS.........................................73 
13.1. 
Audits and Inspections ................................................................................................73 
14. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................75 
15. 
ETHICS ......................................................................................................................76 
15.1. 
Institutional Review Board/Independent Ethics Committee Approval ......................76 
15.2. 
Ethical Conduct of Study ............................................................................................76 
15.3. 
Written Informed Consent ..........................................................................................77 
15.4. 
Patient Confidentiality ................................................................................................77 
16. 
DATA HANDLING AND RECORDKEEPING .......................................................78 
16.1. 
Inspection of Records .................................................................................................78 
16.2. 
Retention of Records ..................................................................................................78 
16.3. 
Case Report Forms and Study Records ......................................................................78 
17. 
ADMINISTRATIVE CONSIDERATIONS ..............................................................80 
17.1. 
Investigators ................................................................................................................80 
17.2. 
Study Administrative Structure ..................................................................................81 
17.3. 
Amendments ...............................................................................................................81 
17.4. 
Financial Disclosure ...................................................................................................81 
18. 
PUBLICATION AND DISCLOSURE POLICY .......................................................83 


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19. 
LIST OF REFERENCES ............................................................................................84 
20. 
APPENDICES ............................................................................................................86 
APPENDIX 1. SCHEDULE OF EVENTS (PATIENT VISIT SCHEDULE) ...........................87 
APPENDIX 2. SPONSOR’S SIGNATURE ...............................................................................89 
APPENDIX 3. INVESTIGATOR’S SIGNATURE....................................................................93 
APPENDIX 4. SUMMARY OF CHANGES AMENDMENT 1 ...............................................94 
APPENDIX 5. SUMMARY OF CHANGES AMENDMENT 2 ...............................................99 
 
LIST OF TABLES 
Table 1: 
Abbreviations and Specialist Terms ...........................................................................19 
Table 2: 
Investigational Medicinal Products ............................................................................37 
Table 3: 
Clinical Laboratory Parameters (Safety) ....................................................................53 
Table 4: 
Clinical Laboratory Parameters (Lipids) and Cardiometabolic Biomarkers ..............68 
 
 


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3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
The following abbreviations and specialist terms are used in this study protocol. 
Table 1: 
Abbreviations and Specialist Terms  
Abbreviation or Specialist Term 
Explanation 
ACL 
adenosine triphosphate-citrate lyase 
ACS 
acyl-CoA synthetase 
ADR 
adverse drug reaction 
AE 
adverse event 
AESI 
adverse events of special interest 
ALB 
albumin 
ALK-P 
alkaline phosphatase 
ALT 
alanine aminotransferase 
ANCOVA 
analysis of covariance 
apoB 
apolipoprotein B 
ASCVD 
atherosclerotic cardiovascular diseases 
AST 
aspartate aminotransferase 
ATP 
adenosine triphosphate 
AUC0-24 
area under the curve during 24 hours 
BMI 
body mass index 
BP 
blood pressure 
BUN 
blood urea nitrogen 
Ca 
calcium 
CEC 
Clinical Event Committee 
CETP-I 
Cholesteryl ester transfer protein inhibitor 
CFR 
Code of Federal Regulations 
CHD 
coronary heart disease 
CI 
confidence interval 
CK 
creatine kinase 
Cl 
chloride 
Cmax 
time to peak maximum concentrations 
CMV 
cytomegalovirus 
CNS 
central nervous system 
CoA 
acetyl-coenzyme A 
CO2 
carbon dioxide 
CRO 
contract research organization 


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Table 1: 
Abbreviations and Specialist Terms  
Abbreviation or Specialist Term 
Explanation 
CV 
cardiovascular 
CYP 
cytochrome P450 
DBP 
diastolic blood pressure 
DMC 
Data Monitoring Committee 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EMA 
European Medicines Agency 
eGFR 
estimated glomerular filtration rate 
EOS 
end of study 
ETC-1002-CoA 
ETC-1002-coenzyme A 
EU 
European Union 
FAS 
full analysis set 
FDA 
U.S. Food and Drug Administration 
FPFV 
first patient first visit 
FSH 
follicle-stimulating hormone 
GCP 
good clinical practice 
GI 
gastrointestinal 
HbA1C 
glycosylated hemoglobin, Type A1C 
HBsAg 
hepatitis B surface antigen 
Hct 
hematocrit 
HCV 
hepatitis C virus 
HCV-AB 
hepatitis C antibodies 
HDL-C 
high-density lipoprotein cholesterol 
Hgb 
hemoglobin 
HMG-CoA 
3-hydroxy-3-methylglutaryl-coenzyme A 
hs-CRP 
high-sensitivity C-reactive protein 
IB 
investigator’s brochure 
ICD 
informed consent document 
ICH 
International Conference on Harmonisation 
IEC 
independent ethics committee 
IMP 
investigational medicinal product 
IND 
Investigational New Drug Application 
INR 
international normalized ratio 
IRB 
institutional review board 
ITT 
intention-to-treat 


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Table 1: 
Abbreviations and Specialist Terms  
Abbreviation or Specialist Term 
Explanation 
IWRS 
interactive web response system 
K 
potassium 
LDH 
lactate dehydrogenase 
LDL-C 
low-density lipoprotein cholesterol 
LDLR 
low-density lipoprotein receptor 
LFT 
liver function test 
LPLV 
last patient last visit 
LMT 
lipid-modifying therapy 
LS 
least square 
LSM 
least square mean 
MACE 
major adverse cardiac event 
MCH 
mean corpuscular hemoglobin 
MCHC 
mean corpuscular hemoglobin concentration 
MCV 
mean corpuscular volume 
MDRD 
modification of diet in renal disease 
MED ID 
medication identification 
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
myocardial infarction 
MRI 
magnetic resonance imaging 
Na 
sodium 
NIMP 
non-investigational medicinal product(s) 
NLA 
National Lipid Association 
NOAEL 
No-observed-adverse-effect level 
non-HDL-C 
non-high-density lipoprotein cholesterol 
NYHA 
New York Heart Association 
PCSK9 
proprotein convertase subtilisin/kexin type 9 
PE 
physical exam 
PK 
pharmacokinetic(s) 
PG 
pharmacogenomic 
PMM 
pattern mixed model 
PT 
prothrombin time 
RBC 
red blood cell 
RNA 
ribonucleic acid 
SAE 
serious adverse event 
SAP 
statistical analysis plan 


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Table 1: 
Abbreviations and Specialist Terms  
Abbreviation or Specialist Term 
Explanation 
SBP 
systolic blood pressure 
SE 
standard error 
SGOT 
serum glutamic oxaloacetic transaminase 
SGPT 
serum glutamic pyruvic transaminase 
siRNA 
small interfering ribonucleic acid 
SOC 
system organ class 
SOP 
standard operating procedures 
SP 
safety population 
SUSARS 
suspected and unexpected serious adverse reactions 
t½  
terminal elimination half-live 
T2DM 
type 2 diabetes mellitus 
TB 
total bilirubin 
TC 
total cholesterol 
TEAE 
treatment-emergent adverse event 
TG 
triglycerides 
TSH 
thyroid-stimulating hormone 
TQT 
thorough QT/QTc 
ULN 
upper limit of normal 
US 
United States 
WBC 
white blood cell 
WHO 
World Health Organization 
 


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4. 
INTRODUCTION 
4.1. 
Lipid-Regulating Drugs and Cardiovascular Disease 
Bempedoic acid (ETC-1002) is an inhibitor of adenosine triphosphate-citrate lyase (ACL) 
(adenosine triphosphate [ATP] citrate lyase), an enzyme upstream of 3-hydroxy-3-methylglutaryl 
coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway.  It is an oral, first-
in-class small molecule designed to lower low-density lipoprotein cholesterol (LDL-C) levels in 
patients with high cardiovascular (CV) risk unable to meet their treatment goals with currently 
available lipid-lowering therapies. 
The target population for this study includes patients with elevated LDL-C who are only able to 
tolerate low dose or less than low dose of statins (including those not taking a statin due to 
inability to tolerate a statin) or in combination with other lipid-modifying therapies (in some 
cases also includes ezetimibe) and who require additional LDL-C lowering. 
Elevated LDL-C is a major modifiable risk factor for the development of atherosclerosis and 
atherosclerotic cardiovascular diseases (ASCVD) [1].  Despite aggressive interventional and 
pharmacologic therapies, CV disease is the number 1 cause of death globally [2].  An estimated 
17.5 million people died from CV diseases in 2012, representing 31% of all deaths worldwide.  
Of these deaths, an estimated 7.4 million were due to coronary heart disease (CHD) and 
6.7 million were due to stroke [2].  Cardiovascular disease remains the leading cause of death 
among Americans, Europeans, and around the world.  The Global Burden of Disease study 
estimated that 29.6% of all deaths (approximately 15.6 million deaths) were caused by CV disease 
in 2010, more than all communicable, maternal, neonatal, and nutritional disorders combined, 
and double the number of deaths caused by cancers [3].  In the United States (US), based on 
2011 death rate data, more than 2150 Americans die from CV diseases daily, an average of 
1 death every 40 seconds.  Approximately 155,000 Americans dying from CV disease are less 
than 65 years of age.  In 2011, 34% of deaths due to CV disease occurred prior to the age of 
75 years, less than the current 78.7-year average life expectancy [4].  
LDL-C is largely accepted as a valid surrogate endpoint of CV events by clinicians and 
regulatory authorities [5].  Long-term elevations in LDL-C lead to progressive accumulation of 
atherosclerotic lesions in the walls of arteries that require long-term management.  While 
lifestyle changes are the primary intervention, these measures rarely decrease plasma LDL-C by 
>15%.  Evidence supporting LDL-C as a therapeutic target and surrogate for CV outcomes 
comes from interventional studies with LDL-C-lowering therapies, epidemiological studies, 
genetic variants (both gain of function and loss of function).  Large randomized clinical studies 
aimed at lowering LDL-C show a consistent log-linear relationship between LDL-C reduction 
and CV risk reduction, independent of the way LDL-C lowering was achieved based on 
mechanism of action [6,7,8,9].  A published patient-level meta-analysis including 26 trials and 
more than 160,000 participants, showed a consistent relationship between LDL-C reduction and 
CV outcomes [7].  This analysis showed that a 1 mmol/L reduction in LDL-C was associated 
with a 22% reduction in the 5-year incidence of major coronary events, revascularizations, and 
ischemic strokes.  Intensive statin therapy relative to low/moderate intensity statin treatment 
produces greater benefit in patients at high CV risk [10].   


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Unfortunately, some patients with elevated LDL-C are unable to take high intensity statins due to 
dosing limits based on comorbidities, contraindications, and/or tolerance [11].  Nonstatin 
therapies may provide additional lowering of CV risk as demonstrated in the IMPROVE-IT trial 
which added ezetimibe to statin therapy [12].  The addition of bempedoic acid to ezetimibe and 
low intensity statin therapy may offer additional lowering of LDL-C with associated lowering of 
CV risk.  Bempedoic acid has been well tolerated to date and Phase 2 data demonstrate 
significant LDL-C lowering, prompting further evaluation in Phase 3 clinical studies.  
4.2. 
Background on Bempedoic Acid 
4.2.1. 
Mechanism of Action 
Bempedoic acid is a first-in-class small molecule inhibitor of ACL, an enzyme upstream of 
HMG-CoA in the cholesterol biosynthesis pathway.  Bempedoic acid is a prodrug that requires 
activation in liver to ETC-1002-coenzyme A (ETC-1002-CoA), which mediates competitive 
inhibition of ACL.  Inhibition of ACL by ETC-1002-CoA decreases cholesterol synthesis in the 
liver leading to increased low-density lipoprotein receptor (LDLR) expression and LDL particle 
clearance from the blood.  Therefore, inhibition of ACL by ETC-1002-CoA decreases LDL-C 
via the same pathway as HMG-CoA reductase inhibition by statins. 
An important differentiating feature of bempedoic acid is that, unlike statins, it does not inhibit 
cholesterol synthesis in skeletal muscle.  The enzyme required to convert bempedoic acid to 
ETC-1002-CoA is not present in skeletal muscle.  Therefore, bempedoic acid is not anticipated 
to mediate the adverse effects associated with inhibition of biological intermediates within the 
cholesterol biosynthesis pathway in skeletal muscle; however, the safety of bempedoic acid and 
its metabolites regarding human skeletal muscle is not yet established. 
4.2.2. 
Nonclinical Experience 
 
 
 
 
 
 
 
 
 
 
  


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4.2.3. 
Previous Human Experience 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 


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4.2.4. 
Dose Selection 
 
 
 
 
 
 
 
4.2.5. 
Background Therapy 
In this study, bempedoic acid is being evaluated as an add-on therapy to ezetimibe for decreasing 
LDL-C in addition to background low dose or less than low dose statin therapy in patients with 
elevated LDL-C who require additional LDL-C lowering. 


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4.2.6. 
Risk Benefit Summary 
To date, the nonclinical and clinical data indicate that bempedoic acid has a favorable risk-
benefit profile.  The ability of bempedoic acid to achieve clinically meaningful LDL-C-lowering 
responses while demonstrating a favorable tolerability profile in a variety of patient populations 
supports continued development of bempedoic acid, an oral ACL inhibitor, in the Phase 3 
program. 


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5. 
TRIAL OBJECTIVES AND PURPOSE 
5.1. 
Primary Objective 
The primary objective of this study is  
• To assess the 12-week efficacy of bempedoic acid 180 mg/day versus placebo in 
decreasing LDL-C when added to ezetimibe therapy in patients with elevated LDL-C 
5.2. 
Secondary Objectives 
The secondary objectives of this study are 
• To evaluate the effect of 12-week treatment with bempedoic acid 180 mg/day versus 
placebo when added to ezetimibe therapy on  
− non-high-density lipoprotein cholesterol (non-HDL-C), 
− total cholesterol (TC), 
− apolipoprotein B (apoB), and  
− high-sensitivity C-reactive protein (hs-CRP)  
• To evaluate the effect of 12-week treatment with bempedoic acid 180 mg/day versus 
placebo on TG and HDL-C when added to ezetimibe 
• To evaluate 12-week safety and tolerability of bempedoic acid 180 mg/day compared 
with placebo when added to ezetimibe 
5.3. 
Tertiary Objectives 
The tertiary objectives of this study are 
• To evaluate the effects of treatment with bempedoic acid 180 mg/day versus placebo 
when added to ezetimibe therapy at Weeks 4 and 8 on: 
− LDL-C 
− Non-HDL-C 
− TC 
− TG 
− HDL-C 
5.4. 
Study Endpoints 
5.4.1. 
Primary Efficacy Endpoint 
The primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C. 


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5.4.2. 
Secondary Efficacy Endpoints 
Secondary efficacy endpoints (specific to stepdown approach [Section 12.6]) are 
1. Percent change from baseline to Week 12 in 
a. non-HDL-C 
b. TC 
c. apoB 
d. hs-CRP 
Other secondary efficacy endpoints are 
2. Percent change from baseline to Week 12 in  
a. TG 
b. HDL-C 
5.4.3. 
Tertiary Efficacy Endpoints 
Tertiary endpoints include assessments of percent change and absolute change from baseline in 
lipid levels at the additional time points of Week 4 (T2) and Week 8 (T3). 
1. Percent change from baseline to Weeks 4 and 8 in  
a. LDL-C 
b. Non-HDL-C 
c. TC 
d. TG 
e. HDL-C 
2. Absolute change from baseline to Weeks 4, 8, and 12 in LDL-C. 
5.4.4. 
Safety Endpoints 
a. Subject incidence to TEAE 
b. Safety laboratory values and vital signs 
c. ECG findings 
d. Cardiovascular event rates 


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6. 
INVESTIGATIONAL PLAN 
6.1. 
Overall Study Design 
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study evaluating 
the efficacy and safety of bempedoic acid as an add-on therapy to ezetimibe in patients with 
elevated LDL-C.  
Screening Week -5 (Visit S1) will begin approximately 5 weeks prior to randomization, but can 
be extended for an additional 4 weeks, if needed, to adjust background medical therapy or for 
other reasons as specified in the protocol.  Eligible patients will return to the clinical site at 
Week -4 (Visit S2) to begin treatment with study supplied ezetimibe 10 mg and single-blind 
placebo.  Patients having their own supply of ezetimibe will switch to study-supplied ezetimibe 
at this visit.  
6.2. 
Study Hypothesis 
The study will assess the 12-week efficacy of bempedoic acid as an add-on therapy to ezetimibe 
in decreasing LDL-C versus placebo.  The treatment duration of 12 weeks and study population 
of 225 patients will provide data on the lipid profile, safety, and tolerability of bempedoic acid in 
patients with elevated LDL-C who have a need for additional lipid-lowering therapy.  
6.3. 
Study Duration and Period 
The expected total duration of study participation for each randomized patient is approximately 
17 weeks.  The study will consist of an approximately 1-week screening period, a 4-week 
placebo run-in period, and a 12-week of treatment period. 
6.4. 
End of Study 
The study will end when the last randomized patient completes the Week 12 visit.  The estimated 
overall duration of the study (first patient first visit [FPFV] to last patient last visit [LPLV]) is 
approximately 11 months. 
6.5. 
Number of Patients 
Approximately 225 eligible patients will be randomized 2:1 on Day 1 (Visit T1) to receive either 
bempedoic acid 180 mg (N = 150) or placebo (N = 75) for 12 weeks. 
6.6. 
Patient Identification Numbers 
A unique patient identification number will be assigned to identify each patient throughout the 
study and will be entered on all documentation.  If a patient is not eligible to receive treatment, 
or if a patient discontinues from the study, their patient identification number cannot be assigned 
to another patient.  
Patient identification numbers will be assigned sequentially by interactive web response system 
(IWRS) at the time of informed consent during the screening module transaction.  


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6.6.1. 
Screening and Placebo Run-in Period 
Screening will occur approximately 5 weeks prior to Day 1 (Visit T1) when the patient’s 
eligibility will be evaluated.  Eligible patients who are taking concomitant medications must be 
on stable regimens as defined in Section 7.1.  At the investigator’s discretion, screening may be 
extended for an additional 4 weeks, if needed, to adjust background medical therapy or for other 
reasons as specified in the protocol.  Eligible patients will return to the clinical site at Week -4 
(Visit S2) to initiate administration of open label ezetimibe and single-blind placebo.  Eligible 
patients will return at Week -1 (Visit S3) for basic fasting lipids assessments and an assessment 
of tolerability and study drug adherence (see Section 7 for eligibility criteria).  Patients who are 
deemed not eligible for randomization at any point during screening will be notified by clinical 
site personnel regarding their eligibility status and considered screen failures.  As necessary, for 
reasons of safety if a patient begins the run-in period but fails screening prior to randomization, 
the patient may be asked to return to the clinical site for further evaluation and follow-up of AEs. 
6.6.2. 
Randomization and Treatment Periods 
For patients who satisfy all entry criteria and complete the 1-week screening period and 4-week 
run-in period, randomization to a treatment group will occur via IWRS at Week 0 (Visit T1).  
Approximately 225 patients will be randomized in a ratio of 2:1 to receive 1 of the 2 following 
treatments in a double-blind fashion: 
• Bempedoic acid 180-mg tablet 
• Matching placebo tablet 


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7. 
SELECTION AND WITHDRAWAL OF PATIENTS 
7.1. 
Subject Inclusion Criteria 
Each potential patient must satisfy all of the following criteria to be enrolled in the study. 
1. Provision of written informed consent prior to any study-specific procedure 
2. Age ≥18 years or legal age of majority based on regional law, whichever is greater, at 
Week -5 (Visit S1) 
3. Fasting (minimum of 10 hours) calculated LDL-C at Week -5 (Visit S1) as defined by 
ezetimibe use at screening: 
• For patients who have been taking ezetimibe 10 mg daily prior to Week -5 (Visit S1):  
Fasting LDL-C ≥100 mg/dL (2.6 mmol/L) on stable background lipid-modifying 
therapy (LMT; greater than or equal to 4 weeks prior to screening) 
• For patients who have not been taking ezetimibe Week -5 (Visit S1):  Fasting LDL-C 
≥120 mg/dL (3.1 mmol/L) on stable background LMT (greater than or equal to 
4 weeks prior to screening). 
• All patients must have fasting LDL-C ≥70 mg/dL (1.8 mmol/L) at Week -1 (Visit S3) 
4. Currently receiving stable (greater than or equal to 4 weeks prior to screening) 
background statin dose that does not exceed low dose statin therapy.  Patients must report 
attempting statin therapy and being unable to tolerate it due to an adverse safety effect 
that started or increased during statin therapy and resolved or improved when statin 
therapy was discontinued or the dose lowered. 
Low dose statin therapy is defined as an average daily dose of rosuvastatin 5 mg, 
atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 
40 mg, or pitavastatin 2 mg.   
Very low dose statin therapy is defined as an average daily dose of rosuvastatin <5 mg, 
atorvastatin <10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, 
fluvastatin <40 mg, or pitavastatin <2 mg.  
Patients on low or very low dose statin or unable to tolerate any statin at any dose are 
eligible.  Patients may continue taking low or very low dose statin therapy throughout the 
study provided that it is stable (greater than or equal to 4 weeks) and well tolerated.  
Patients unable to take any dose of statins are also eligible provided that statin therapy 
has been attempted as described above.  
5. Men and nonpregnant, nonlactating women.  Women must be either 
• Naturally postmenopausal defined as ≥1 year without menses and  
− ≥55 years, or  
− <55 years with follicle-stimulating hormone (FSH) ≥40.0 IU/L, or 
• Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal 
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• Women of childbearing potential willing to use 2 acceptable methods of birth control 
(unless they have agreed to follow the definition of true abstinence).  The minimal 
requirement for adequate contraception should be started on Day 1, continuing during 
the study period and for at least 30 days after the last dose of study drug.  Acceptable 
methods of birth control include: 
− oral, implantable, injectable, or topical birth control medications 
− placement of an intrauterine device with or without hormones 
− barrier methods including condom or occlusive cap with spermicidal foam or 
spermicidal jelly 
− vasectomized male partner who is the sole partner for this patient  
− True abstinence:  When this is in line with the preferred and usual lifestyle of the 
subject.  (Periodic abstinence [eg, calendar, ovulation, symptothermal, 
postovulation methods], declaration of abstinence for the duration of a trial, and 
withdrawal are not acceptable methods of contraception). 
Note:  There are no protocol-specific birth control requirements for men with partners 
who are able to become pregnant. 
7.2. 
Subject Exclusion Criteria 
Patients who meet any of the following criteria are not eligible: 
1. Body mass index (BMI) >50 kg/m2 
2. Recent history of documented clinically significant cardiovascular disease including, but 
not limited to 
• Within 3 months of screening (Week -5 [Visit S1]) or between screening and 
randomization, myocardial infarction, severe or unstable angina pectoris, coronary 
angioplasty, coronary artery bypass graft, stroke, transient ischemic attack, 
cerebrovascular event, symptomatic carotid artery disease, or symptomatic peripheral 
arterial disease  
• Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) ≥160 mm 
Hg and diastolic blood pressure (DBP) ≥100 mm Hg after sitting quietly for 
5 minutes.  Note: If the initial blood pressure (BP) values meet or exceed the 
specified level, an additional BP assessment may be completed.  If the systolic or the 
diastolic values continue to meet or exceed the threshold, the patient may not 
continue screening.  However, at the discretion of the investigator, the screening 
period may be extended up to 4 weeks to allow for a repeat qualifying BP assessment 
following adjustment of BP medication(s), provided that the patient has been on a 
stable dose of the BP medication for a minimum of 2 weeks prior to randomization 
and the repeat BP measurements do not meet the exclusion criteria 
• Within 3 months of screening (Week -5 [Visit S1]) or between screening and 
randomization visits, arrhythmia requiring medical intervention.   


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• Planned revascularization procedures  
• New York Heart Association (NYHA) Class IV heart failure 
3. Total fasting (minimum of 10 hours) TG ≥500 mg/dL (5.6 mmol/L) at Week -5 (Visit S1)  
Note:  TG may be repeated 1 time with the screening period extended up to 4 weeks.  For 
those patients who have a repeat TG, the repeat value will be used to determine 
eligibility.  
4. Glycosylated hemoglobin, Type A1C (HbA1C) ≥10% at Week -5 (Visit S1) 
5. Persistent poor adherence with study-supplied ezetimibe and/or single-blind placebo 
study drug (ie, ingesting <80% of planned doses) or lack of tolerance to run-in 
medications assessed prior to randomization.  
6. Uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) >1.5 × the 
upper limit of normal (ULN) at Week -5 (Visit S1); 
7. Liver disease or dysfunction, including:  
• Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C 
antibodies (HCV-ABVivi) at Week -4 (Visit S2), or  
• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2.0 × 
ULN at Week -5 (Visit S1).  If total bilirubin (TB) ≥1.2 × ULN, a reflex indirect 
(unconjugated) bilirubin will be obtained, and if consistent with Gilbert’s disease or if 
the patient has a history of Gilbert’s Disease, the patient may be enrolled in the study.  
Note:  At the discretion of the investigator, a single repeat of ALT and/or AST may 
be completed prior to randomization.  For those patients who have a repeat ALT 
and/or AST, the repeat value will be used to determine eligibility.  Also, if test for 
hepatitis C antibody is positive, but optional reflexive test for hepatitis C ribonucleic 
acid (RNA) is negative, the patient can be enrolled.  
8. Renal dysfunction or glomerulonephritis, including estimated glomerular filtration rate 
(eGFR; using central laboratory determined Modification of Diet in Renal Disease 
[MDRD] formula) <30 mL/min at Week -5 (Visit S1).  Note, a single repeat qualifying 
eGFR, performed at the discretion of the investigator, is acceptable; 
9. Gastrointestinal conditions or procedures (including weight loss surgery; eg, Lap-Band® 
or gastric bypass) that may affect drug absorption;  
10. Hematologic or coagulation disorders or a hemoglobin (Hgb) level <10.0 g/dL at 
Week -5 (Visit S1); 
11. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in 
the past 5 years.  Nonmetastatic basal or squamous cell carcinoma of the skin and 
cervical carcinoma in situ are allowed  
12. Unexplained creatine kinase (CK) >3 × ULN at any time prior to randomization (ie, not 
associated with recent trauma or physically strenuous activity).  Patients with an 
explained CK elevation must have single repeat CK ≤3 × ULN prior to randomization; 


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13. History of drug or alcohol abuse within the last 2 years or reported current consumption 
of >14 alcoholic drinks/week, or any illicit drug use, history of amphetamine and 
derivatives abuse or cocaine abuse.  Subjects with amphetamine derivatives prescribed by 
and under the care of a health care practitioner can be enrolled after evaluation by the 
investigator;  
14. Blood donation, participation in a multiple blood draws, clinical study, major trauma, 
blood transfusion or surgery with or without blood loss within 30 days prior to 
randomization; 
15. Use of any experimental or investigational drugs within 30 days prior to screening.  
Patients who have enrolled in a study of an experimental small interfering RNA (siRNA) 
inhibitor of PCSK9 are excluded; 
16. Previous enrollment in a bempedoic acid clinical study. 
17. Use of any of the following drugs prior to screening (Week -5, Visit S1) or a plan to use 
these drugs during the study as follows:   
• Within 2 weeks prior to screening 
− Cholestin or red yeast rice-containing products (also known as monascus 
purpureus extract) 
• Within 4 weeks prior to screening 
− Statin doses exceeding those defined as low dose.  Doses exceeding low dose 
statin therapy are defined as an average daily dose of rosuvastatin greater than 
5 mg, atorvastatin greater than 10 mg, simvastatin greater than 10 mg, lovastatin 
greater than 20 mg, pravastatin greater than 40 mg, fluvastatin greater than 40 mg, 
or pitavastatin greater than 2 mg.  
• Within 6 weeks prior to screening for patients taking a statin 
− Gemfibrozil is not allowed in patients taking a statin as per co-administration 
instructions defined in the statin label 
• Within 3 months prior to screening:  
− Lomitapide or apheresis therapy  
− Probenecid or cyclosporine 
• Within 4 months prior to screening 
− Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors 
• Within 6 months prior to screening 
− Mipomersen 
• Cholesteryl ester transfer protein inhibitor (CETP-I) within the last 2 years prior to 
screening (Week -5, Visit S1) except for evaceptrapib within the last 3 months to 
screening (Week -5, Visit S1) 


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18. Planned initiation of the following drugs during the clinical trial or changes to the 
following drugs prior to randomization: 
• Hormone replacement (within 6 weeks prior to randomization) 
• Thyroid replacement (within 6 weeks prior to randomization) 
• Diabetes medications (within 4 weeks prior to randomization) 
• Obesity medication (4 weeks prior to randomization) 
19. New or planned dose changes of systemic corticosteroids. 
Note: Stable doses of systemic corticosteroids at screening are allowed (≥4 weeks from 
Visit S1). Topical steroids are allowed. 
20. An employee or contractor of the facility conducting the study, or a family member of the 
principal investigator, co-investigator, or Sponsor. 
21. Pregnant, breastfeeding, or intending to become pregnant within 30 days after study 
completion or last dose of study drug. 
22. Previous intolerance to ezetimibe. 
7.3. 
Patient Lifestyle and Dietary Guidelines 
Patients will be counseled to follow a lipid-lowering diet as per local or regional guidelines and 
should be encouraged (as able) to participate in a regular exercise program throughout the study.  
7.4. 
Investigator/Sponsor Suspension or Termination of Patient 
Enrollment 
If, in the opinion of the investigator, the clinical observations in the study suggest that it may be 
unwise to continue, the investigator may suspend or terminate the study at his/her site after 
consultation with the Sponsor (or designee).  A written statement fully documenting the reasons 
for such a termination will be provided to the Sponsor (or designee) and the Institutional Review 
Board (IRB) or Independent Ethics Committee (IEC).  
The Sponsor has the right to terminate the study or to close a site and remove all study materials 
from the clinical site.  A written statement will be provided to the investigator, the IRB or IEC, 
and regulatory authorities, if required.  
Possible reasons for termination of the study at a clinical site include, but are not limited to: 
• Unsatisfactory enrollment with respect to quantity or quality 
• Inaccurate or incomplete data collection on a chronic basis 
• Falsification of records 
• Failure to adhere to the protocol 
• Lack of study oversight by the principal investigator and/or designee 
If any serious or nonserious AEs have occurred at such a clinical site, all documentation relating 
to the event(s) must be obtained. 


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8. 
TREATMENT OF PATIENTS 
8.1. 
IMP Dosage and Mode of Administration 
During the double-blind treatment period, patients will ingest once daily (once every 24 hours at 
approximately the same time each day) with or without food either  
• Bempedoic acid 180-mg tablets, or 
• Matching placebo tablets 
8.2. 
Description of Investigational Medicinal Product 
Table 2: 
Investigational Medicinal Products 
 
Investigational Medicinal Product 
Product Name: 
Bempedoic acid 
Placebo 
Dosage Form: 
Film-coated tablets 
Film-coated tablets 
Unit Dose: 
180 mg 
Not applicable 
Container/Closurea 
100-count bottle with screw on, 
childproof cap 
35- and/or 100-count bottle 
(depending on visit) with screw-
on, childproof capa 
Route of Administration: 
Oral, daily, with or without food 
Oral, daily, with or without food 
Physical Description: 
 
 
a A 100-day supply of IMP will be included in the 100-count bottle and a 35-day supply of single blind placebo 
lead-in will be included in the 35-count bottle. 
Please see Pharmacy Manual for detailed storage requirements and instructions. 
8.3. 
Non-investigational Medicine Products Dose and Description 
8.3.1. 
Ezetimibe 
Eligible patients will begin single-blind treatment with study-supplied and labeled ezetimibe 
10 mg and placebo at Week -4 (Visit S2).  Treatment with study-supplied ezetimibe 10 mg will 
continue after double-blind randomization through Week 12/end of study (EOS) (Visit T4). 
Please see Pharmacy Manual for detailed storage requirements and instructions. 
8.3.2. 
Background Lipid-Lowering Therapy 
All other background lipid-lowering therapy will be ingested as prescribed by a physician 


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8.4. 
Concomitant Medications 
8.4.1. 
Lipid-Regulating Medications and Supplements 
Eligible patients will be those currently receiving stable (greater than or equal to 4 weeks prior to 
screening, Week -5, Visit S1) background statin therapy that does not exceed low dose.  Low 
dose statin therapy is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, 
simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.  
Very low dose statin therapy is defined as an average daily dose of rosuvastatin <5 mg, 
atorvastatin <10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin 
<40 mg, or pitavastatin <2 mg.  Patients unable to take any dose of statins are also eligible 
provided that statin therapy has been attempted as described above.   
Patients should continue taking their LMT throughout the study.   
PCSK9 inhibitors are not allowed during the study period.   
The ezetimibe and IMP will be study-supplied.  Patients on ezetimibe at Visit S1 will stop taking 
their supply of medication at Visit S2 and begin taking study-supplied ezetimibe. 
8.4.2. 
Prohibited Medications 
Patients should not use the following medications (monotherapies or combination therapies) 
prior to screening as defined in the exclusion criteria and below, or at any time during the study.  
• Within 2 weeks prior to screening, Week -5, Visit S1: 
− Cholestin or red yeast rice-containing products (also known as monascus 
purpureus extract)  
• Within 4 weeks prior to screening, Week -5, Visit S1: 
− Statin dose exceeding low dose as defined under inclusion criteria. 
− New or planned dose changes of systemic corticosteroids 
• Within 6 weeks prior to screening, Week -5, Visit S1 for patients taking a statin: 
− Gemfibrozil is not allowed in patients taking a statin as per co-administration 
instructions defined in the statin label 
• Within 3 months prior to screening, Week -5, Visit S1: 
− Lomitapide or apheresis therapy 
− Probenecid or cyclosporine 
• PCSK9-inhibitors within 4 months prior to screening, Week -5, Visit S1 
• Mipomersen within 6 months prior to screening, Week -5, Visit S1 
• CETP-inhibitors within the last 2 years before screening, Week -5, Visit S1 except for 
evaceptrapib within the last 3 months prior to screening (Week -5, Visit S1) 
• New or planned anti-arrhythmia medication(s) within 3 months to screening 
(Week -5, Visit S1). 


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• Any experimental or investigational drugs within 30 days before screening (Week -5, 
Visit S1).  Patients who have enrolled in a study of an experimental siRNA inhibitor 
of PCSK9 are excluded. 
8.4.3. 
Allowable Medications 
LMT not prohibited are allowed and should remain stable for at least 4 weeks prior to screening 
(Week -5, Visit S1); fibrates (with the exception of gemfibrozil which is exclusionary in patients 
taking a statin) should remain stable for at least 6 weeks prior to screening (Week -5, Visit S1).  
Use of any of the following medications are allowed if started before the randomization visit 
(Day 1, Visit T1) as defined below and are expected to remain stable through completion of the 
study:   
• Hormone replacement therapy (≥6 weeks before Day 1, Visit T1) 
• Thyroid replacement therapy (≥6 weeks before Day 1, Visit T1) 
• Diabetes medications (≥4 weeks before Day 1, Visit T1) 
• Obesity medications (≥4 weeks before Day 1, Visit T1) 
Other concomitant medications and doses must be stable for 2 weeks prior to screening and, if 
possible, not be adjusted during the study except for reasons of safety.  
8.5. 
Treatment Compliance 
8.5.1. 
Screening Compliance 
No study medication treatment will be given during the Screening period; therefore, compliance 
will not be assessed.  
8.5.2. 
Placebo Run-in and Treatment Period Adherence 
At the Week -1 (S3) visit in the placebo and ezetimibe run-in period and at each of the 
subsequent patient visits, designated clinical site staff will assess patients for ezetimibe and IMP 
adherence by counting the number of tablets that are returned as unused and by querying the 
patient with regards to daily intake.  Prior to randomization, during the ezetimibe and single-
blind run-in period, patients with ≤80% adherence to either ezetimibe or single-blind placebo 
and/or who experienced an AE judged at least possibly related to ezetimibe and/or single-blind 
placebo will not go on to randomization. 
After randomization, if the patient has not taken all doses of study drug as instructed, the patient 
will be queried for a reason, findings will be documented, and the patient will be counseled on 
the importance of carefully following all dosing instructions.  Factors contributing to poor 
adherence will be determined and, if possible, remedied.  Following randomization, patients 
demonstrating poor adherence will continue to be counseled on the importance of carefully 
following all dosing instructions, but will not be removed from the study. 
8.6. 
Blinding 
Patients who satisfy all entry criteria during the screening, complete treatment with ezetimibe 
10 mg and the single-blind placebo during the run-in period, and meet the lipid, safety, 


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tolerability, and drug adherence measures will be randomized to receive either bempedoic acid or 
placebo at Week 0 (Visit T1).  The investigator or designee will contact IWRS at this visit to 
randomize the patient into the study.   
After patients have been randomized, study drug, as assigned by the IWRS, will be administered 
in a double-blind fashion.  The Sponsor, all clinical site personnel (investigator, pharmacist, etc), 
and other vendor personnel will be blinded to the treatment group for each patient.  Patients will 
also be blinded to the treatment they receive.  Unblinded user(s) will be designated for each 
clinical site and at the Sponsor (or designee) as needed.  Unblinded individuals will be provided 
IWRS access allowing them the ability to perform emergency unblinding of treatment for an 
individual patient.  An affirmative entry of the user’s login details will be required before the 
treatment group is displayed.  Unblinding at the clinical site for any other reason will be 
considered a protocol deviation.  Unblinded treatments for patients will NOT automatically 
discontinue the patient from the study.  To discontinue the patient from the study, the appropriate 
clinical site personnel will need to register the ‘discontinuation’ visit separately.  
Blinding of treatment must be maintained for all patients unless, in the opinion of the 
investigator, the safety of the patient may be at risk.  Only under the rarest of circumstances 
should the investigator consider breaking the blind and only when medical/supportive care 
cannot be provided without determining if the patient is receiving active drug treatment.  In the 
event that the blind needs to be broken prior to completion of the study, the investigator should 
contact the appropriate Medical Monitor by telephone.  If the blind must be broken prior to 
consultation with the Medical Monitor, contact must be made within 24 hours of breaking the 
blind.  At the initiation of the study, the clinical site will be instructed on procedures for breaking 
the blind via the IWRS.  In all cases of breaking the blind, the investigator must document in the 
patient’s medical record the date, time, and reason for breaking the blind, and the names of 
personnel involved.  
Limited vendors (ie, the bioanalytical laboratory and other vendor personnel, if any, that are 
responsible for PK analysis) will have access to the randomization codes to facilitate PK 
analytical work, and will be instructed to not communicate in any manner information associated 
with treatment assignment to any personnel at the clinical site, the Sponsor, or contract research 
organization (CRO).  
Post-randomization values for individual laboratory measures for LDL-C, TG, TC, HDL-C, 
non-HDL, apoB, and hs-CRP that may inadvertently suggest treatment assignment will not be 
available to personnel from the clinical site, the patient, the Sponsor, or CRO. 
A blinded independent expert Clinical Events Committee (CEC) will adjudicate designated 
clinical endpoints, including all major adverse cardiac events (MACE) and non-MACE 
endpoints defined as:  CV death (MACE), non-CV death (non-MACE), nonfatal myocardial 
infarction [MI] (MACE), nonfatal stroke (MACE), hospitalization for unstable angina (MACE), 
coronary revascularization (MACE), non-coronary arterial revascularization (non-MACE), and 
hospitalization for heart failure (non-MACE) using standardized definitions. Any clinical 
endpoints that meet SAE criteria will be reported as SAEs. 
An independent expert Data Monitoring Committee (DMC) will formally review accumulating 
unblinded safety data from this and other ongoing studies of bempedoic acid.  


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8.7. 
Overdose 
There is no specific antidote for an overdose of bempedoic acid.  Management of an overdose 
should be focused on the treatment of symptoms.  These symptoms should be managed 
according to current standards of care with appropriate supportive measures.  Also 
discontinuation of study drug should be considered, as per medical judgement. 
In clinical studies, administration of ezetimibe, 50 mg/day to 15 healthy subjects for up to 
14 days, 40 mg/day to 18 patients with primary hyperlipidemia for up to 56 days, and 40 mg/day 
to 27 patients with homozygous sitosterolemia for 26 weeks was generally well tolerated.  One 
female patient with homozygous sitosterolemia took an accidental overdose of ezetimibe 
120 mg/day for 28 days with no reported clinical or laboratory adverse events.  In the event of an 
overdose, symptomatic and supportive measures should be employed [14]. 


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9. 
INVESTIGATIONAL MEDICINAL PRODUCT 
9.1. 
Investigational Medicinal Product Supply and Control 
The Sponsor will supply the IMP for this study.  The IMP for this study includes bempedoic acid 
(180-mg film-coated tablets) and matching placebo (film-coated tablets).  IMP will be distributed 
and released in accordance with regional and local requirements during the conduct of the study. 
The medical identification (MED ID) number (an identifier on the study drug packaging) will be 
obtained via IWRS and used to select placebo for the single-blind placebo run-in period and 
double-blind IMP for the treatment period from available clinical supplies at the clinical site.  
A 35-day supply of single-blind placebo drug will be dispensed one time at Week -4 (Visit S2) 
for the 4-week placebo run-in period of the study.  Double-blind IMP will be dispensed in one 
100-day supply increments (one 100-day supply bottle) to patients by appropriate clinical site 
personnel at Week 0 (Visit T1).  Patients will bring their bottle at each subsequent visit for 
tablets to be counted by study personnel.  After tablets have been counted, the same bottle will 
be reissued to patients at Week 4 (Visit T2) and Week 8 (Visit T3) with the bottle being returned 
to study site at Week 12/EOS for the final count.   
A 30-day supply of open-label ezetimibe 10 mg will be dispensed at Week -4 (Visit S2) for the 
run-in period of the study.  A 90-day supply will be dispensed at Week 0 (Visit T1).  Patients 
will bring their bottle to each subsequent visit for tablets to be counted by study personnel.  After 
tablets have been counted, the same bottle will be reissued to patients at Week 4 (Visit T2) and 
Week 8 (Visit T3) with the bottle being returned to study site at Week 12/EOS for the final 
count.  
Please see Pharmacy Manual for detailed storage requirements and management instructions. 
9.2. 
Administration of Investigational Medicinal Product 
Patients will be instructed to ingest study-supplied ezetimibe 10 mg and single-blind placebo 
starting at Visit S2 for the duration the placebo run-in period and the IMP starting at Visit T1 for 
the duration of treatment period orally once daily (once every 24 hours) at approximately the 
same time each day with water.  Ezetimibe and IMP may be taken with or without food.  On 
clinic visit days, patients will be instructed to delay ingestion of ezetimibe and IMP until all 
study procedures have been completed.  If a patient arrives at clinic on Visits T2, T3, or T4 
without having fasted or having taken ezetimibe and/or IMP before arriving at the clinic, the visit 
should be rescheduled for the next day or as soon as possible so that the fasting and dosing 
requirements can be met.  Patients will be instructed to return all packaging and unused IMP and 
ezetimibe at each clinic visit.  
If the patient forgets to take ezetimibe and/or IMP at the usual time on nonclinic visit days, it 
may be taken up to 12 hours later the same day.  After that time, the patient should not take the 
medication that day and should resume ingestion of the medicine the following day.  If a patient 
fails to take ezetimibe and/or IMP, details describing the reasons for nondosing should be 
documented in the patient’s medical records and electronic case report form (eCRF).  Extra 
ezetimibe and IMP (7 extra days per bottle) will be provided and can be used, if needed, prior to 


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the next visit or to replace a dose of ezetimibe or IMP that cannot be used because it is lost or 
damaged. 
9.3. 
Investigational Medicinal Product Accountability 
Accurate records of the receipt of all IMP and Sponsor-supplied ezetimibe shipped by the 
Sponsor (or designee) and the disposition of that IMP and ezetimibe must be maintained.  
IMP/ezetimibe records or logs must comply with applicable regulations, local law, and 
guidelines, and should include: 
• Amount received/placed in storage area 
• Amount currently in storage area 
• MED ID number  
• Dates and initials of person(s) responsible for inventory (including 
entry/movement/disposition) 
• Date and amount of dispensed to each patient, including unique patient identifiers 
• Date was returned by patient, assessment of compliance, and relevant documentation 
of discrepancies 
• Nonstudy disposition (eg, lost, broken, wasted) 
• Amount returned to Sponsor/Sponsor’s designee/destroyed or amount destroyed per 
local standard operating procedure (SOP) following accountability by site monitor. 
9.4. 
Investigational Medicinal Product Handling and Disposal 
Upon completion or termination of the study, all used and unused IMP with the IMP packaging 
and ezetimibe must be returned to the Sponsor (or designee) for eventual destruction unless 
otherwise authorized by the Sponsor.  All IMP returns must be accompanied by the appropriate 
documentation. 


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10. 
STUDY PROCEDURES 
10.1. 
Informed Consent 
The patient must be adequately informed of the nature and risks of the study and understand the 
informed consent document (ICD).  No study-related procedure will be performed until the 
patient has been completely informed of the study, has freely consented to take part in the study, 
and has signed and dated an ICD approved by the Sponsor (or designee) and the IRB or IEC. 
10.2. 
Procedures and Schedule of Assessments 
Patients who provide informed consent and sign the ICD will be eligible to begin screening for 
the study.  The study is comprised of 3 distinct periods:  screening, single-blind placebo and 
ezetimibe run-in, and double-blind treatment.  
The schedule of study events is provided in Appendix 1.  However, a patient can be seen at any 
time for reasons of safety.  
Data will be captured on eCRFs.  Randomization, drug supply (re)ordering, and patient tracking 
will occur via IWRS.  Instructions for these systems will be provided separately. 
10.2.1. 
Screening Week -5 (Visit S1; Day -35 to ± 7 days) 
The screening period will begin with a screening visit that will occur approximately 5 weeks 
prior to randomization.  At the investigator’s discretion, screening may be extended for an 
additional 4 weeks, if needed, to adjust background medical therapy or for other reasons as 
specified in the protocol.  Visit S1 will allow the investigator to assess the patient’s preliminary 
eligibility.  After the patient provides written informed consent (Section 10.1), the patient will 
undergo the following assessments and procedures at Visit S1: 
• Informed consent 
• Review of all inclusion/exclusion criteria that can be assessed at this time 
• Demographics 
• Clinically relevant medical history  
• Concomitant and prohibited medication review 
• Weight (kg) 
• Height (cm), BMI (kg/m2) 
• Vital signs  
• Serum pregnancy test (on appropriate female patients)/FSH 
• TSH  
• Clinical safety laboratory evaluations (hematology, blood chemistry, coagulation, and 
urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 


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• HbA1C 
• Conduct diet and exercise counseling 
• Contact IWRS to register the patient  
Patients who meet all enrollment criteria that can be assessed at Visit S1 will be instructed to 
continue their background LMT for lipid regulation and to maintain consistent diet and exercise 
patterns throughout the study.  Patients who fail to meet any entry criterion that can be assessed 
at Visit S1 are considered to be screen failures and are not required to return for additional visits 
(although a patient can be seen at any time for safety reasons). 
Under rare circumstances, patients who are considered to be screen failures due to not meeting 
stability requirements for a condition or concurrent medication that is considered to warrant 
rescreening after consultation with the Sponsor (or designee) may be rescreened.  These patients 
must be re-consented, re-registered in the IWRS, and will have a new patient ID number 
assigned. 
10.2.2. 
Placebo and Ezetimibe Run in Week -4 (Visit S2; Day -28 to ±3 days) 
Prior to scheduling Visit S2, review the screening clinical results to evaluate whether the patient 
continues to meet eligibility criteria. 
• If the patient meets eligibility criteria, then schedule the Visit S2 and proceed with the 
Visit S2 procedures 
Patients will undergo the following assessments and procedures at Visit S2:  
• Review of all inclusion/exclusion criteria that can be assessed at this time 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints (starting from signing of the 
informed consent document) 
• Physical examination 
• Electrocardiogram (ECG) 
• Vital signs 
• Serology (including HBsAg, hepatitis C antibody) 
• Conduct diet and exercise counseling 
• Dispense ezetimibe 10 mg and single-blind placebo with instructions.  If the patient is 
already taking ezetimibe, instruct patient to stop taking their personal supply of 
ezetimibe and to start taking study-supplied ezetimibe. 
• Schedule next visit 
10.2.3. 
Placebo and Ezetimibe Run-in Week -1 (Visit S3; Day -7 to ±3 days) 
Patients will undergo the following assessments and procedures at Visit S3: 
• Review of all inclusion/exclusion criteria 


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• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints  
• For patients who were not taking ezetimibe at Week -5, Visit S1, measure CK and 
blood chemistry 
• Vital signs 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG)  
• Conduct diet and exercise counseling 
• Assessment and recording of drug compliance with both single-blind placebo and 
study-supplied ezetimibe 
• Schedule next visit 
10.2.4. 
Treatment Week 0 (Visit T1; Day 1) 
Prior to scheduling Visit T1, review the information collected at Visits S1, S2, and S3 to evaluate 
whether the patient continues to meet eligibility criteria. 
• If the patient meets eligibility criteria, then schedule Visit T1 and proceed with the 
Visit T1 procedures 
If the patient has met all inclusion criteria and none of the exclusion criteria, the patient may be 
randomized into the double-blind treatment period.  Patients who fail to meet any entry criterion 
prior to randomization are considered to be screen failures, will not be randomized into a 
treatment group, and are not required to return for additional visits.  Patients are considered 
randomized once all eligibility criteria are confirmed and a randomization number is obtained by 
the IWRS on the day of first dose.  
Patients will undergo the following assessments and procedures at Visit T1: 
• Review inclusion/exclusion criteria to establish patient eligibility 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints  
• Weight 
• Vital signs 
• Urine pregnancy test (for females of childbearing potential) 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Special fasting lipids and other biomarkers (including apoB and hs-CRP) 
• HbA1C 
• Conduct diet and exercise counseling 
• Randomization 


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• Double-blind drug dispensing with instructions − bempedoic acid 180 mg and 
matching placebo 
• Ezetimibe dispensing 
• Drug return and recording of drug compliance 
• Dispense a new bottle of double-blind IMP and ezetimibe 10 mg 
• Schedule next visit 
10.2.5. 
Treatment Week 4 (Visit T2; Day 29 ±3 days) 
If the patient is withdrawing early from the study at this visit, proceed to Section 10.3 for the list 
of the required assessments. 
If the patient is withdrawing from IMP treatment at this visit, proceed to Section 10.3.1 for the 
list of the required assessments.  The patient will be asked to continue to be followed using the 
protocol-specified visit schedule.  
Patients refusing to continue to return to the clinic for protocol assessments after withdrawing 
from IMP treatment will be asked to participate in phone calls from the site at protocol-specified 
visits, or at a minimum at 12 weeks, to inquire about the patient’s current health status and 
collect information on AEs (eg, recent procedures, hospitalizations, and if the patient has died, 
the cause of death).  If the patient consents for telephone contacts, schedule the next protocol-
specified visit. 
Patients will undergo the following assessments and procedures at Visit T2: 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints 
• Vital signs 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• PK sample prior to dose 
• Conduct diet and exercise counseling 
• Record unused IMP and ezetimibe and reissue study drug bottles 
• Schedule next visit 
10.2.6. 
Treatment Week 8 (Visit T3; Day 57 ±3 days) 
If the patient is withdrawing early from the study at this visit, proceed to Section 10.3 for the list 
of the required assessments. 
If the patient is withdrawing from IMP treatment at this visit, proceed to Section 10.3.1 for the 
list of the required assessments.  The patient will be asked to continue to be followed using the 
protocol-specified visit schedule.  


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Patients refusing to continue to return to the clinic for safety assessments after withdrawing from 
IMP treatment will be asked to participate in phone calls from the site at protocol-specified 
visits, or at a minimum at 12 weeks, to inquire about the patient’s current health status and 
collect information on AEs (eg, recent procedures, hospitalizations, and if the patient has died, 
the cause of death).  If the patient consents for telephone contacts, schedule the next protocol-
specified visit. 
Patients will undergo the following assessments and procedures at Visit T3: 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints 
• Vital signs 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• PK sample prior to dose 
• Conduct diet and exercise counseling 
• Record unused study drug and reissue IMP and ezetimibe bottles 
• Schedule next visit 
10.2.7. 
Treatment Week 12/EOS (Visit T4; Day 85 ±3 days) 
Patients will undergo the following assessments and procedures at Week 12 (Visit T4) when 
completing an EOS visit or withdrawing from study (early withdrawal).  
Patients will undergo the following assessments and procedures at Visit T4: 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs and potential clinical endpoints 
• Physical Exam 
• Weight (kg) 
• 12-lead ECG 
• Vital Signs 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Special fasting lipids and other biomarkers (including apoB and hs-CRP)  
• HbA1C 
• PK sample prior to dose 
• Conduct diet and exercise counseling 
• Drug return and recording of drug compliance 


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• Complete study status in IWRS (ie, early withdrawal or completed study). 
10.3. 
Subject Withdrawal Criteria 
10.3.1. 
Early Withdrawal from the Study 
Patients must remain in the study until the last scheduled visit at Week 12 (Visit T4) to be 
considered as having completed participation in the study.  
Patients who withdraw from IMP and/or ezetimibe prior to Week 12 (Visit T4) for any reason 
will be asked to continue to be followed for safety assessments, including basic fasting lipids, at 
clinic visit following the protocol-specified visit schedule (see Appendix 1).   
Patients who temporarily withdraw from IMP and/or ezetimibe prior to Week 12 (Visit T4) for 
any reason may restart IMP and/or ezetimibe providing that (1) the patient and the investigator 
are in agreement regarding this course of action, (2) the patient has been off of IMP for 4 weeks 
or less; and (3) IMP can be started as soon as possible.  For cases where the patient has been off 
of IMP for more than 4 weeks, the investigator must contact the medical monitor for approval 
prior to restarting IMP. 
Patients who refuse to continue to return to the clinic for safety assessments will be asked to 
participate in phone calls from the site at protocol-specified visits (see Appendix 1), or at a 
minimum at 12 weeks, to collect information on AEs, concomitant medications, and current 
health status.   
The patient’s decision to participate in the clinical study is voluntary.  Patients may refuse to 
continue in the study and/or withdraw from participation in this study at any time, for any reason, 
specified or unspecified, and without penalty or loss of benefits to which the patient is otherwise 
entitled.  
It is the right and duty of the investigator to interrupt the treatment of any patient whose health or 
well-being may be threatened by continuation in this study.  Such patients should be withdrawn 
from the study and should not be continued under a modified regimen. 
Patients who are withdrawn from the study may not re-enter.  The reasons for withdrawal from 
this study may include: 
• Patient’s withdrawal of consent 
• Failure to comply with the protocol 
• Lost to follow-up 
• Illness, condition, or procedural complication (including AEs) affecting the patient’s 
ability to participate or requiring prohibited medication 
• The Sponsor or investigator terminates the study  
• In the investigator’s judgment, it is deemed in the best interest of the patient to 
discontinue his/her participation in the study 
• Any other reason 


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If a patient is lost to follow-up, every reasonable effort must be made by the clinical site 
personnel to contact the patient and determine the reason for discontinuation/withdrawal.  The 
measures taken to follow-up must be documented. 
10.3.2. 
Procedures for Early Withdrawal 
If a patient withdraws or is removed from the study for any reason, the patient should complete 
an End of Study visit.  Reason for withdrawal, date of the discontinuation, and date of the last 
dose of study drug should be recorded in the appropriate section of the eCRF.  Additionally, the 
discontinuation visit date must be registered in IWRS.  Study drug assigned to the withdrawn 
patient may not be assigned to another patient. 
All effort should be made to have each patient complete all study visits on schedule according to 
the protocol.  Accommodations for early or late visits in special circumstances will be considered 
by the Sponsor to prevent early withdrawal.  Written notice (regardless of cause) is to be 
provided within 48 hours of the withdrawal to the Sponsor personnel or the Medical Monitor.  At 
the time of discontinuation, every effort should be made to ensure all relevant procedures and 
evaluations scheduled for the final study visit are performed.  Except in the case of a medical 
emergency, the procedures and assessments detailed in Section 10.3 will be performed upon the 
discontinuation of the study. 


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11. 
ASSESSMENT OF SAFETY 
11.1. 
Safety Parameters 
At all clinic visits, investigators will review all safety information including vital signs, AEs, 
concomitant medications, and ECG reports and will ensure that the collected data are recorded 
into the appropriate eCRF.  Additionally, clinical laboratory samples will be collected and sent 
for analysis and the investigator will review the results to ensure continued patient safety while 
participating in the study.  
11.1.1. 
Demographic/Medical History 
Demographic data and a complete medical history will be obtained from the patient.  For medical 
history, conditions that are relevant and/or clinically significant should be captured with at least a 
start date (month and year) and whether the condition is ongoing or resolved.  All surgeries 
regardless of date should be reported.  
11.1.2. 
Vital Signs 
Vital signs will include diastolic and systolic blood pressure as well as heart rate. 
The patient should sit quietly for 5 minutes prior to collection of vital signs.  At all time points, 
vitals will be collected prior to blood collection.  Blood pressure and heart rate will be measured 
using a calibrated, fully automated machine with a cuff that is appropriate to the size of the upper 
arm.  If a fully automated machine is not available, blood pressure may be measured manually.  
The same method (either automated or manual) and the same arm (right or left) must be used 
throughout the study.  The patient should be in a seated position with feet touching the floor.  
Patients should be seated quietly for at least 5 minutes in a chair with their backs supported, their 
feet flat on the ground, and their arms bared and supported at heart level. 
11.1.3. 
Weight, Height, and Body Mass Index 
Body weight will be measured in the morning using consistent scales while the patient is fasting, 
after voiding, and without shoes and outerwear (eg, coats).  
Height will be measured using standard clinic procedures.  
BMI will be calculated using the formula:  
BMI (kg/m2) = weight in kg / (height in meters)2 
11.1.4. 
Physical Examination 
Physical examinations (PE) will include an assessment of the following: 
• General appearance 
• Skin 
• Eyes, ears, nose, and throat 
• Head and neck 


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• Extremities 
• Musculoskeletal examination 
• Respiratory examination 
• Cardiovascular assessment, including rhythm and presence of cardiac abnormalities 
• Abdominal examination 
• Neurologic examination including documentation of the presence of abnormalities in 
mental status and motor and sensory function 
• Any additional assessments necessary to establish baseline status or evaluate 
symptoms or adverse experiences 
Documentation of the PE findings will be included in the source documentation at the clinical 
site.  Significant findings prior to the start of study drug will be recorded on the Medical 
History/Current Medical Conditions page of the eCRF.  Only changes from baseline physical 
examination findings that meet the definition of an AE will be recorded on the AE page of the 
eCRF. 
Note:  Additional information will be collected regarding muscle-related AEs.  See 
Section 12.7.2. 
11.1.5. 
Electrocardiogram 
ECG collection will be preceded by a 10-minute rest time during which the patient will remain in 
the supine position.  At each time point, ECGs will be collected prior to blood collection.  ECGs 
will be assessed using machine readings and physician review. 
11.1.5.1. Monitoring and Management of Abnormal Electrocardiograms 
If a clinically significant ECG abnormality not present at baseline (screening) is determined by 
the investigator to be related to study drug, the abnormality will be discussed with the Sponsor 
personnel or the authorized Medical Monitor.  The event will be followed and evaluated with 
additional tests (if necessary) until the underlying cause is determined or the event is brought to 
an acceptable resolution.  Additional clinical and laboratory information will be collected and 
carefully documented in order to better characterize the ECG abnormality and rule out 
alternative causes.  ECG findings determined to be a clinically significant change from baseline 
should be reported as an AE regardless of causality. 
Unscheduled ECG assessments will be completed at the discretion of the investigator. 
11.1.6. 
Clinical Laboratory Tests 
11.1.6.1. Laboratory Parameters (Safety) 
Patients will be in a seated position during the blood collection.  Clinical laboratory parameters 
and tests will include those listed in Table 3.  Collection schedule, schedule of laboratory 
parameters by visit, and instructions are in the Clinical Laboratory Manual provided by the 
Central Laboratory. 


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Table 3: 
Clinical Laboratory Parameters (Safety) 
Clinical Laboratory Test 
Clinical Laboratory Test 
Hematology 
• 
Hematocrit (Hct) 
• 
Hemoglobin (Hgb) 
• 
Mean corpuscular hemoglobin (MCH) 
• 
Mean corpuscular hemoglobin 
concentration (MCHC) 
• 
Mean corpuscular volume (MCV) 
• 
Platelet count 
• 
Red blood (RBC) cell count 
• 
White blood (WBC) cell count with 
differential (absolute and %) 
Blood Chemistry (serum, fasting) 
• 
Albumin (Alb) 
• 
Alkaline phosphatase (ALK-P) 
• 
Alanine aminotransferase (ALT; serum 
glutamic pyruvic transaminase [SGPT]) 
• 
Aspartate aminotransferase (AST; 
serum glutamic oxaloacetic 
transaminase [SGOT]) 
• 
Blood urea nitrogen (BUN) 
• 
Calcium (Ca) 
• 
Carbon dioxide (CO2) 
• 
Chloride (Cl) 
• 
Creatinine 
• 
Creatine kinase (CK) 
• 
Glucose 
• 
Lactate dehydrogenase (LDH) 
• 
Phosphorus 
• 
Potassium (K) 
• 
Sodium (Na) 
• 
Total bilirubin (TB)a 
• 
Total protein 
• 
Uric acid 
Urinalysis (Dipstick) 
• 
Clarity 
• 
Bilirubin 
• 
Color 
• 
Glucose 
• 
Ketones 
• 
Leukocyte esterase 
• 
Nitrite 
• 
Occult blood 
• 
pH 
• 
Protein 
• 
Specific gravity 
• 
Urobilinogen 


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Table 3: 
Clinical Laboratory Parameters (Safety) (Continued) 
Clinical Laboratory Test 
Clinical Laboratory Test 
Urinalysis (Microscopic)-only if urine dipstick 
abnormal 
Coagulation (screening for all patients, T1 and 
3-5 days after T1 in patients receiving 
anticoagulation therapy, only) 
• 
Bacteria 
• 
Casts 
• 
Crystals 
• 
Epithelial cells 
• 
RBC 
• 
WBC 
• 
Prothrombin time (PT) 
• 
International normalized ratio (INR) 
Other Screening Labs 
Additional samples 
• 
Hepatitis B surface antigen (HBsAg) 
• 
Hepatitis C virus (HCV)b 
• 
Serum pregnancy test (only for females 
of childbearing potential) 
• 
Follicle-stimulating hormone (FSH; 
Females <55 years and >1 year without 
menses) 
• 
Urine pregnancy test prior to 
randomization (for female of child 
bearing potential) 
• 
Thyroid-stimulating hormone (TSH) 
• 
Hemoglobin A1C (HbA1C) 
a If TB ≥1.2 × ULN, a reflex indirect (unconjugated) bilirubin will be obtained. 
b If hepatitis C antibody (HCV-AB) is positive, a reflex HCV RNA will be performed to rule out active disease. 
11.1.6.2. Sample Collection, Storage, and Shipping 
Clinical laboratory samples will be collected by appropriate clinical site personnel and then 
shipped according to a separate laboratory manual provided by the central laboratory.   
Blood draws for lipids, TG, and glucose must meet the fasting criterion listed below.  If this 
criterion has not been met, these blood samples will NOT be collected.  If this criterion can be 
met by rescheduling the clinic visit to occur within 3 days, the lipid, TG, and/or glucose blood 
samples will be collected at the rescheduled clinic visit only.  
• Blood samples will be drawn after a minimum 10-hour fast (water is allowed) 
11.1.6.3. General Monitoring and Management of Abnormal Clinical Labs 
It is the investigators’ responsibility to review the results of all laboratory tests as they become 
available and to sign and date the report to document their review.  For each laboratory test 
outside of the laboratory normal range, the investigator needs to ascertain if this is a clinically 
significant change from baseline for the individual patient, with baseline defined as the last value 


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or observation before the first dose of study drug.  The investigator may repeat the laboratory test 
or request additional tests to verify the results of the original laboratory test. 
If a laboratory value is determined to be an abnormal and clinically significant change from 
baseline for the patient, the investigator should determine if it qualifies as an AE (as described 
below), and if yes, an appropriate eCRF will be completed.  All clinically significant laboratory 
abnormalities occurring during the study that were not present at baseline should be followed and 
evaluated with additional tests if necessary, until diagnosis of the underlying cause or resolution.  
Specific monitoring and management guidelines for laboratories of special interest are outlined 
in the sections below. 
An abnormal laboratory value that is not already associated with an AE is to be recorded as an 
AE only if any one of the following criteria is met: 
• an action on the study drug is made as a result of the abnormality 
• intervention for management of the abnormality is required 
• at the discretion of the investigator should the abnormality be deemed clinically 
significant 
11.1.6.3.1. Monitoring and Management of Elevated Liver Function Tests 
If at any time after randomization a patient experiences a new ALT and/or AST >3 × ULN, the 
patient will undergo repeat confirmatory liver function test (LFT) assessment as soon as is 
reasonably possible, preferably within 3 to 7 days of the laboratory result becoming available.  
Repeat LFT assessment will include:  (1) measurement of ALT, AST, alkaline phosphatase, total 
and direct bilirubin, prothrombin time (PT)/international normalized ratio (INR), eosinophil 
count, CK, antihepatitis A virus (total), HBsAg (confirmation of screening measurement), 
hepatitis C virus (HCV) (confirmation of screening measurement), and anti-
cytomegalovirus/immunoglobulin M; (2) history of concomitant medication use; (3) history of 
exposure to environmental chemical agents, including ethanol; and (4) query for related 
symptoms.  Additionally, further testing such as liver ultrasound or magnetic resonance imaging 
(MRI) scanning may be warranted to rule out additional pathology depending on clinical 
presentation and should be discussed with the Sponsor personnel or the authorized Medical 
Monitor.  
• If repeat LFT assessment confirms ALT and/or AST >3 × ULN, consideration should 
be given to withdrawing the patient and administering no further doses of study drug.  
At the investigator’s discretion, study drug may be interrupted and the patient 
rechallenged with study drug after LFTs have returned to baseline levels.  
• If repeat LFT assessment confirms ALT and/or AST >5 × ULN, patient should be 
withdrawn from IMP treatment, but will be asked to continue to be followed for 
safety using the protocol-specified visit schedule (see Appendix 1) or more frequently 
as determined by the investigator. 
• If repeat LFT assessment confirms ALT and/or AST >3 × ULN in addition to any of 
the following, the patient should be given no further IMP treatment, but will be asked 


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to continue to be followed for safety using the protocol-specified visit schedule (see 
Appendix 1) or more frequently as determined by the investigator: 
− TB >2 × ULN 
Note:  In the case of patients with Gilbert’s disease, TB will be fractionated and 
the determination of 2 × ULN will be based upon direct (conjugated) bilirubin. 
− INR >1.5 × ULN (unless the patient is on stable dose of anticoagulation 
medication) 
− Appearance or worsening of right upper abdominal discomfort, anorexia, fatigue, 
nausea, vomiting, fever, rash, or eosinophilia 
11.1.6.3.2. Monitoring and Management of Elevated Serum Creatinine 
If at any time after randomization, a patient experiences a decrease in eGFR to the level of 
15 mL/min/1.73 m2) or if the patient experiences acute renal failure, the patient should be 
withdrawn from IMP treatment but will be asked to continue to be followed for safety using the 
protocol-specified visit schedule (see Appendix 1) 
11.1.6.3.3. Monitoring and Management of Hemoglobin Change 
If at any time after randomization a patient experiences a Hgb decrease >2.0 g/dL (20 g/L) from 
baseline (Week 0 [Visit T1]), the patient will undergo repeat confirmatory hematology testing as 
soon as is reasonably possible, preferably within 3 to 7 days of the laboratory result becoming 
available.  
Repeat hematology assessment will include:  (1) measurement of Hgb, hematocrit (Hct), mean 
corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular 
volume, platelet count, reticulocyte count (percent and absolute), red blood cell count (RBC), 
and white blood cell count (WBC) with differential (absolute values only); (2) history of 
concomitant medication use; and (3) query for related symptoms.  Additionally, further testing 
may be warranted to rule out additional pathology depending on clinical presentation, and should 
be discussed with Sponsor personnel or the authorized Medical Monitor.  
• If repeat Hgb assessment confirms a decrease >2.0 g/dL (20 g/L) from baseline, the 
patient should be monitored carefully during the study and return at 2-week intervals 
after study completion for additional Hgb measurement until the level returns to 
baseline or reaches a stable level.  
• If repeat Hgb assessment confirms Hgb <8 g/dL (80 g/L), the patient should be 
withdrawn from IMP treatment.  The patient will return at 1-week intervals after 
withdrawing from IMP treatment for additional Hgb measurement until the level 
returns to baseline or reaches a satisfactory conclusion. 
• If the patient is withdrawn from IMP treatment, the patient should be asked to 
continue being followed for safety using the protocol-specified visit schedule (see 
Appendix 1). 
At any time, the investigator may choose to consult with a specialist to further evaluate the cause 
of the alteration in Hgb. 


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11.1.6.3.4. Monitoring and Management of Elevated Creatine Kinase 
If at any time after randomization a patient experiences a marked CK elevation >5 × ULN, the 
patient will undergo repeat confirmatory assessment as soon as is reasonably possible, preferably 
within 3 to 7 days of the laboratory result becoming available.  
Repeat CK assessment will include query for related symptoms.  
• If the repeat CK assessment confirms an unexplained (ie, not associated with recent 
trauma or physically strenuous activity) CK abnormality >5 × ULN, if asymptomatic 
the patient should receive further assessment and investigation into the cause, assess 
whether there is renal injury, and measure CK approximately weekly or more 
frequently if clinically indicated until resolution.  If CK levels continue to rise; IMP 
and study-supplied ezetimibe should be discontinued.   
• If symptomatic, the following steps should be completed: 
− Hold IMP and study-supplied ezetimibe 
− Clarification of the nature, duration, and intensity of muscle symptoms 
− Review possible predisposing factors, such as unaccustomed exercise, heavy 
alcohol intake, viral illness (consider performing serology)  
− Evaluation for additional diagnoses or other conditions which can cause 
myopathy including muscle tenderness (by PE), weakness, rash, measurement of 
serum creatinine, dipstick urinalysis with microscopy if indicated 
− Obtain clinical chemistries to assess the possibility of lactic acidosis 
− Follow symptoms and CK until the abnormality has resolved 
− If based on the above evaluation an alternative explanation is suspected, 
consideration can be given to resuming IMP once CK returns to baseline levels 
− If no alternative explanation exists, consideration should be given to withdrawing 
the patient from IMP treatment.  
• If the repeat CK assessment confirms an unexplained (ie, not associated with recent 
trauma or physically strenuous activity) CK abnormality as listed below, the patient 
should be withdrawn and given no further doses of study drug:  
− >10 × ULN, even in the absence of symptoms.  
− In all cases, evaluate the signs/symptoms and laboratory evaluations as outlined 
above. 
• If the patient is withdrawn from IMP treatment, the patient should be asked to 
continue being followed for safety using the protocol-specified visit schedule (see 
Appendix 1). 


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11.1.6.3.5. Monitoring and Management of Potential Hypoglycemia and Metabolic Acidosis 
Patients will be educated on the signs and symptoms of hypoglycemia.  If such signs and 
symptoms are experienced, patients will be instructed to report these signs and symptoms to the 
investigator.  
During each study visit, patients will be reminded to report all signs and symptoms associated 
with hypoglycemia to the investigator.  For each occurrence of patient-reported signs and 
symptoms associated with hypoglycemia, the investigator will discuss these symptoms with the 
patient and assess whether they are attributable to hypoglycemia or to another potential cause.  
All investigator-confirmed occurrences of hypoglycemia will be recorded as an AE.  All 
occurrences of signs and symptoms that are not confirmed by the investigator to be attributable 
to hypoglycemia will be reported using the appropriate diagnosis. 
Clinical laboratories will be assessed to determine any signs of anion gap metabolic acidosis.  If 
laboratories are consistent with metabolic acidosis, immediate follow up with the patient for 
further medical evaluation of the acidosis.  This event should be captured as an AE. 
11.1.6.3.6. Monitoring and Management of Elevated Triglycerides 
Patients may continue to use stable doses of TG-lowering medications during the study.  An 
adjunctive therapy plan is in place for those patients whose TG values meet the protocol-defined 
threshold criteria.  Post-randomization, TG results will be masked to investigators in order to 
maintain the blind; however, a threshold has been set to notify investigators and provide an 
opportunity to adjust the patient’s standard of care regimen.  Beginning at Week 4 (Visit T2), if 
the TG level exceeds 1000 mg/dL (11.3 mmol/L) while on treatment, the investigator will 
receive notification from the central laboratory that the patient has met or exceeded the protocol-
defined threshold criteria for TG.  The investigator will initiate the following plan: 
• Any patient with TG >1000 mg/dL (11.3 mmol/L), will be reminded to fast for at 
least 10 hours and will return to clinic within 1 week for a repeat, fasting TG sample 
to confirm the TG value meets the threshold criteria  
• Any patient with a confirmed TG >1000 mg/dL (11.3 mmol/L) may initiate standard-
of-care therapy to lower TG using a patient-specific prescription.  The initiation of 
this medication will be documented on the case report form as a concomitant 
medication with the associated start date.  These medications will not be provided by 
the Sponsor. 
• Patients continuing to exceed the TG threshold after maximizing the standard-of-care 
triglyceride-lowering therapy will be discontinued from IMP treatment and will be 
asked to continue to be followed for safety using the protocol-specified visit schedule 
(see Appendix 1). 
• Please see the Clinical Laboratory Manual and Section 11.1.6.2 for sample collection 
and instructions. 
11.1.6.4. Pharmacokinetic Assessments 
Pharmacokinetic assessments to measure plasma concentrations of ETC-1002 and its metabolite 
ESP15228 will be conducted from 6 mL whole blood samples collected.  At the time of sample 


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collection, the date and time of blood draw and the last 2 doses of study medication will be 
collected.  Pharmacokinetic sample analyses for ETC-1002 and ESP15228 will be conducted by 
the bioanalytical laboratory. 
11.1.6.5. Collection and Assessment of Pharmacokinetic Samples 
Pharmacokinetic samples will be collected from patients prior to dose at Week 4 (Visit T2), 
Week 8 (Visit T3), and Week 12 (Visit T4), dosing time and PK sampling time must be 
documented, for use in further developing the population PK model.  
Plasma concentrations of ETC-1002 and its metabolite (ESP15228) will be determined using 
validated methods.  Plasma PK samples will be labeled with preprinted information, including 
study number, patient identification number, study day, nominal time of sample collection, 
matrix, and a text identification (ie, “Plasma PK”).  See the study laboratory manual for further 
instructions. 
11.1.6.6. Shipment of Pharmacokinetic Samples 
Plasma PK samples will be shipped frozen on dry ice according to instructions provided in the 
laboratory manual. 
11.1.6.7. Total Blood Volume of Clinical Laboratory and Pharmacokinetic Samples 
The total number of venipunctures and total volume of whole blood collected during the study 
will be limited to that needed for safety monitoring, PK, efficacy, and biomarker assessment.  
Total whole blood volume collected over the study duration is not to exceed approximately 
250 mL for each patient. 
11.2. 
Adverse and Serious Adverse Events 
11.2.1. 
Definition of Adverse Events 
An AE is any untoward medical occurrence in a clinical investigation patient administered a 
pharmaceutical product, including control, and which does not necessarily have a causal 
relationship with treatment.  
An AE can be: 
• Any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of a medicinal product, 
whether or not considered related to the medicinal product 
• Any new disease or exacerbation of an existing disease 
• Any deterioration in nonprotocol-required measurements of laboratory value or other 
clinical test (eg, ECG or x-ray) that results in symptoms, a change in treatment, or 
discontinuation from study drug 
• TEAEs are defined as AEs that begin or worsen after the first dose of study drug 
• Adverse drug reaction (ADR; see Section 11.2.2) 


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11.2.2. 
Adverse Drug Reaction 
All noxious and unintended responses to a medicinal product related to any dose should be 
considered an ADR.  “Responses” to a medicinal product means that a causal relationship 
between a medicinal product and an AE is at least a reasonable possibility (ie, the relationship 
cannot be ruled out). 
An unexpected ADR is defined as an adverse reaction, the nature or severity of which is not 
consistent with the applicable product information (eg, IB for an unapproved investigational 
product or package insert/summary of product characteristics for an approved product). 
11.2.3. 
Reporting  
All AEs occurring during the course of the study (starting from signing informed consent to 
study completion or discontinuation) will be collected on the AE eCRF. Patients should be 
instructed to report any AE that they experience through 30 days following the last dose of IMP 
to the investigator.  Any SAE that occurs within 30 days following the last study visit should be 
reported to the Sponsor per Section 11.3.  Beginning with Visit S2 (Week -4), investigators 
should make an assessment for AEs at each visit and record the event on the appropriate AE 
eCRF.  
Wherever possible, a specific disease or syndrome rather than individual associated signs and 
symptoms should be identified by the investigator and recorded on the eCRF.  However, if an 
observed or reported sign or symptom is not considered a component of a specific disease or 
syndrome by the investigator, it should be recorded as a separate AE on the eCRF.  Additionally, 
the condition that led to a medical or surgical procedure (eg, surgery, endoscopy, tooth 
extraction, transfusion) should be recorded as an AE, not the procedure.  
Any medical condition already present at screening or baseline should not be reported as an AE 
unless the medical condition or signs or symptoms present at baseline change in severity or 
seriousness at any time during the study.  In this case, it should be reported as an AE. 
Clinically significant abnormal laboratory or other examination (eg, ECG) findings that are 
detected during the study or are present at baseline and significantly worsen during the study 
should be reported as AEs.  The investigator will exercise his or her medical and scientific 
judgment in deciding whether an abnormal laboratory finding or other abnormal assessment is 
clinically significant.  Significant abnormal laboratory values occurring during the clinical study 
will be followed until repeat tests return to normal, stabilize, or are no longer clinically 
significant.  Any abnormal test that is determined to be an error does not require reporting as an 
AE. 
Each AE is to be evaluated for duration, severity, seriousness, and causal relationship to the 
investigational drug.  For each AE, the following information will be recorded: 
• Description of the event (eg, headache) 
• Date of onset 
• Date of resolution (or that the event is continuing) 
• Action taken as a result of the event 
• Seriousness of the event 


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• Severity of the event 
• Outcome of the event 
• Investigator’s assessment of relationship to study drug 
A cluster of signs and symptoms that results from a single cause should be reported as a single 
AE (eg, fever, elevated WBC, cough, abnormal chest x-ray, etc, can all be reported as 
“pneumonia”). 
The investigator will carefully evaluate the comments of the patient and the response to 
treatment in order that he/she may judge the true nature and severity of the AE.  The question of 
the relationship of AEs to study drug administration should be determined by the investigator or 
study physician after thorough consideration of all facts that are available. 
Additional information will be collected regarding muscle-related AEs that may include, but may 
not necessarily be limited to, a muscle-related questionnaire, with questions regarding type of 
muscle-related symptoms, location of the muscle-related AE, and potential cause of the muscle-
related AE.  
11.2.4. 
Severity 
It is the investigator’s responsibility to assess the intensity (severity) of an AE.  
The severity of the AE will be characterized as mild, moderate, or severe according to the 
following definitions: 
• Mild:  Events are usually transient and do not interfere with the patient’s daily 
activities 
• Moderate:  Events introduce a low level of inconvenience or concern to the patient 
and may interfere with daily activities  
• Severe:  Events interrupt the patient’s usual daily activity, are incapacitating with 
inability to do usual activities, or significantly affect clinical status and warrant 
intervention and/or close follow-up 
Note:  A severe AE need not be serious and an SAE need not, by definition, be severe. 
11.2.5. 
Relationship 
It is the investigator’s responsibility to assess the relationship of the AE to both the IMP and 
ezetimibe.  The degree of “relatedness” of the AE to the IMP and ezetimibe should be described 
using the following scale: 
• Not Related:  No temporal association and other etiologies are likely the cause. 
• Unlikely:  While cannot be definitively ruled as not related to IMP, a causal 
association is remote, and other etiologies are more likely to be the cause.  For 
reporting and summarization, events assessed as “Unlikely” to be related to IMP will 
be considered as “Not Related” to IMP for regulatory reporting purposes.  
• Possible: Temporal association, but other etiologies are likely the cause.  However, 
involvement of the study drug cannot be excluded. 


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• Probable:  Temporal association, other etiologies are possible but unlikely.  The event 
may respond if the study drug is discontinued. 
• Definite:  Established temporal association with administration of the study drug with 
no other more probable cause.  Typically, the event should resolve when the study 
drug is discontinued and recur on re-challenge. 
11.2.6. 
Monitoring and Follow-up of Adverse Events 
Patients having AEs will be monitored with relevant clinical assessments and laboratory tests, as 
determined by the investigator.  All follow-up results are to be reported to the Sponsor personnel 
or the authorized Medical Monitor.  Any actions taken and follow up results must be recorded 
either on the appropriate page of the eCRF or in appropriate follow-up written correspondence, 
as well as in the patient’s source documentation.  Follow-up laboratory results should be filed 
with the patient’s source documentation. 
For all AEs that require the patient to be discontinued from the study, relevant clinical 
assessments and laboratory tests must be repeated at appropriate intervals until final resolution, 
stabilization of the event(s), or until the patient is lost to follow-up or dies. 
Patients with AEs that are ongoing at study completion or study withdrawal must be followed 
until resolution or for 30 days after the last study visit, whichever comes first (see Section 11.3). 
11.2.7. 
Treatment-Emergent Adverse Events 
TEAE are defined as AEs that begin or worsen after the first dose of study drug. 
11.2.7.1. Definition of Serious Adverse Event  
An SAE is defined as any AE occurring at any dose that results in any of the following 
outcomes:  
• Results in death 
• Is life threatening 
• Requires in-patient hospitalization or prolongation of existing hospitalization 
• Results in persistent or significant disability/incapacity, or substantial disruption of 
the ability to conduct normal life functions 
• Is a congenital anomaly/birth defect 
• An important medical event 
Note:  Hospitalization is defined as a formal inpatient admission.  This will not include 
admissions under “23-hour Observational Status”, an emergency room visit without hospital 
admission, or an urgent care visit and therefore such events will not be recorded as an SAE under 
this criterion, nor will hospitalization for an elective or outpatient procedure scheduled or 
planned before signing of informed consent.  However, unexpected complications and/or 
prolongation of hospitalization that occur during elective or outpatient surgery should be 
recorded as AEs and assessed for seriousness.  Admission to the hospital for social or situational 


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reasons (eg, no place to stay, live too far away to come for hospital visits) will not be considered 
inpatient hospitalizations.  
Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, they 
may jeopardize the patient and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition.  Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room, blood dyscrasias, 
convulsions that do not result in inpatient hospitalization, or the development of drug 
dependency or drug abuse. 
Any clinical endpoints that meet SAE criteria will be also reported as SAEs.  The CEC will 
adjudicate clinical endpoints in a blinded fashion, but the DMC will review clinical endpoints 
and SAEs in an unblinded fashion. 
11.2.7.2. Definition of Serious Adverse Events or Outcomes not Qualifying as Serious 
Adverse Events 
The following are not considered SAEs and therefore do not need to be reported as such: 
• Preplanned or elective hospitalization including social and/or convenience situations 
(eg, due to inclement weather) 
• Overdose of either Esperion study drug or concomitant medication unless the event 
meets SAE criteria (eg, hospitalization).  However, the event should still be captured 
as a nonserious AE on the appropriate eCRF page 
11.2.7.3. Clinical Laboratory Assessments as Adverse Events and Serious Adverse Events 
It is the responsibility of the investigator to assess the clinical significance of all abnormal values 
as defined by the list of reference ranges from the local laboratory.  In some cases, significant 
changes in lab values within the normal range will require similar judgment. 
11.3. 
Reporting Serious Adverse Events 
All SAEs, regardless of relationship to study drug, occurring from the time of informed consent 
until 30 days following the last dose of IMP (for most patients 30 days following their Week 12 
visit), must be reported by the principal investigator or designee to the authorized safety designee 
within 24 hours of the principal investigator or the clinical site becoming aware of the 
occurrence.  All SAEs that the investigator considers related to study drug that occur after the 
30-day follow-up of the study period must be reported to the Sponsor.  
To report the SAE, complete the provided SAE form and submit it to the safety designee within 
24 hours of becoming aware of the occurrence.  
The investigator is required to submit SAE reports to the IRB/IEC in accordance with local 
requirements.  All investigators involved in studies using the same investigational product will 
receive any safety alert notifications for onward submission to their local IRB as required.  All 
reports sent to investigators will be blinded. 
All SAEs should be recorded on the eCRF and source documents.  Criteria for documenting the 
relationship to study drug and severity will be the same as those previously described. 


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The investigator must continue to follow the patient until the SAE has subsided or until the 
condition becomes chronic in nature, stabilizes (in the case of persistent impairment), or the 
patient dies. 
Within 24 hours of receipt of follow-up information, the investigator must update the SAE form 
and submit any supporting documentation (eg, patient discharge summary or autopsy reports) to 
the safety designee.  
11.3.1. 
Reporting of Serious Adverse Events to Regulatory Authorities 
The Sponsor (and/or designee) is responsible for submitting expedited reports of suspected and 
unexpected serious adverse reactions (SUSARS) to the appropriate regulatory authorities.  All 
investigators participating in ongoing clinical studies with the study drug will be notified by the 
Sponsor (or designee) of SUSARs.  SUSARS must be communicated as soon as possible to the 
appropriate IRB/IEC by the investigator, as applicable and/or reported in accordance with local 
laws and regulations.  Investigators should provide written documentation of IRB/IEC 
notification for each report to the Sponsor. 
SAEs that are anticipated to occur in this patient population will be collected and reported by the 
investigator as described in Section 11.3.  However, these events will not be submitted to the 
regulatory authorities as expedited reports unless they meet SUSAR criteria.  These events that 
are considered to be exempt from expedited reporting include the following clinical endpoints: 
• CV death 
• Nonfatal MI 
• Nonfatal stroke 
• Unstable angina requiring hospitalization 
• Coronary revascularization 
• Heart failure requiring hospitalization 
• Noncoronary arterial revascularization 
11.3.2. 
Reporting of Patient Death 
The death of any patient during the study, or within the 30-day follow-up period after they have 
completed the study (regardless of the cause), must be reported as detailed in Section 11.3. 
11.3.3. 
Reports of Pregnancy 
Although not considered an SAE (unless the event occurs with a serious outcome), pregnancy 
information on female patients will be collected by the authorized safety designee.  If a female 
patient becomes pregnant during the course of the study, study treatment should be discontinued 
immediately.  The principal investigator or designee must complete and submit the Pregnancy 
Report Form within 24 hours of awareness of the pregnancy.  In addition, patients who become 
pregnant will complete the Week 12/End of Study evaluations according to Appendix 1.  
Whenever possible, pregnancies should be followed until outcome and the Pregnancy Outcome 
Reporting Form submitted to the safety designee once the outcome is known.  


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11.4. 
Adverse Events of Special Interest 
Adverse events of special interest (AESI) include metabolic acidosis (clinical laboratories), 
hepatic, muscular (AE and CK evaluation), new onset diabetes/hyperglycemia, renal, 
cardiovascular, and neurocognitive/neurologic events.  Based on previous experience with 
bempedoic acid, uric acid and hemoglobin will be closely monitored.  Safety monitoring 
guidelines for hemoglobin are detailed in Section 11.1.6.3.3.  Specific monitoring guidelines are 
provided in the case of AEs uncovered through laboratory evaluations.  Patients are to be queried 
at each study visit regarding changes in cognition and or signs/symptoms of hypoglycemia. 
The protocol procedures included in the bempedoic acid clinical studies are part of standard 
clinical care for patients with elevated LDL-C and also address the potential and theoretic risks 
of bempedoic acid.  
All bempedoic acid studies will include standard pharmacovigilance including evaluation of 
AEs, PE findings, vital signs, and laboratory assessments.  Cardiovascular events will be 
adjudicated by an independent CEC in accordance with a prespecified charter.  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 


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11.5. 
Data Monitoring Committee 
An independent DMC will monitor unblinded accumulating patient safety and efficacy data until 
the last patient has completed study treatment.  In addition, data on SAEs and deaths, including 
clinical endpoints, will be monitored by the DMC during this period.  At each DMC review, 
relevant unblinded safety and efficacy information from ongoing studies of bempedoic acid will 
be provided to the DMC by an independent unblinded statistician and programmer.  Additional 
details will be provided in a DMC Charter. 
11.6. 
Clinical Event Committee 
A blinded independent expert CEC will adjudicate designated clinical endpoints, including all 
MACE and non-MACE endpoints defined as: CV death (MACE), non-CV death (non-MACE), 
nonfatal MI (MACE), nonfatal stroke (MACE), hospitalization for unstable angina (MACE), 
coronary revascularization (MACE), non-coronary arterial revascularization (non-MACE), and 
hospitalization for heart failure (non-MACE) using standardized definitions.  Any clinical 
endpoints that meet SAE criteria will be reported as SAEs.  


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11.7. 
Assessment of Lipid Endpoints 
11.7.1. 
Lipid Parameters 
Basic fasting lipid samples will be collected during Screening (Visits S1 and S3) and at the 
4 double-blind treatment visits (Visits T1, T2, T3, and T4).  Lipid assessments will be performed 
as follows: 
• Calculated TC, LDL-C, HDL-C, non-HDL-C, and TG.  
− If TG exceeds 400 mg/dL (4.5 mmol/L) or LDL-C is ≤50 mg/dL (1.3 mmol/L), 
direct measure of LDL-C will be conducted. 
Additional fasting lipids and other biomarkers, including apoB and hs-CRP, will be collected at 
Visits T1 and T4. 
11.7.2. 
Clinical Safety Laboratory Tests 
Clinical Safety laboratory samples will be collected Screening (Visit S1) and at the 
4 double-blind treatment visits (Visits T1, T2, T3, and T4).  
Blood draws for lipids (and glucose) must meet the criteria below.  If these criteria have not been 
met, these blood samples will NOT be collected.  If these criteria can be met by rescheduling 
clinic visit to occur within 3 days, these blood samples will be collected at the rescheduled clinic 
visit only.  
• Blood samples will be drawn after a minimum 10-hour fast (water is allowed)  
Patients are encouraged to be in a seated position during the blood collection.  Clinical laboratory 
parameters and tests will include those listed in Table 4.  Collection schedule and instructions are 
provided in the Clinical Laboratory Manual.  A description of the sample collection, storage, and 
shipping as well as monitoring and management of abnormal laboratories are described in 
Section 11.1.6. 
When ECG, vital signs, and laboratory samples are to be collected at the same time point, ECG 
and vital sign measurements will precede laboratory sample collection.  
Table 4: 
Clinical Laboratory Parameters (Lipids) and Cardiometabolic Biomarkers 
Clinical Laboratory Test  
Clinical Laboratory Test 
Basic Lipid Parameters 
Other Parameters 
• 
Total cholesterol (TC) 
• 
Calculated low-density lipoprotein cholesterol 
(LDL-C)  
• 
High-density lipoprotein cholesterol (HDL-C) 
• 
Non-high-density lipoprotein cholesterol (non-
HDL-C) 
• 
Triglycerides (TG) 
• 
High-sensitivity C-reactive protein (hs-CRP) 
• 
apoB 


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12. 
STATISTICS 
12.1. 
General Considerations 
The statistical analyses described in this section will be performed as further outlined in a 
separate Statistical Analysis Plan (SAP).  The SAP will supersede the protocol in the event of 
any differences between the two documents in the plans for data analysis, and the protocol will 
be amended, if needed.  The SAP will be included as an appendix in the clinical study report for 
this protocol. 
12.2. 
Determination of Sample Size 
The primary efficacy endpoint for this study is the percent change from baseline to Week 12 in 
LDL-C.   
The sample size of 150 randomized patients in the bempedoic acid 180 mg group and 
75 randomized patients in the placebo group is expected to provide more than 95% power to 
detect a difference of 15% in the percent change from baseline to Week 12 in calculated LDL-C 
between the bempedoic acid treatment group and the placebo group.  This calculation is based on 
a 2-sided t-test at the 5% level of significance and a common standard deviation of 15 %.  The 
sample size of 150 randomized patients in the bempedoic acid 180 mg group and 75 randomized 
patients in the placebo group gives a total study sample size of 225.  
12.3. 
Analysis Populations 
The Full Analysis Set (FAS), used for all of the efficacy analyses, is defined as all randomized 
patients.  The FAS is also known as the intention-to-treat (ITT) set of patients.  Patients in the 
FAS will be included in their randomized treatment group, regardless of their actual treatment.  
The Safety Population (SP), used for all of the safety summaries, is defined as all randomized 
patients who received at least 1 dose of study medication.  Patients in the SP will be included in 
the treatment group that they actually received, regardless of their randomized treatment.  
12.4. 
Disposition, Demographics, and Baseline Characteristics 
Disposition, including reason for withdrawal from the IMP or study, will be summarized by 
treatment group.  Demographic information and patient characteristics including, but not limited 
to, gender, race, age, and baseline vital signs will also be summarized by treatment group. 
12.5. 
Primary Efficacy Analysis 
The primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C.   
Baseline LDL-C is defined as the mean of the values from Week -1 (Visit S3) and predose 
Day 1/Week 0 (Visit T1).  The primary efficacy endpoint will be analyzed using analysis of 
covariance (ANCOVA), with treatment group as a factor and baseline LDL-C as a covariate.  
The ANCOVA will be performed using the FAS, with patients included in their randomized 
treatment group regardless of the treatment they actually received.  The details of the ANCOVA 
model and options to correct for unequal variances and group size will be described in the SAP. 


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Missing data for the primary endpoint will be imputed using a multiple imputation method that 
accounts for treatment adherence.  A pattern mixture model (PMM) will be used to specify 
different imputation strategies depending on whether the patient is still on study treatment.  
Imputed datasets will be analyzed using ANCOVA with treatment as a factor and baseline 
LDL-C as a covariate.  Approximately 200 imputed datasets will be created, with results from 
the analysis of each imputed dataset combined using Rubin’s method.  The least squares mean 
(LSM) and standard error (SE) will be provided for both treatment groups, along with the 
placebo-corrected LSM, its 95% confidence interval (CI), and associated p-value.  A 
confirmatory analysis using observed data only will also be performed for the primary endpoint. 
12.6. 
Secondary and Tertiary Efficacy Endpoints 
Secondary efficacy endpoints are also of interest for this study, in terms of controlling the overall 
Type I error rate.  A gatekeeping or stepdown approach will be used to test the primary efficacy 
endpoint and then specific secondary efficacy endpoints sequentially in order to preserve the 
study-wise Type I error rate.  The sequence for the stepdown procedure in this study is as 
follows: 
1. Test the primary efficacy endpoint: percent change from baseline to Week 12 in LDL-C  
2. Test the percent change from baseline to Week 12 in non-HDL-C 
3. Test the percent change from baseline to Week 12 in TC 
4. Test the percent change from baseline to Week 12 in apoB 
5. Test the percent change from baseline to Week 12 in hs-CRP  
In this hierarchical testing structure, each hypothesis is tested at a significance level of 0.05 
2-sided.  Statistical significance at each step is required in order to test the next hypothesis.  If 
the primary efficacy endpoint meets the criteria for statistical significance, then the percent 
change from baseline to Week 12 in non-HDL-C will be tested; and so forth. 
For the remaining secondary efficacy endpoints (percent change from baseline to Week 12 in TG 
and HDL-C) and the tertiary efficacy endpoints, a significance level of 0.05 will be used; given 
the large number of remaining endpoints, the p-values for those endpoints will be considered 
descriptive. 
In general, change or percent change in lipid parameters at a given time point will be analyzed 
using a similar ANCOVA model for the primary endpoint with treatment group as a factor and 
the relevant baseline as the covariate.   
Baseline for non-HDL-C, HDL-C, TC, and TG is defined as the mean of the values from 
Week -1 (Visit S3) and predose Day 1/Week 0 (Visit T1).  Baseline for apoB and hs-CRP is 
defined as the predose Day 1/Week 0 (Visit T1) value.   
Each ANCOVA will be performed using the FAS, with patients included in their randomized 
treatment group regardless of the treatment they actually received.  Same imputation method 
described for the primary endpoint will be used for the secondary endpoints included in the 
stepdown testing procedure, while only observed data analysis will be used for other secondary 
and tertiary endpoints.  For each lipid parameter at each time point, the LSM and SE will be 


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provided for both treatment groups, along with the placebo-corrected LSM, its 95% CI and 
associated p-value.  
The ANCOVA assumption of normality will be assessed.  If non-normality of the data is found 
at any time point for any parameter, either the data will be transformed so that it is normally 
distributed or a nonparametric test will be considered instead of the planned ANCOVA. 
12.7. 
Safety Endpoints 
The summarization of AEs will include only TEAEs.  TEAEs and SAEs will be summarized by 
SOC, severity, and relationship to study drug for each treatment group.  These AE summaries 
will include cumulative incidence (percent of patients experiencing the AE) and patient-year 
adjusted incidence rates.  If appropriate, absolute and relative risk differences will be calculated 
using both cumulative incidence and incidence rates.  Deaths, withdrawal from study treatment 
due to AEs, and withdrawal from the study due to AEs will each be summarized by treatment 
group. 
Clinical safety laboratories, including hematology, blood chemistry, HbA1C, fasting glucose, and 
urinalysis; PE findings; vital signs; ECG readings; and weight will be summarized by the value 
and by change from baseline in the value (where appropriate) at each postbaseline time point. 
12.7.1. 
Hepatic Safety 
For liver-associated enzymes and TB, the number and percent of patients with abnormal values 
for ALT, AST, and TB will be summarized.  Hy’s law criteria (≥3 × ULN for either ALT or 
AST, with accompanying TB >2 × ULN [≥2 × ULN conjugated/direct]\bilirubin will be used in 
patients with Gilbert’s Disease]) in the absence of other known causes will also be applied to the 
data; any potential Hy’s law cases will be listed separately. 
12.7.2. 
Musculoskeletal Safety 
AEs of muscle-related symptoms will be summarized by treatment group.  In addition, the 
number and percent of patients with abnormal CK values will be summarized.  
12.7.3. 
Diabetes and Hyperglycemia 
Cases of worsening and new onset of diabetes will be recorded as AEs and will be summarized 
using the appropriate SOC.  These events will be summarized by severity and relationship to 
study drug for each treatment group. 
12.7.4. 
Renal Safety 
Baseline eGFR and values of CK will be summarized by treatment group and by baseline eGFR 
categories.  Shift tables of eGFR category from baseline over the study will be provided by 
treatment group.  Finally, muscle-related AEs will be summarized by treatment group and by 
baseline eGFR category. 


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12.7.5. 
Neurocognitive Events 
Neurocognitive events will be identified and evaluated by routine safety monitoring of PE 
findings and AEs.  Summarization of neurocognitive events will occur using prespecified 
MedDRA terms and will be performed by treatment group.  
12.7.6. 
Clinical endpoints 
Clinical endpoints using standardized definitions will be adjudicated by an independent blinded 
expert CEC for all ongoing Phase 3 studies in the bempedoic acid program.  Investigator-
reported clinical endpoints and adjudicated clinical endpoints will be summarized by event type 
and treatment group.  Additional details regarding the clinical endpoints and their definitions will 
be included in CEC Charter. 


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13. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The Sponsor (or its authorized representative) has the obligation to follow this study closely to 
ensure that the study is conducted in accordance with the protocol, International Conference on 
Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, national and international 
regulatory requirements, and the current Declaration of Helsinki throughout its duration by 
means of personal visits to the investigator’s facilities and other communications.  
These visits will be conducted to evaluate the progress of the study, verify the rights and 
well-being of the patients are protected, and verify the reported clinical study data are accurate, 
complete, and verifiable from source documents.  This includes review of ICDs, results of tests 
performed as a requirement for participation in this study, and any other medical records 
(eg, laboratory reports, clinic notes, study drug dispensing log, pharmacy records, patient sign-in 
sheets, patient-completed questionnaires, telephone logs, ECGs) required to confirm information 
contained in the eCRFs. 
The monitoring strategy for the study foresees a risk-based monitoring approach, in line with the 
relevant Food and Drug Administration (FDA) and European Medicines Agency (EMA) 
recommendations, and will be described in details by the study-specific risk-based-monitoring 
plan. 
A monitoring visit should include a review of the essential clinical study documents (regulatory 
documents, case report forms, medical records and source documents, drug disposition records, 
patient informed consent forms, etc) as well as discussion on the conduct of the study with the 
investigator and staff. 
The monitor should conduct these visits as frequently as appropriate for the clinical study.  The 
investigator and staff should be available during these visits for discussion of the conduct of the 
study as well as to facilitate the review of the clinical study records and resolve/document any 
discrepancies found during the visit.  
All monitoring activities will be reported and archived.  In addition, monitoring visits will be 
documented at the clinical site by signature and date on the study-specific monitoring log. 
13.1. 
Audits and Inspections 
Representatives of the Sponsor or its authorized clinical quality assurance group may visit a 
clinical site at any time during the study to conduct an audit of the study in compliance with 
regulatory guidelines and company policy.  These audits will require access to all study records, 
including source documents, for inspection and comparison with the eCRFs.  Patient privacy 
must be respected.  The investigator and clinical site personnel are responsible for being present 
and available for consultation during routinely scheduled site audit visits conducted by the 
Sponsor or its authorized representative.  
The clinical study may also be inspected by the FDA or EMA (or other regulatory authority) to 
verify that the study was conducted in accordance with protocol requirements, as well as the 
applicable regulations and guidelines. 


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In the event the investigator is contacted by regulatory authorities who wish to conduct an 
inspection of the clinical site, the investigator will promptly notify the Sponsor of all such 
requests and will promptly forward a copy of all such inspection reports 


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14. 
QUALITY CONTROL AND QUALITY ASSURANCE 
To ensure compliance with GCP and all applicable regulatory requirements, the 
Sponsor/designee may conduct a quality assurance audit.  Please see Section 13.1 for more 
details regarding the audit process. 


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15. 
ETHICS 
15.1. 
Institutional Review Board/Independent Ethics Committee Approval 
Before initiation of the study, the investigator must obtain approval or favorable opinion of the 
research protocol, ICD, and any material related to patient recruitment from an IRB or IEC.  For 
locations participating within the US, the IRB must comply with the provisions specified in 
21 Code of Federal Regulations (CFR) Part 56, ICH and GCP guidelines, and applicable 
pertinent state and federal requirements.  For locations participating outside of the US, the IRB 
or IEC must comply with the applicable requirements of each participating location, including 
ICH and GCP guidelines, except where a waiver is applicable. 
IRBs and IECs must be constituted according to the applicable laws.  It is the responsibility of 
each clinical site to submit the protocol, IB, patient informed consent, patient recruitment 
materials (if applicable), and other documentation as required by the IRB or IEC for review and 
approval.  A copy of the written approval must be provided to the Sponsor.  
The documentation should clearly mention the approval/favorable opinion of the protocol, the 
patient informed consent form, and patient recruitment materials (if applicable), including 
respective version dates.  The written approval and a list of the voting members, their titles or 
occupations, and their institutional affiliations must be obtained from the IRBs or IECs and 
provided to the Sponsor prior to the release of clinical study supplies to the clinical site and 
commencement of the study.  If any member of the IRB or IEC has direct participation in this 
study, written notification regarding his or her abstinence from voting must also be obtained. 
Clinical sites must adhere to all requirements stipulated by their respective IRB or IEC.  This 
includes notification to the IRB or IEC regarding: protocol amendments, updates to the ICD, 
recruitment materials intended for viewing by patients, aggregate safety reports required by 
regulatory competent authorities, serious and unexpected AEs, reports and updates regarding the 
ongoing review of the study at intervals specified by the respective IRB or IEC, and submission 
of final study reports and summaries to the IRB or IEC. 
It is the responsibility of each clinical site to submit information to the appropriate IRB or EC for 
annual review and annual re-approval. 
The investigator must promptly inform their IRB or IEC of all SAEs or other safety information 
reported from the patient or the Sponsor. 
15.2. 
Ethical Conduct of Study 
The Sponsor personnel, when signing the protocol, attest that the clinical study protocol was 
subject to critical review and has been approved by the Sponsor (Appendix 2).   
The investigator agrees, when signing the protocol, to conduct the study in accordance with 
ethical principles that have their origin in the current revision of the Declaration of Helsinki and 
are consistent with ICH/GCP, applicable regulatory requirements, and policies and procedures as 
outlined by the ethical requirements for IRB or IEC review and ICDs. 
The investigator agrees to allow monitoring and auditing of all essential clinical study documents 
by the Sponsor or its authorized representatives and inspection by the FDA, EMA, or other 


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appropriate regulatory authorities.  Monitoring and auditing visits by the Sponsor or authorized 
designee will be scheduled with the appropriate staff at mutually agreeable times periodically 
throughout the study. 
The investigator will assure proper implementation and conduct of the study, including those 
study-related duties delegated to other appropriately qualified individuals.  The investigator will 
assure that study staff cooperates with monitoring and audits, and will demonstrate due diligence 
in recruiting and screening study patients.  The investigator must sign and return to the Sponsor 
the “Investigator’s Signature” page (see Appendix 3) and provide a copy of current curriculum 
vitae.  For this study and all studies conducted under an Investigational New Drug (IND) 
application, the investigator must sign and return a completed Form FDA 1572 “Statement of 
Investigator” to the Sponsor (or designee).  For European Union (EU) investigators, equivalent 
information contained within the FDA 1572 form may be requested unless a waiver has been 
requested and received by the Sponsor from the FDA. 
15.3. 
Written Informed Consent 
The principal investigator(s) at each center will ensure that the patient is given full and adequate 
oral and written information about the nature, purpose, possible risk and benefit of the study.  
Patients must also be notified that they are free to discontinue from the study at any time.  The 
patient should be given the opportunity to ask questions and allowed time to consider the 
information provided. 
The patient’s signed and dated informed consent must be obtained before conducting any study 
procedures. 
The principal investigator(s) must maintain the original, signed ICD.  A copy of the signed ICD 
must be given to the patient. 
15.4. 
Patient Confidentiality 
The names and identities of all research patients will be kept in strict confidence and will not 
appear on eCRFs or other records provided to or retained by the Sponsor (or the Sponsor’s 
authorized representative).  If a patient’s name appears on any document, it must be redacted and 
replaced with the patient identifier before a copy of the document is supplied to the Sponsor or 
Sponsor’s authorized representative.  The ICD must include appropriate statements explaining 
that patient data will be confidential and what actions will be taken to ensure patient 
confidentiality. 
Any other confidentiality requirements specified by the site, IRB or IEC, or national or local 
regulations will be adhered to and detailed appropriately in the ICD. 


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16. 
DATA HANDLING AND RECORDKEEPING 
16.1. 
Inspection of Records 
Applicable regulations require the Sponsor (or the Sponsor’s authorized representative) to 
inspect all documents and records to be maintained by the investigator, including but not limited 
to, medical records (office, clinic, or hospital) for the patients in this study.  These regulations 
also allow the Sponsor’s records to be inspected by authorized representatives of the regulatory 
agencies.  The investigator will permit study-related monitoring, audits, IRB or IEC review, and 
regulatory inspections by providing direct access to source data/documents.  Direct access 
includes permission to examine, analyze, verify, and reproduce any records and reports that are 
important to the evaluation of a clinical study. 
16.2. 
Retention of Records 
In compliance with the ICH/GCP guidelines, the investigator/Institution agrees to retain and 
maintain all study records that support the data collected from each patient, as well as all study 
documents as specified in ICH/GCP, Section 8 Essential Documents for the Conduct of a 
Clinical Trial.  The investigator agrees to contact the Sponsor before destroying or relocating any 
study documentation and is expected to take measures to prevent accidental or premature 
destruction of these documents.  
If the investigator retires, relocates, or for other reasons withdraws from the responsibility of 
keeping the study records, custody must be transferred to a person who will accept responsibility.  
The Sponsor must be contacted in writing regarding the name and address of the new person 
responsible as well as the disposition of document storage.  Under no circumstances shall the 
investigator relocate or dispose of any study documents before having obtained written approval 
from the Sponsor. 
Essential records (including eCRFs, source documents, study drug disposition records, signed 
patient ICDs, AE reports, and other regulatory documents) as required by the applicable 
regulations, must be maintained for 2 years after a marketing application is approved for the drug 
for the indication for which it is being investigated; or, if no application is to be filed or if the 
application is not approved for such indication, until 2 years after formal discontinuation of 
clinical development of the investigational product. 
It is the responsibility of the Sponsor to inform the investigator/Institution as to when these 
documents no longer need to be retained. 
16.3. 
Case Report Forms and Study Records 
Access to eCRFs will be provided to the clinical site.  As part of the responsibilities assumed by 
participating in the study, the investigator agrees to maintain adequate case histories for the 
patients treated as part of the research under this protocol.  The investigator agrees to maintain 
accurate source documentation and eCRFs as part of the case histories.  
Study records are comprised of source documents, eCRFs, and all other administrative 
documents (eg, IRB or IEC correspondence, clinical study materials and supplies shipment 


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manifests, monitoring logs, and correspondence).  A study-specific binder will be provided with 
instructions for the maintenance of study records. 
Source documentation is defined as any handwritten or computer-generated document that 
contains medical information or test results that have been collected for or in support of the 
protocol specifications (eg, laboratory reports, clinic notes, study drug disposition log, pharmacy 
records, patient sign-in sheets, patient completed questionnaires, telephone logs, x-rays, and 
ECGs).  All draft, preliminary, and pre/final iterations of a final report are also considered to be 
source documents (eg, faxed and hard copy of laboratory reports, faxed and hard copy of initial 
results, and final report).  
The investigator agrees to allow direct access to all essential clinical study documents for the 
purpose of monitoring and/or auditing by the Sponsor or its authorized representatives and 
inspection by the appropriate regulatory authorities. 
Data reflecting the patient’s participation with the study drug under investigation are to be 
reported to the Sponsor.  The data are to be recorded on the eCRFs and/or other media provided 
or approved by the Sponsor.  
A completed eCRF must be submitted for each patient who receives study drug, regardless of 
duration.  All supportive documentation submitted with the eCRF, such as laboratory or hospital 
records, should be clearly identified with the study and patient number.  Any personal 
information, including patient name, should be removed or rendered illegible to preserve 
individual confidentiality.  The eCRF should not be used as a source document unless otherwise 
specified by the Sponsor.  
Neither the Sponsor nor a service provider contracted to analyze data and complete the study 
report is permitted to interpret a blank answer; therefore, all fields should be completed.  All 
requested information must be entered on the eCRFs.  If an item is not available or is not 
applicable, this fact should be indicated as not available (N/A) or not done (N/D); do not leave a 
field blank.  
Each set of completed eCRFs must be signed and dated by the investigator acknowledging 
review and that the data are accurate and complete.  The completed database is to be returned to 
the Sponsor as soon as practical after completion by the mechanism prescribed for the protocol. 
It is essential that all dates appearing on the Sponsor’s patient data collection forms for 
laboratory tests, cultures, etc, be the dates on which the specimens were obtained or the 
procedures performed.  The eCRFs will be electronically signed by the investigator and dated as 
verification of the accuracy of the recorded data.  All data collection forms should be completed 
within a timely manner according to the CRF completion guidelines following the evaluation. 


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17. 
ADMINISTRATIVE CONSIDERATIONS 
17.1. 
Investigators 
Investigators must agree to the responsibilities and obligations listed below, as specified by the 
appropriate FDA/EMA regulatory requirements or ICH/GCP guidelines: 
• Agree to conduct the study in accordance with the relevant current protocol 
• Agree to personally conduct or supervise the described investigation(s) 
• Agree to inform any patients, or persons used as controls, that the study drugs are 
being used for investigational purposes and ensure that the requirements relating to 
obtaining informed consent and IRB/IEC review and approval are met  
• Agree to report adverse experiences that occur during the course of the 
investigation(s)  
• Read and understand the information in the IB, including the potential risks and side 
effects of the study drug 
• Ensure that all associates, colleagues, and employees assisting in the conduct of the 
study are informed about their obligations in meeting the above commitments 
• Maintain adequate and accurate records and make those records available for 
inspection  
• Ensure that an appropriate IRB/IEC will be responsible for the initial and continuing 
review and approval of the clinical investigation 
• Agree to promptly report to the IRB/IEC all changes in the research activity and all 
unanticipated problems involving risks to patients or others 
• Agree to not make changes in the research without IRB/IEC approval, except where 
necessary to eliminate apparent hazards to patients 
• Comply with all other requirements regarding the obligations of clinical investigators 
and all other pertinent requirements. 
• Refer also to: 
− FDA Regulations Related to GCP and Clinical Trials: 
http://www.fda.gov/oc/gcp/regulations.html 
− Guidance and Information Sheets on GCP in FDA-Regulated Clinical Trials: 
http://www.fda.gov/oc/gcp/guidance.html 
− Guidance for IRBs and Clinical Investigators: 
http://www.fda.gov/oc/ohrt/irbs/default.htm 
− DIRECTIVE 2001/20/EC:  
http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf 


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− Guidance for Industry – E6 Good Clinical Practice: Consolidated Guidance: 
http://www.fda.gov/cder/guidance/959fnl.pdf 
17.2. 
Study Administrative Structure 
Investigational medicinal product supply chain details can be found in the pharmacy manual. 
Central Laboratory: 
 
 
 
Randomization, IWRS, Statistical Analysis, Study Management and Monitoring, Data 
Management, Medical and Safety Services including Medical Monitoring (see Medical and 
Safety Services below), Programming, and Medical Writing: 
 
 
Medical and Safety Services: 
 
  
 
17.3. 
Amendments 
Changes to the research covered by this protocol must be implemented by formal protocol 
amendment.  All amendments to the protocol must be initiated by the Sponsor and signed and 
dated by the investigator.  Protocol amendments must not be implemented without prior IRB or 
IEC approval.  Documentation of amendment approval by the investigator and IRB or IEC must 
be provided to the Sponsor or its authorized representative.  When the change(s) involve only 
logistic or administrative aspects of the study, the IRB or IEC only needs to be notified.  
During the course of the study, in situations where a departure from the protocol is unavoidable, 
the investigator will contact the Medical Monitor.  Except in emergency situations, this contact 
should be made before implementing any departure from the protocol.  In all cases, contact with 
the Medical Monitor must be made as soon as possible to discuss the situation and agree on an 
appropriate course of action.  The data recorded on the eCRF and source documents will reflect 
any departure from the protocol and the source documents will describe the departure and the 
circumstances requiring it. 
17.4. 
Financial Disclosure 
Prior to the start of the study, investigators will release sufficient and accurate financial 
information that permits the Sponsor to demonstrate that an investigator and all study relevant 


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assigned personnel have no personal or professional financial incentive regarding the future 
approval or disapproval of the study drug such that his or her research might be biased by such 
incentive. 


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18. 
PUBLICATION AND DISCLOSURE POLICY 
It is understood by the investigator that the information and data included in this protocol may be 
disclosed to and used by the investigator’s staff and associates as may be necessary to conduct 
this clinical study. 
All information derived from this clinical study will be used by the Sponsor (or designee) and 
therefore, may be disclosed by the Sponsor (or designee) as required to other clinical 
investigators, to the FDA, EMA, and to other government agencies, or in connection with 
intellectual property filings or publications.  In order to allow for the use of the information 
derived from this clinical study, it is understood by the investigator that there is an obligation to 
provide the Sponsor with complete test results and all data from this clinical study.  The 
investigator agrees to maintain this information in confidence, to use the information only to 
conduct the study, and to use the information for no other purpose without the Sponsor’s prior 
written consent (or as otherwise may be permitted pursuant to a written agreement with the 
Sponsor or its designee). 
The results of the study will be reported in a clinical study report prepared by the Sponsor (or 
designee), which will contain eCRF data from all clinical sites that conducted the study. 
The Sponsor shall have the right to publish data from the study without approval from the 
investigator.  Manuscript(s) and abstract(s) may only be prepared through cooperation between 
the Sponsor (or designee) and the study investigator(s).  If an investigator wishes to publish 
information from the study, a copy of the manuscript must be provided to the Sponsor for review 
in accordance with the provisions of such investigator’s written agreement with the Sponsor (or 
designee) before submission for publication or presentation.  If requested by the Sponsor in 
writing, the investigator will withhold such publication in accordance with the provisions of such 
agreement. 


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Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
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Page 84 of 144 
19. 
LIST OF REFERENCES 
1. Sharrett AR, Ballantyne CM, Coady SA, Heiss G, Sorlie PD, Catellier D, et al. 
Atherosclerosis Risk in Communities Study Group. Coronary heart disease prediction 
from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I 
and B, and HDL density subfractions. The Atherosclerosis Risk in Communities (ARIC) 
Study. Circulation. 2001;104:1108-13. 
2. World Health Organization (WHO) Fact Sheet No 317 Updated January 2015. 
3. Nichols M, Townsend N, Scarborough P, Rayner M. Cardiovascular disease in Europe 
2014: epidemiological update. Eur Heart J. 2014; 35:2950-9. 
4. Mozffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al, for the 
writing group Members. Heart Disease and Stroke Statistics—2015 Update. A Report 
from the American Heart Association. Circ. 2015;131:e29-322. 
5. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merc CN, Blum CB, Eckel RH, et al. 
2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic 
cardiovascular risk in adults: a report of the American College of Cardiology/American 
Heart Association Task Force on Practice Guidelines. Circulation. 2014 
Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a 
6. Kathiresan S, Melander O, Anevski D, Guiducci C, Burtt NP, Roos C, et al. 
Polymorphisms associated with cholesterol and risk of cardiovascular events. New Engl 
J Med. 2008:358;12:1240-9. 
7. Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, et al. Cholesterol 
Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering 
of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised 
trials. Lancet. 2010;376:1670-81. 
8. Robinson JG, Smith B, Maheshwari N, Schrott H. Pleiotropic effects of statins: benefit 
beyond cholesterol reduction: A meta-regression analysis. J Am Coll Cardiol. 2005 
Nov 15;46(10):1855-62. Epub 2005 Oct 24. 
9. Stamler J, Wentworth D, Neaton J. Is relationship between serum cholesterol and risk for 
premature death from coronary heart disease continuous and graded? JAMA. Nov 28 
1986;256(20):2823-8. 
10. Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, et al, for the 
Pravastatin or Atorvastatin Evaluation and Infection Therapy–Thrombolysis in 
Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with 
statins after acute coronary syndromes. New Engl J Med. 2004;350:1495-504. 
11. Jacobson TA for the NLA Task Force on Statin Safety - 2014 update. J Clin Lipidol. 
2014;8:S1-4.  
12. Cannon CP, Blazing MA, Guiglian RP, McCagg A, White JA, Theroux P, et al, for the 
IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary. 
N Engl J Med. 2015;372(25):2387-97. 


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Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
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13. Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 
2003:289:1681-90. 
14. EZETIMIBE – ezetimibe tablet; Dublin, Ireland: Par Pharmaceuticals 2016 
15. Food and Drug Administration (2012). FDA announces safety changes in labeling for 
some cholesterol-lowering drugs [Press release]. Retrieved from 
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm293623.htm  
16. Dietschy JM, Turley SD. Cholesterol metabolism in the brain. Curr Opin Lipidol. 
2001(12):105-12. 
17. Dietschy JM, Turley SD. Cholesterol metabolism in the central nervous system during 
early development and in the mature animal. J Lipid Res. 2004(45):1375-97. 
18. Goedeke L, Fernandez-Hernando C. microRNAs: A connection between cholesterol 
metabolism and neurodegeneration. Neurobiol Dis. 2014(72):48-53. 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 86 of 144 
20. 
APPENDICES 
Appendix 1: Schedule of Events (Patient Visit Schedule) 
Appendix 2: Sponsor’s Signature 
Appendix 3: Investigator’s Signature 
Appendix 4: Summary of Changes in Amendment 1 
Appendix 5: Summary of Changes in Amendment 2 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 87 of 144 
APPENDIX 1. SCHEDULE OF EVENTS (PATIENT VISIT SCHEDULE) 
Visit 
S11 
S2 
S3 
T1 
T2 
T3 
T42 
Week 
-5 
-4 
-1 
0 
4 
8 
12/EOS 
Procedure 
Day 
-35 
±7 days 
Day 
-28 ± 3 
Day 
-7 ± 3 
Day 1 
Day 
29 ± 3 
Day 
57 ± 3 
Day 
85 ± 3 
Informed Consent 
X 
 
 
 
 
 
 
Enrollment Criteria 
X 
X 
X 
X 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
Concomitant\Prohibited 
Medications 
X 
X 
X 
X 
X 
X 
X 
Adverse Event Recording 
 
X 
X 
X 
X 
X 
X 
Physical Exam 
 
X 
 
 
 
 
X 
Weight3 
X 
 
 
X3 
 
 
X 
Height/BMI 
X 
 
 
 
 
 
 
12-Lead ECG4 
 
X 
 
 
 
 
X 
Vital Signs5 
X 
X 
X 
X 
X 
X 
X 
Serology6 
 
X 
 
 
 
 
 
Serum Pregnancy/FSH 7 
X 
 
 
 
 
 
 
Urine Pregnancy7  
 
 
 
X 
 
 
 
TSH 
X 
 
 
 
 
 
 
Clinical Safety Labs8 
X 
 
X 
X 
X 
X 
X 
Basic Fasting Lipids9 
X 
 
X 
X 
X 
X 
X 
Special Fasting Lipids and 
Other Biomarkers10 
 
 
 
X 
 
 
X 
HbA1C 
X 
 
 
X 
 
 
X 
PK sample (prior to IMP 
dosing) 
 
 
 
 
X 
X 
X 
Diet and exercise counseling 
X 
X 
X 
X 
X 
X 
X 
Randomization 
 
 
 
X 
 
 
 
Single Blind/Ezetimibe Drug 
Dispensing 
 
X 
 
X11 
 
 
 
Double Blind Drug Dispensing 
 
 
 
X 
 
 
 
Drug Return12  
 
 
X 
X 
X 
X 
X 
 


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Clinical Study Protocol 1002-048 
Amendment 2, 10 February 2017 
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BMI = body mass index; ECG = electrocardiogram; FSH = follicle-stimulating hormone, HbA1C = hepatitis B surface 
antigen; PK = pharmacokinetics; TSH = thyroid-stimulating hormone. 
1 An optional visit approximately 1 week later MAY be completed if patient fails to meet TG criterion.  If this 
optional visit is completed, the repeat TG value will be used to determine eligibility.  
2 All procedures will be completed at end of study or early termination. 
3 Body weight will be measured in the morning while fasting, using consistent scales, after voiding, and without 
shoes and outerwear (eg, coats). 
4 Single 12-lead ECG will be collected prior to any blood sample collection. 
5 Vital signs will include SBP, DBP, and HR, and will be collected prior to any blood sample collection.  Patient will 
rest for 5 minutes prior to assessments. 
6 Serology for Hep B antigen, Hep C antibody. 
7 FSH completed in appropriate postmenopausal women only; pregnancy test completed in non-postmenopausal 
women only. 
8 Clinical safety labs include hematology, blood chemistry, and urinalysis.  Coagulation panel at S1 only, unless 
receiving anticoagulants (then test at T1 and repeat 3-5 days after starting IMP).  For patients not taking ezetimibe 
at S1, measure blood chemistry and CK only at S3. 
9 Basic fasting lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides. 
10 Includes apoB and hs-CRP. 
11 Ezetimibe dispensing only. 
12 Record unused IMP and ezetimibe and reissue study drug bottles at Visits T1 (ezetimibe only), T2, and T3.  
Perform final drug count at Visit T4.  


Bempedoic acid 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
Amendment 2, 10 February 2017 
APPENDIX 2. SPONSOR'S SIGNATURE 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 
Multi center Study to Evaluate the Efficacy and Safety of Bempedoic Acid 
(ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with 
Elevated LDL-C on Low Dose or Less Than Low Dose Statins 
Study Number: 
1002-048 
This clinical study protocol was subject to critical review and has been approved by the Sponsor. 
The following personnel contributed to writing and/or approving this protocol: 
SiOO 
 
 
 
 
Confidential 
Page 89 of 144 
Date: 8 (Y\ctr 2-01+


Bempedoic acid 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
Amendment 2, 10 February 20 17 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 
Multicenter Study to Evaluate the Efficacy and Safety ofBempedoic Acid 
(ETC-1 002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with 
Elevated LDL-C on Low Dose or Less Than Low Dose Statins 
Study Number: 
1002-048 
This clinical study protocol was subject to critical review and has been approved by the Sponsor. 
The following personnel contributed to writing and/or approving this protocol: 
 
Signed: 
 
 
Confidential 
Date: tJL/ !Yltft r ;;Lo[l 
Page 90 of 144 


Bempedoic acid 
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Clinical Study Protocol 1002-048 
Amendment 2, 10 February 2017  
Confidential 
Page 91 of 144 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 
Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid 
(ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with 
Elevated LDL-C on Low Dose or Less Than Low Dose Statins 
Study Number: 
1002-048 
This clinical study protocol was subject to critical review and has been approved by the Sponsor.  
The following personnel contributed to writing and/or approving this protocol: 
Signed:
  
 
 
3/4/2017


Bempedoic acid 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
Amendment 2, 10 February 2017 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 
Multicenter Study to Evaluate the Efficacy and Safety ofBempedoic Acid 
(ETC-1 002) 1 80 mg/day as Add-on to Ezetimibe Therapy in Patients with 
Elevated LDL-C on Low Dose or Less Than Low Dose Statins 
Study N urn ber: 
1002-048 
This clinical study protocol was subject to critical review and has been approved by the Sponsor. 
The following personnel contributed to writing and/or approving this protocol: 
Signed: 
 
 
 
 
Confidential 
Date: :jo4,/ 9-
Page 92 of 144 


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Clinical Study Protocol 1002-048 
Amendment 2, 10 February 2017 
Confidential 
Page 93 of 144 
APPENDIX 3. INVESTIGATOR’S SIGNATURE 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 
Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid 
(ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with 
Elevated LDL-C on Low Dose or Less Than Low Dose Statins 
Study Number: 
1002-048 
I have read the protocol described above.  I agree to comply with all applicable regulations and 
to conduct the study as described in the protocol.  
Signed: 
Date: 
Name and Credentials: 
Title:  
Affiliation:  
Address:  
Phone Number:  


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Clinical Study Protocol 1002-048 
Amendment 2, 10 February 2017 
Confidential 
Page 94 of 144 
APPENDIX 4. SUMMARY OF CHANGES AMENDMENT 1 
SUMMARY OF CHANGES 
CLINICAL STUDY PROTOCOL 
Study Number: 
1002-048 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, 
Parallel Group, Multicenter Study to Evaluate the 
Efficacy and Safety of Bempedoic Acid (ETC-1002) 
180 mg/day as Add-on to Ezetimibe Therapy in Patients 
with Elevated LDL-C  
Protocol Version Incorporating 
Current Summary of Changes: 
Amendment 1:  18 January 2017 
Preceding Protocol Version: 
Original Protocol:  22 September 2016 
Investigational Product Name: 
ETC-1002 
Conventions used in this Summary of Changes Document 
1. The text immediately preceding and following a change to the protocol is included for
each change in order to provide the reviewer with a reference point to identify the change
in the protocol.
2. All locations (ie, section numbers and/or header text) refer to the current protocol
version, which incorporates the items specified in this Summary of Changes document.
3. The original text is from the preceding protocol version.
4. In the “New Text”, all substantive text added to the protocol is bolded and italicized.
5. In the “New Text”, text deleted from the protocol is indicated in strikethrough font.
Summary and Justification of Changes 
The protocol was amended for the following: 
•
Added a line for Amendment 1 version and date to reflect amendment version details.
•
Revised inclusion #5 under Section 7.1, Subject Inclusion Criteria, to revise the
definition of abstinence to reflect guidance from the Heads of Medicines Agency.
•
Added the revised inclusion criteria #5 to the Synopsis
•
Changed names and titles of Sponsor representatives providing signage on the
protocol amendment


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Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 95 of 144 
CHANGE 1 REVISION OF TITLE PAGE VERSION INFORMATION 
Location: 
Title Page: Version 
Original Text: 
 
Version 
Date 
 
 
Original Protocol: 
22 September 2016 
 
New Text: 
 
Version 
Date 
 
 
Amendment 1: 
18 January 2017 
 
 
CHANGE 2 REVISION OF INCLUSION CRITERIA  
Location: 
Synopsis, Diagnosis and criteria for patient eligibility, Inclusion Criteria 
New Text: 
5. Men and nonpregnant, nonlactating women.  Women must be either 
• Naturally postmenopausal defined as ≥1 year without menses and  
− ≥55 years, or  
− <55 years with follicle-stimulating hormone (FSH) ≥40.0 IU/L, or 
• Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal 
ligation, or 
• Women of childbearing potential willing to use 1 acceptable method of birth 
control including: 
− oral, implantable, or topical birth control medications 
− placement of an intrauterine device with or without hormones 
− barrier methods including condom or occlusive cap with spermicidal foam or 
spermicidal jelly  
− vasectomized male partner who is the sole partner for this patient  
− True abstinence:  When this is in line with the preferred and usual lifestyle of 
the subject.  (Periodic abstinence [eg, calendar, ovulation, symptothermal, 
postovulation methods], declaration of abstinence for the duration of a trial, 
and withdrawal are not acceptable methods of contraception). 
Note:  There are no protocol-specific birth control requirements for men with partners 
who are able to become pregnant. 


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Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 96 of 144 
Location: 
Section 7.1, Subject Inclusion Criteria 
Original Text: 
5. Men and nonpregnant, nonlactating women.  Women must be either 
• Naturally postmenopausal defined as ≥1 year without menses and  
− ≥55 years, or  
− <55 years with follicle-stimulating hormone (FSH) ≥40.0 IU/L, or 
• Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal 
ligation, or 
• Women of childbearing potential willing to use 1 acceptable method of birth control 
including: 
− Oral, implantable, or topical birth control medications 
− placement of an intrauterine device with or without hormones 
− barrier methods including condom or occlusive cap with spermicidal foam or 
spermicidal jelly  
− vasectomized male partner who is the sole partner for this patient  
− true abstinence (not including periodic abstinence such as calendar, ovulation, 
symptothermal, postovulation methods, or withdrawal 
Note:  There are no protocol-specific birth control requirements for men with partners 
who are able to become pregnant. 
New Text: 
5. Men and nonpregnant, nonlactating women.  Women must be either 
• Naturally postmenopausal defined as ≥1 year without menses and  
− ≥55 years, or  
− <55 years with follicle-stimulating hormone (FSH) ≥40.0 IU/L, or 
• Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal 
ligation, or 
• Women of childbearing potential willing to use 1 acceptable method of birth control 
including: 
− oral, implantable, or topical birth control medications 
− placement of an intrauterine device with or without hormones 
− barrier methods including condom or occlusive cap with spermicidal foam or 
spermicidal jelly  
− vasectomized male partner who is the sole partner for this patient  


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Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 97 of 144 
− true abstinence (not including periodic abstinence such as calendar, ovulation, 
symptothermal, postovulation methods, or withdrawalTrue abstinence:  When 
this is in line with the preferred and usual lifestyle of the subject.  (Periodic 
abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], 
declaration of abstinence for the duration of a trial, and withdrawal are not 
acceptable methods of contraception). 
Note:  There are no protocol-specific birth control requirements for men with partners 
who are able to become pregnant. 
 
CHANGE 3 REMOVED FINAL DATE 
Location:  
Appendix 2:  Final Date, all pages within Appendix 2 
Original text: 
Final Date: 
22 September 2016 
New text: 
Final Date: 
22 September 2016 
 


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Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
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Page 98 of 144 
CHANGE 4 CHANGE IN SPONSOR REPRESENTATIVES PROVIDING PROTOCOL 
SIGNAGE 
Location:  
Appendix 2:  Sponsor Signatures 
Original text: 
Signed:  
Date:  
 
Sharon Watling, PharmD 
Senior Director, Clinical Development 
Esperion Therapeutics, Inc. 
 
 
New text: 
Signed:  
Date:  
 
Sharon Watling, PharmD LeAnne Bloedon, MS, RD 
Senior Director, Clinical Development 
Esperion Therapeutics, Inc. 
 
 
 
Original text: 
Signed:  
Date:  
 
Mary McGowan, MD 
Chief Medical Officer 
Esperion Therapeutics, Inc. 
 
 
New text: 
Signed:  
Date:  
 
Mary McGowan, Ricardo Dent-Acosta, MD 
Chief Medical Officer Vice President, Clinical 
Development 
Esperion Therapeutics, Inc. 
 
 
 


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Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 99 of 144 
APPENDIX 5. SUMMARY OF CHANGES AMENDMENT 2 
 
SUMMARY OF CHANGES 
CLINICAL STUDY PROTOCOL 
Study Number: 
1002-048 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, 
Parallel Group, Multicenter Study to Evaluate the 
Efficacy and Safety of Bempedoic Acid (ETC-1002) 
180 mg/day as Add-on to Ezetimibe Therapy in Patients 
with Elevated LDL-C on Low Dose or Less than Low Dose 
Statins 
Protocol Version Incorporating 
Current Summary of Changes: 
Amendment 2:  10 February 2017 
Preceding Protocol Version: 
Amendment 1:  18 January 2017 
Investigational Product Name: 
ETC-1002 
Conventions used in this Summary of Changes Document 
1. The text immediately preceding and following a change to the protocol is included for 
each change in order to provide the reviewer with a reference point to identify the change 
in the protocol. 
2. All locations (ie, section numbers and/or header text) refer to the current protocol 
version, which incorporates the items specified in this Summary of Changes document. 
3. The original text is from the preceding protocol version. 
4. In the “New Text”, all substantive text added to the protocol is bolded and italicized. 
5. In the “New Text”, text deleted from the protocol is indicated in strikethrough font. 
Summary and Justification of Changes 
The protocol was amended for the following: 
• Added a line for Amendment 2 version and date to reflect amendment version details. 
• Changed protocol title to more accurately reflect the study population. 
• Updated bempedoic acid mechanism of action. 
• Revised inclusion criteria #3 to allow enrollment of ezetimibe naïve patients with 
LDL-C ≥120 mg/dL at Week -5, Visit S1; included LDL mmol/L as well as mg/dL 
values. 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 100 of 144 
• Added injectables as an allowable form of hormonal contraception and requirement 
that women use 2 rather than 1 form of acceptable contraception based on a 
regulatory request received through the Voluntary Harmonization Procedure in 
Europe (no new data led to this decision). 
• Clarified time period during which subjects should not intend to become pregnant 
(starting at minimum on Day 1 and continuing for at least 30 days after last dose of 
study drug).  
• Added exclusion criteria to cover previous intolerance to ezetimibe. 
• Added exclusion criteria for patients who have enrolled in a study of an experimental 
siRNA inhibitor of PCSK9. 
• Excluded use of CETP inhibitors. 
• Changed exclusion time period for mipomersen to 6 months. 
• Removed the allowance to rescreen if LDL-C criteria at S1 is not met.  
• Extended screening an additional 4 weeks if needed to adjust background therapy. 
• Removed collection of PK at Day 0; specified collection of PK samples prior to IMP 
dosing. 
• Added requirement to S3 (Week -1) Visit that LDL-C ≥70 mg/dL. 
• Added chemistry panel and CK to Visit S3 (Week -1) given inclusion of ezetimibe 
naïve patients. 
• Removed optional genetic sampling. 
• Removed instructions to reserve samples. 
• Corrected windowing of allowable and prohibited medications to be consistent 
between entry criteria and protocol body. 
• Removed lipids other than LDL-C as a specified tertiary endpoint. 
• Removed manufacturing contact details (will be in pharmacy manual). 
• Added text on the administration of study supplied ezetimibe, including assessment of 
relationship of AEs to both IMP and ezetimibe. 
• Changed monitoring of CK for asymptomatic patients per FDA request. 
• Revised safety endpoints.  
• Revised statistical sections to clarify level of significance standard deviation, methods 
for imputation of missing data, and application of ANCOVA model for primary and 
secondary endpoints. 
• Made administrative changes made throughout protocol where required to correct 
inconsistencies, add clarification, or correct errors. 
 


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Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 101 of 144 
CHANGE 1 REVISION OF PROTOCOL TITLE AND TITLE PAGE VERSION 
INFORMATION 
Location: 
Title page 
Original Text: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to 
Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to 
Ezetimibe Therapy in Patients with Elevated LDL-C  
 
 
Version 
Date 
 
 
Amendment 1: 
18 January 2017 
 
New Text: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to 
Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to 
Ezetimibe Therapy in Patients with Elevated LDL-C on Low Dose or Less than Low Dose 
Statins 
 
 
Version 
Date 
 
 
Original Protocol 
22 September 2016 
 
 
Amendment 1: 
18 January2017 
 
 
Amendment 2: 
10 February 2017 
 
 
CHANGE 2 SYNOPSIS REVISIONS 
Location: 
Section 2, Synopsis  
(Only changes specific to Synopsis are noted here.  Changes that apply to both Synopsis and 
CSR body sections are noted under ‘Location:’) 
Original Text: 
Secondary: 
• 
To evaluate the effect of 12-week treatment with bempedoic acid 180 mg/day versus placebo 
when added to ezetimibe therapy on  
− 
non-high-density lipoprotein cholesterol (non-HDL-C), 
− 
total cholesterol (TC), 
− 
apolipoprotein B (apoB), and  
− 
high-sensitivity C-reactive protein (hs-CRP)  


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Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
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Page 102 of 144 
• 
To evaluate the effect of 12-week treatment with bempedoic acid 180 mg/day versus placebo on 
triglycerides (TG) and high-density lipoprotein cholesterol (HDL-C) 
• 
To evaluate 12-week safety and tolerability of bempedoic acid 180 mg/day compared with 
placebo  
Tertiary: 
• 
To evaluate the effects of 4- and 8-week treatment with bempedoic acid 180 mg/day versus 
placebo when added to ezetimibe therapy on  
− 
LDL-C 
− 
Non-HDL-C 
− 
TC 
− 
TG 
− 
HDL-C 
New Text: 
Secondary: 
• 
To evaluate the effect of 12-week treatment with bempedoic acid 180 mg/day versus placebo 
when added to ezetimibe therapy on  
− 
non-high-density lipoprotein cholesterol (non-HDL-C), 
− 
total cholesterol (TC), 
− 
apolipoprotein B (apoB), and  
− 
high-sensitivity C-reactive protein (hs-CRP)  
• 
To evaluate the effect of 12-week treatment with bempedoic acid 180 mg/day versus placebo on 
triglycerides (TG) and high-density lipoprotein cholesterol (HDL-C) when added to ezetimibe 
• 
To evaluate 12-week safety and tolerability of bempedoic acid 180 mg/day compared with 
placebo when added to ezetimibe 
Tertiary: 
• 
To evaluate the effects of 4- and 8-week treatment with bempedoic acid 180 mg/day versus 
placebo when added to ezetimibe therapy at 4 and 8 weeks on the following parameters: 
− 
LDL-C 
− 
Non-HDL-C 
− 
TC 
− 
TG 
− 
HDL-C 
 
Original Text: 
Study Design:  
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter study that 
will be conducted in North America and Europe.  Patients on maximally tolerated background lipid-
modifying therapy (LMT) that includes ezetimibe and a maximally tolerated statin that is low dose or less 
than low dose (including patients unable to tolerate a statin at any dose) and who require additional LDL 
lowering will be eligible for screening.  Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors 
are not allowed.  Screening (Visit S1) will begin approximately 5 weeks prior to randomization, but can 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
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be extended for an additional 4 weeks, if needed, to adjust background medical therapy or for other 
reasons as specified in the protocol.  Eligible patients will return at Week -4 (Visit S2) to discontinue their 
current supply of ezetimibe 10 mg and begin treatment with study-supplied ezetimibe 10 mg and single-
blind placebo.  Patients will continue their other background LMT for the duration of the trial.  Patients 
will return to the clinical site at Week -1 (Visit S3) for assessment of adverse events (AEs) and adherence 
with study medication (study-supplied ezetimibe and single-blind placebo) and to complete lipid 
assessments.  Approximately 225 eligible patients will be randomized 2:1 on Day 1 (Visit T1) to receive 
either bempedoic acid 180 mg (N = 150) or placebo (N = 75) for 12 weeks.  Randomized patients will 
return for clinic visits at Week 4 (Visit T2), Week 8 (Visit T3), and Week 12 (Visit T4). 
New Text: 
Study Design:  
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter study that 
will be conducted in North America and Europe.  Patients on maximally tolerated background lipid-
modifying therapy (LMT) that includes ezetimibe and a maximally tolerated statin that is low dose or less 
than low dose statin therapy (including patients unable to tolerate a statin at any dose) and who require 
additional LDL lowering will be eligible for screening.  Proprotein convertase subtilisin/kexin type 9 
(PCSK9) inhibitors are not allowed.  Screening (Visit S1) will begin approximately 5 weeks prior to 
randomization, but can be extended for an additional 4 weeks, if needed, to adjust background medical 
therapy or for other reasons as specified in the protocol.  Eligible patients will return at Week -4 
(Visit S2) to discontinue their current supply of ezetimibe 10 mg and begin treatment with study-supplied 
ezetimibe 10 mg and single-blind placebo.  Patients already taking ezetimibe 10 mg will switch to study-
supplied ezetimibe 10 mg.  Patients will continue their other background lipid-modifying therapy (LMT) 
for the duration of the trial.  Patients will return to the clinical site at Week -1 (Visit S3) for assessment of 
adverse events (AEs) and adherence with study medication (study-supplied ezetimibe and single-blind 
placebo) and to complete lipid assessments.  Approximately 225 eligible patients will be randomized 2:1 
on Day 1 (Visit T1) to receive either bempedoic acid 180 mg (N = 150) or placebo (N = 75) for 12 weeks.  
Randomized patients will return for clinic visits at Week 4 (Visit T2), Week 8 (Visit T3), and Week 12 
(Visit T4). 
Original Text: 
Statistical Methods: 
Sample Size 
The primary efficacy endpoint for this study is the percent change from baseline to Week 12 in LDL-C.   
The sample size of 150 randomized patients in the bempedoic acid 180 mg group and 75 randomized 
patients in the placebo group is expected to provide more than 95% power to detect a difference of 15% 
in the percent change from baseline to Week 12 in calculated LDL-C between the bempedoic acid 
treatment group and the placebo group.  This calculation is based on a 2-sided t-test at the 5% level of 
significance and a common standard deviation of 15 mg/dL.  The sample size of 150 randomized patients 
in the bempedoic acid 180 mg group and 75 randomized patients in the placebo group gives a total study 
sample size of 225.  
New Text: 
Statistical Methods: 
Sample Size 
The primary efficacy endpoint for this study is the percent change from baseline to Week 12 in LDL-C.   
The sample size of 150 randomized patients in the bempedoic acid 180 mg group and 75 randomized 
patients in the placebo group is expected to provide more than 95% power to detect a difference of 15% 
in the percent change from baseline to Week 12 in calculated LDL-C between the bempedoic acid 


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treatment group and the placebo group.  This calculation is based on a 2-sided t-test at the 5% level of 
significance and a common standard deviation of 15% mg/dL.  The sample size of 150 randomized 
patients in the bempedoic acid 180 mg group and 75 randomized patients in the placebo group gives a 
total study sample size of 225.  
Original Text: 
Primary Efficacy Analysis 
The primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C.  Baseline is 
defined as the mean of the values from Week -1 (Visit S3) and predose Day 1/Week 0 (Visit T1).  The 
primary efficacy endpoint will be analyzed using analysis of covariance (ANCOVA), with treatment 
group as a factor and baseline LDL-C as a covariate.  The ANCOVA will be performed using the FAS, 
with patients included in their randomized treatment group regardless of the treatment they actually 
received.  Two methods for data handling will be used:  the first is observed case data only, while the 
second will involve specification of the missing data mechanism using a pattern mixture model (PMM).  
The primary analysis will be that from the PMM, while the observed case analysis will be used as 
confirmatory.  The PMM will be used to specify different imputation strategies depending on whether or 
not the patient is still on study treatment.  Imputed datasets will be analyzed using ANCOVA with 
treatment as a factor and baseline LDL-C as a covariate.  Approximately 100 imputed datasets will be 
created, with results from the analysis of each imputed dataset combined using Rubin’s method.  For each 
ANCOVA (observed case; imputation via PMM), the least squares mean (LSM) and standard error (SE) 
will be provided for both treatment groups, along with the placebo-corrected LSM, its 95% confidence 
interval (CI), and associated p-value. 
Secondary and Tertiary Efficacy Analysis 
For the remaining secondary efficacy endpoints (percent change from baseline to Week 12 in TG and 
HDL-C) and the tertiary efficacy endpoints, a significance level of 0.05 will be used; given the large 
number of remaining endpoints, the p-values for those endpoints will be considered descriptive. 
A significance level of 0.05 will be used; given the large number of tertiary endpoints, the p-values for 
those endpoints will be considered descriptive. 
Change from baseline to Week 12 in LDL-C; and percent change from baseline to Week 12 in HDL-C, 
non-HDL-C, TG, TC, apoB, and hs-CRP will each be analyzed using ANCOVA with treatment group as 
a factor and the relevant baseline as the covariate.  Baseline for non-HDL-C, HDL-C, TC, and TG are 
defined as the mean of the values from Week -1 (Visit S3) and predose Day 1/Week 0 (Visit T1), while 
baseline for apoB and hs-CRP is defined as the predose Day 1/Week 0 (Visit T1) value.  Each ANCOVA 
will be performed using the FAS, with patients included in their randomized treatment group regardless of 
the treatment they actually received.  Only observed case data will be included (no imputation will be 
performed for missing data).  For each lipid parameter at each time point, the LSM and SE will be 
provided for both treatment groups, along with the placebo-corrected LSM, its 95% CI and associated 
p-value.  
For all continuous efficacy endpoints (percent change from baseline and absolute change from baseline in 
LDL-C, HDL-C, non-HDL-C, TC, TG, apoB, and hs-CRP; to Weeks 4, 8, and 12, as appropriate), the 
ANCOVA assumption of normality will be assessed.  If non-normality of the data is found at any time 
point for any parameter, either the data will be transformed so that it is normally distributed or a 
nonparametric test will be used instead of the planned ANCOVA. 
Safety Analyses 
No statistical analyses will be performed on any of the safety data in this study.  
The summarization of AEs will include only treatment-emergent AEs (TEAEs).  TEAEs and SAEs will 
be summarized by system organ class (SOC), severity, and relationship to study drug for each treatment 
group.  These AE summaries will include cumulative incidence (percent of patients experiencing the AE) 
and patient-year adjusted incidence rates.  If appropriate, absolute and relative risk differences will be 


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calculated using both cumulative incidence and incidence rates.  Deaths, withdrawal from study treatment 
due to AEs, and withdrawal from the study due to AEs will each be summarized by treatment group. 
Clinical safety laboratories, including hematology, blood chemistry, HbA1C, glucose, and urinalysis; PE 
findings; vital signs; ECG readings; and weight will be summarized by the value and by change from 
baseline in the value (where appropriate) at each postbaseline time point. 
New Text: 
Primary Efficacy Analysis 
The primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C.  Baseline is 
defined as the mean of the values from Week -1 (Visit S3) and predose Day 1/Week 0 (Visit T1).  The 
primary efficacy endpoint will be analyzed using analysis of covariance (ANCOVA), with treatment 
group as a factor and baseline LDL-C as a covariate.  The ANCOVA will be performed using the FAS, 
with patients included in their randomized treatment group regardless of the treatment they actually 
received.  Missing data will be imputed using multiple imputation method that accounts for treatment 
adherence via Two methods for data handling will be used:  the first is observed case data only, while the 
second will involve specification of the missing data mechanism using a pattern mixture model (PMM).  
The primary analysis will be that from the PMM, while the observed case analysis will be used as 
confirmatory.  The PMM will be used to specify different imputation strategies depending on whether or 
not the patient is still on study treatment.  Imputed datasets will be analyzed using ANCOVA with 
treatment as a factor and baseline LDL-C as a covariate.  Approximately 200100 imputed datasets will be 
created, with results from the analysis of each imputed dataset combined using Rubin’s method.  For final 
results, each ANCOVA (observed case; imputation via PMM), the least squares mean (LSM) and 
standard error (SE) will be provided for both treatment groups, along with the placebo-corrected LSM, its 
95% confidence interval (CI), and associated p-value. 
Secondary and Tertiary Efficacy Analysis 
For the remaining secondary efficacy endpoints (percent change from baseline to Week 12 in TG and 
HDL-C) and the tertiary efficacy endpoints, a significance level of 0.05 will be used; given the large 
number of remaining endpoints, the p-values for those endpoints will be considered descriptive. 
A significance level of 0.05 will be used; given the large number of tertiary endpoints, the p-values for 
those endpoints will be considered descriptive. 
Absolute and percent cChange from baseline to specific time points for Week 12 in LDL-C; and percent 
change from baseline to Week 12 in HDL-C, non-HDL-C, TG, TC, apoB, lipid parameters and hs-CRP 
will each be analyzed similarly using ANCOVA with treatment group as a factor and the relevant 
baseline as the covariate.  Baseline for non-HDL-C, HDL-C, TC, and TG are defined as the mean of the 
values from Week -1 (Visit S3) and predose Day 1/Week 0 (Visit T1), while baseline for apoB and hs-
CRP is defined as the predose Day 1/Week 0 (Visit T1) value.  Each ANCOVA will be performed using 
the FAS, with patients included in their randomized treatment group regardless of the treatment they 
actually received.  Only observed case data will be included (no imputation will be performed for missing 
data).  For each lipid parameter at each time point, the LSM and SE will be provided for both treatment 
groups, along with the placebo-corrected LSM, its 95% CI and associated p-value.  
For all continuous efficacy endpoints (percent change from baseline and absolute change from baseline in 
LDL-C, HDL-C, non-HDL-C, TC, TG, apoB, and hs-CRP; to Weeks 4, 8, and 12, as appropriate), the 
ANCOVA assumption of normality will be assessed.  If non-normality of the data is found at any time 
point for any parameter, either the data will be transformed so that it is normally distributed or a 
nonparametric test will be used instead of the planned ANCOVA. 
Safety Analyses 
No statistical analyses will be performed on any of the safety data in this study.  


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The summarization of AEs will include only treatment-emergent AEs (TEAEs).  TEAEs and SAEs will 
be summarized by system organ class (SOC), severity, and relationship to study drug for each treatment 
group.  These AE summaries will include cumulative incidence (percent of patients experiencing the AE) 
and patient-year adjusted incidence rates.  If appropriate, absolute and relative risk differences will be 
calculated using both cumulative incidence and incidence rates.  Deaths, withdrawal from study treatment 
due to AEs, and withdrawal from the study due to AEs will each be summarized by treatment group. 
Clinical safety laboratories, including hematology, blood chemistry, HbA1C, fasting glucose, and 
urinalysis; PE findings; vital signs; ECG readings; and weight will be summarized by the value and by 
change from baseline in the value (where appropriate) at each postbaseline time point. 
Original Text: 
PK and Other biomarkers 
PK plasma concentrations will be summarized at predose at Week 0 (Visit T1), Week 4 (Visit T2), 
Week 8 (Visit T3), and Week 12 (Visit T4). 
New Text: 
PK and Other biomarkers 
PK plasma concentrations for ETC 1002 and its metabolite ESP15228 will be summarized at predose at 
Week 0 (Visit T1), Week 4 (Visit T2), Week 8 (Visit T3), and Week 12 (Visit T4). 
 
CHANGE 3 INTRODUCTION REVISIONS 
Location: 
Section 4.1, Lipid-Regulating Drugs and Cardiovascular Disease 
Original Text: 
Patients with elevated LDL-C on ezetimibe who are only able to tolerate low dose or less than 
low dose of statins alone (or demonstrate an inability to tolerate a statin) or in combination with 
other lipid-modifying therapies and unable to meet their LDL-C treatment goals are the target 
population for this study. 
New Text: 
The target population for this study includes pPatients with elevated LDL-C on ezetimibe who 
are only able to tolerate low dose or less than low dose of statins alone (or demonstrate an 
(including those not taking a statin due to inability to tolerate a statin) or in combination with 
other lipid-modifying therapies and unable to meet their (in some cases also includes ezetimibe) 
and who require additional LDL-C loweringtreatment goals are the target population for this 
study. 
 
CHANGE 4 INTRODUCTION REVISIONS 
Location: 
Section 4.2.1, Mechanism of Action 


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Original Text: 
An important differentiating feature of bempedoic acid is that it does not inhibit cholesterol 
synthesis in skeletal muscle.  In addition to preliminary data suggesting that only minor amounts 
of bempedoic acid enter skeletal muscle (<5% of systemic exposure), skeletal muscle does not 
express the enzyme required to activate bempedoic acid to ETC-1002-CoA and inhibit ACL.  
Therefore, bempedoic acid is not anticipated to mediate the adverse effects associated with 
inhibition of biological intermediates within the cholesterol biosynthesis pathway in skeletal 
muscle. 
New Text: 
An important differentiating feature of bempedoic acid is that, unlike statins, it does not inhibit 
cholesterol synthesis in skeletal muscle.  The enzyme required to convert bempedoic acid to 
ETC-1002-CoA is not present in skeletal muscle.In addition to preliminary data suggesting that 
only minor amounts of bempedoic acid enter skeletal muscle (<5% of systemic exposure), 
skeletal muscle does not express the enzyme required to activate bempedoic acid to ETC-1002-
CoA and inhibit ACL.  Therefore, bempedoic acid is not anticipated to mediate the adverse 
effects associated with inhibition of biological intermediates within the cholesterol biosynthesis 
pathway in skeletal muscle; however, the safety of bempedoic acid and its metabolites 
regarding human skeletal muscle is not yet established. 
 
CHANGE 5 ENDPOINT REVISIONS 
Location: 
Section 5.4.3, Tertiary Efficacy Endpoints and Section 5.4.4, Safety Endpoints 
Original Text: 
Tertiary endpoints include assessments of percent change and absolute change from baseline in 
lipid levels at the additional time points of Week 4 (T2) and Week 8 (T3). 
1. Percent change from baseline to Weeks 4 and 8 in  
a. LDL-C 
b. Non-HDL-C 
c. TC 
d. TG 
e. HDL-C 
2. Absolute change from baseline to Weeks 4, 8, and 12 in 
a. LDL-C 
b. Non-HDL-C 
c. TC 
d. TG 
e. HDL-C 


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5.4.4 Safety Endpoints 
No statistical analyses will be performed on any of the safety data in this study.  The descriptive 
summaries of AE data, endpoints used to evaluate hepatic, musculoskeletal, 
diabetes/hyperglycemic, renal, neurocognitive safety, and defined clinical endpoints are 
described in Section 12.7. 
New Text: 
Tertiary endpoints include assessments of percent change and absolute change from baseline in 
lipid levels at the additional time points of Week 4 (T2) and Week 8 (T3). 
1. Percent change from baseline to Weeks 4 and 8 in  
a. LDL-C 
b. Non-HDL-C 
c. TC 
d. TG 
e. HDL-C 
2. Absolute change from baseline to Weeks 4, 8, and 12 in LDL-C 
a. LDL-C 
b. Non-HDL-C 
c. TC 
d. TG 
e. HDL-C 
5.4.4 Safety Endpoints 
a. Subject incidence to TEAE 
b. Safety laboratory values and vital signs 
c. ECG findings 
d. Cardiovascular event rates 
No statistical analyses will be performed on any of the safety data in this study.  The descriptive 
summaries of AE data, endpoints used to evaluate hepatic, musculoskeletal, 
diabetes/hyperglycemic, renal, neurocognitive safety, and defined clinical endpoints are 
described in Section 12.7. 
 


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CHANGE 6 STUDY DESIGN REVISIONS 
Location: 
Section 6.1, Overall Study Design 
Original Text: 
Screening Week -5 (Visit S1) will begin approximately 5 weeks prior to randomization, but can 
be extended for an additional 4 weeks, if needed, to adjust background medical therapy or for 
other reasons as specified in the protocol.  Eligible patients will return to the clinical site at 
Week -4 (Visit S2) to begin treatment with ezetimibe 10 mg and single-blind placebo. 
New Text: 
Screening Week -5 (Visit S1) will begin approximately 5 weeks prior to randomization, but can 
be extended for an additional 4 weeks, if needed, to adjust background medical therapy or for 
other reasons as specified in the protocol.  Eligible patients will return to the clinical site at 
Week -4 (Visit S2) to begin treatment with study supplied ezetimibe 10 mg and single-blind 
placebo.  Patients having their own supply of ezetimibe will switch to study-supplied ezetimibe 
at this visit. 
 
CHANGE 7 INCLUSION CRITERIA REVISIONS 
Location: 
Synopsis; Section 7.1, Subject Inclusion Criteria #3 
Original Text: 
3. Fasting LDL-C (minimum of 10 hours) at Week -5 (Visit S1) ≥100 mg/dL (2.6 mmol/L) 
on stable background LMT (greater than or equal to 4 weeks prior to screening) requiring 
further LDL-C lowering. 
Note:  LDL-C may be repeated 1 time with the screening period extended up to 4 weeks.  
For those patients who have a repeat LDL-C, the mean of the first value and the repeat 
value will be used to determine eligibility.  
New Text: 
3. Fasting LDL-C (minimum of 10 hours) calculated LDL-C at Week -5 (Visit S1) as 
defined by ezetimibe use at screening: 
• For patients who have been taking ezetimibe 10 mg daily prior to Week -5 
(Visit S1):  Fasting LDL-C ≥100 mg/dL (2.6 mmol/L) on stable background lipid-
modifying therapy (LMT; (greater than or equal to 4 weeks prior to screening) 
requiring further LDL-C lowering. 
• For patients who have not been taking ezetimibe Week -5 (Visit S1):  Fasting 
LDL-C ≥120 mg/dL (3.1 mmol/L) on stable background LMT (greater than or 
equal to 4 weeks prior to screening). 
• All patients must have fasting LDL-C ≥70 mg/dL (1.8 mmol/L) at Week -1 
(Visit S3) 


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Note:  LDL-C may be repeated 1 time with the screening period extended up to 4 weeks.  
For those patients who have a repeat LDL-C, the mean of the first value and the repeat 
value will be used to determine eligibility.  
 
CHANGE 8 INCLUSION CRITERIA REVISIONS 
Location: 
Synopsis; Section 7.1, Subject Inclusion Criteria #4 and #5 
Original Text: 
4. Currently receiving stable (greater than or equal to 4 weeks prior to screening) 
background maximally tolerated LMT that includes ezetimibe 10 mg daily and 
maximally tolerated statin dose that does not exceed low dose statin therapy.  Patients 
must report attempting greater than low dose statin therapy and being unable to tolerate it 
due to an adverse safety effect that started or increased during statin therapy and resolved 
or improved when statin therapy was discontinued or the dose lowered. 
New Text: 
4. Currently receiving stable (greater than or equal to 4 weeks prior to screening) 
background maximally tolerated LMT that includes ezetimibe 10 mg daily and 
maximally tolerated statin dose that does not exceed low dose statin therapy.  Patients 
must report attempting greater than low dose statin therapy and being unable to tolerate it 
due to an adverse safety effect that started or increased during statin therapy and resolved 
or improved when statin therapy was discontinued or the dose lowered. 
Original Text: 
• Women of childbearing potential willing to use 1 acceptable method of birth control 
including: 
− oral, implantable, or topical birth control medications 
− placement of an intrauterine device with or without hormones 
− barrier methods including condom or occlusive cap with spermicidal foam or 
spermicidal jelly 
− vasectomized male partner who is the sole partner for this patient  
− True abstinence:  When this is in line with the preferred and usual lifestyle of the 
subject.  (Periodic abstinence [eg, calendar, ovulation, symptothermal, 
postovulation methods], declaration of abstinence for the duration of a trial, and 
withdrawal are not acceptable methods of contraception). 
Note:  There are no protocol-specific birth control requirements for men with partners 
who are able to become pregnant. 
New Text: 
• Women of childbearing potential willing to use 12 acceptable methods of birth 
control (unless they have agreed to follow the definition of true abstinence).  The 


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minimal requirement for adequate contraception should be started on Day 1, 
continuing during the study period and for at least 30 days after the last dose of 
study drug.  Acceptable methods of birth control include including: 
− oral, implantable, injectable, or topical birth control medications 
− placement of an intrauterine device with or without hormones 
− barrier methods including condom or occlusive cap with spermicidal foam or 
spermicidal jelly vasectomized male partner who is the sole partner for this 
patient  
− True abstinence:  When this is in line with the preferred and usual lifestyle of the 
subject.  (Periodic abstinence [eg, calendar, ovulation, symptothermal, 
postovulation methods], declaration of abstinence for the duration of a trial, and 
withdrawal are not acceptable methods of contraception). 
Note:  There are no protocol-specific birth control requirements for men with partners 
who are able to become pregnant. 
 
CHANGE 9 EXCLUSION CRITERIA REVISIONS 
Location:  
Synopsis; Section 7.2, Subject Exclusion Criteria #2 
Original Text: 
2. Recent history of documented clinically significant cardiovascular disease including, but 
not limited to 
• Within 3 months of screening, myocardial infarction, severe or unstable angina 
pectoris, coronary angioplasty, coronary artery bypass graft, stroke, transient 
ischemic attack, cerebrovascular event, symptomatic carotid artery disease, or 
symptomatic peripheral arterial disease  
• Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) ≥160 mm 
Hg and diastolic blood pressure (DBP) ≥100 mm Hg after sitting quietly for 
5 minutes.  Note: If the initial blood pressure (BP) values meet or exceed the 
specified level, an additional BP assessment may be completed.  If the systolic or the 
diastolic values continue to meet or exceed the threshold, the patient may not 
continue screening.  However, at the discretion of the investigator, the screening 
period may be extended up to 4 weeks to allow for a repeat qualifying BP assessment 
following adjustment of BP medication(s), provided that the patient has been on a 
stable dose of the BP medication for a minimum of 2 weeks prior to randomization 
and the repeat BP measurements do not meet the exclusion criteria 
• Within 3 months of screening, arrhythmia requiring medical intervention 
• Planned revascularization procedures 
• New York Heart Association (NYHA) Class IV heart failure 


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New Text: 
2. Recent history of documented clinically significant cardiovascular disease including, but 
not limited to 
• Within 3 months of screening (Week -5 [Visit S1]) or between screening and 
randomization, myocardial infarction, severe or unstable angina pectoris, coronary 
angioplasty, coronary artery bypass graft, stroke, transient ischemic attack, 
cerebrovascular event, symptomatic carotid artery disease, or symptomatic peripheral 
arterial disease  
• Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) ≥160 mm 
Hg and diastolic blood pressure (DBP) ≥100 mm Hg after sitting quietly for 
5 minutes.  Note: If the initial blood pressure (BP) values meet or exceed the 
specified level, an additional BP assessment may be completed.  If the systolic or the 
diastolic values continue to meet or exceed the threshold, the patient may not 
continue screening.  However, at the discretion of the investigator, the screening 
period may be extended up to 4 weeks to allow for a repeat qualifying BP assessment 
following adjustment of BP medication(s), provided that the patient has been on a 
stable dose of the BP medication for a minimum of 2 weeks prior to randomization 
and the repeat BP measurements do not meet the exclusion criteria 
• Within 3 months of screening (Week -5 [Visit S1]) or between screening and 
randomization visits, arrhythmia requiring medical intervention 
• Planned revascularization procedures 
• New York Heart Association (NYHA) Class IV heart failure 
 
CHANGE10 EXCLUSION CRITERIA REVISIONS 
Location:  
Synopsis; Section 7.2, Subject Exclusion Criteria #15, #17, #21, and #22 
Original Text: 
15. Use of any experimental or investigational drugs within 30 days prior to screening; 
16. Previous enrollment in a bempedoic acid clinical study. 
17. Use of any of the following drugs prior to screening or a plan to use these drugs during 
the study as follows: 
• Within 2 weeks prior to screening 
− Cholestin or red yeast rice-containing products (also known as monascus 
purpureus extract) 
• Within 4 weeks prior to screening 
− Statin doses exceeding those defined as low dose.  Doses exceeding low dose 
statin therapy are defined as an average daily dose of rosuvastatin  greater than 
5 mg, atorvastatin greater than 10 mg, simvastatin greater than 10 mg, lovastatin 


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greater than 20 mg, pravastatin greater than 40 mg, fluvastatin greater than 40 mg, 
or pitavastatin greater than 2 mg. 
• Within 3 months prior to screening:  
− Requirement for mipomersen or lomitapide or apheresis therapy  
− Probenecid or cyclosporine 
• Within 4 months prior to screening 
− Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors 
18. Planned initiation of the following drugs during the clinical trial or changes to the 
following drugs prior to randomization: 
• Hormone replacement (within 6 weeks prior to randomization) 
• Thyroid replacement (within 6 weeks prior to randomization) 
• Diabetes medications (within 4 weeks prior to randomization) 
• Obesity medication (within 3 months prior to randomization) 
19. New or planned dose changes of systemic corticosteroids. 
Note: Stable doses of systemic corticosteroids at screening are allowed (≥4 weeks from 
Visit S1). Topical steroids are allowed. 
20. An employee or contractor of the facility conducting the study, or a family member of the 
principal investigator, co-investigator, or Sponsor. 
21. Pregnant, breastfeeding, or intending to become pregnant 
New Text: 
15. Use of any experimental or investigational drugs within 30 days prior to screening.  
Patients who have enrolled in a study of an experimental small interfering RNA 
(siRNA) inhibitor of PCSK9 are excluded; 
16. Previous enrollment in a bempedoic acid clinical study. 
17. Use of any of the following drugs prior to screening (Week -5, Visit S1) or a plan to use 
these drugs during the study as follows: 
• Within 2 weeks prior to screening 
− Cholestin or red yeast rice-containing products (also known as monascus 
purpureus extract) 
• Within 4 weeks prior to screening 
− Statin doses exceeding those defined as low dose.  Doses exceeding low dose 
statin therapy are defined as an average daily dose of rosuvastatin  greater than 
5 mg, atorvastatin greater than 10 mg, simvastatin greater than 10 mg, lovastatin 
greater than 20 mg, pravastatin greater than 40 mg, fluvastatin greater than 40 mg, 
or pitavastatin greater than 2 mg. 


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• Within 6 weeks prior to screening for patients taking a statin 
− Gemfibrozil is not allowed in patients taking a statin as per co-administration 
instructions defined in the statin label 
• Within 3 months prior to screening:  
− Requirement for mipomersen or lLomitapide or apheresis therapy  
− Probenecid or cyclosporine 
• Within 4 months prior to screening 
− Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors 
• Within 6 months prior to screening 
− Mipomersen 
− Cholesteryl ester transfer protein inhibitor (CETP-I) within the last 2 years 
prior to screening (Week -5, Visit S1) except for evaceptrapib within the last 
3 months to screening (Week -5, Visit S1) 
18. Planned initiation of the following drugs during the clinical trial or changes to the 
following drugs prior to randomization: 
• Hormone replacement (within 6 weeks prior to randomization) 
• Thyroid replacement (within 6 weeks prior to randomization) 
• Diabetes medications (within 4 weeks prior to randomization) 
• Obesity medication (within 4 weeks3 months prior to randomization) 
19. New or planned dose changes of systemic corticosteroids. 
Note: Stable doses of systemic corticosteroids at screening are allowed (≥4 weeks from 
Visit S1). Topical steroids are allowed. 
20. An employee or contractor of the facility conducting the study, or a family member of the 
principal investigator, co-investigator, or Sponsor. 
21. Pregnant, breastfeeding, or intending to become pregnant within 30 days after study 
completion or last dose of study drug. 
22. Previous intolerance to ezetimibe. 
 
CHANGE 11 REMOVED REDUNDANT TEXT 
Location:  
Section 7.3, Patient Lifestyle and Dietary Guidelines 
Original Text: 
Each dose of investigational medicinal product (IMP) is comprised of 1 tablet from 1 bottle that 
will be dispensed at each scheduled clinic visit.  Study drug should be taken once a day (once 


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every 24 hours) at approximately the same time every day and may be taken with or without 
food.  Patients will fast for a minimum of 10 hours prior to collection of all laboratory samples.  
Patients will be counseled to follow a lipid-lowering diet as per local or regional guidelines and 
should be encouraged (as able) to participate in a regular exercise program throughout the study.  
New Text: 
Each dose of investigational medicinal product (IMP) is comprised of 1 tablet from 1 bottle that 
will be dispensed at each scheduled clinic visit.  Study drug should be taken once a day (once 
every 24 hours) at approximately the same time every day and may be taken with or without 
food.  Patients will fast for a minimum of 10 hours prior to collection of all laboratory samples.  
Patients will be counseled to follow a lipid-lowering diet as per local or regional guidelines and 
should be encouraged (as able) to participate in a regular exercise program throughout the study.  
 
CHANGE 12 CONCOMITANT MEDICATIONS REVISIONS 
Location:  
Section 8.4.1, Lipid-Regulating Medications and Supplements 
Original Text: 
Eligible patients will be those currently receiving stable (greater than or equal to 4 weeks prior to 
screening) background maximally tolerated LMT that includes ezetimibe 10 mg daily and 
maximally tolerated statin therapy that does not exceed low dose.  Low dose statin therapy is 
defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, 
lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.  Very low dose 
statin therapy is defined as an average daily dose of rosuvastatin <5 mg, atorvastatin <10 mg, 
simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin <40 mg, or pitavastatin 
<2 mg.  
Patients on ezetimibe and low or very low dose statin or unable to tolerate any statin at any dose 
are eligible.  Patients may continue taking low or very low dose statin therapy throughout the 
study provided that it is stable (greater than or equal to 4 weeks) and well tolerated.  Patients 
unable to take any dose of statins are also eligible provided that statin therapy has been 
attempted.   
PCSK9 inhibitors are not allowed during the study period.   
The ezetimibe and IMP will be study-supplied. 
New Text: 
Eligible patients will be those currently receiving stable (greater than or equal to 4 weeks prior to 
screening, Week -5, Visit S1) background maximally tolerated LMT that includes ezetimibe 
10 mg daily and maximally tolerated statin therapy that does not exceed low dose.  Low dose 
statin therapy is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, 
simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.  
Very low dose statin therapy is defined as an average daily dose of rosuvastatin <5 mg, 


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atorvastatin <10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin 
<40 mg, or pitavastatin <2 mg.  
Patients on ezetimibe and low or very low dose statin or unable to tolerate any statin at any dose 
are eligible.  Patients may continue taking low or very low dose statin therapy throughout the 
study provided that it is stable (greater than or equal to 4 weeks) and well tolerated.  Patients 
unable to take any dose of statins are also eligible provided that statin therapy has been 
attempted, as described above.   
Patients should continue taking their LMT throughout the study. 
PCSK9 inhibitors are not allowed during the study period.   
The ezetimibe and IMP will be study-supplied.  Patients on ezetimibe at Visit S1 will stop 
taking their supply of medication at Visit S2 and begin taking study-supplied ezetimibe. 
 
CHANGE 13 CONCOMITANT MEDICATIONS REVISIONS 
Location:  
Section 8.4.2 Prohibited Medications 
Original Text: 
Patients will not have used the medications (monotherapies or combination therapies) as listed 
below or use these drugs during the study.  
• Cholestin or red yeast rice-containing products (also known as monascus purpureus 
extract) within 2 weeks prior to screening 
• PCSK9-inhibitors within 4 months prior to screening 
• Lomitapide, mipomersen, apheresis therapy within 3 months prior to screening 
New Text 
Patients should not usewill not have used the following medications (monotherapies or 
combination therapies) as listed prior to screening as defined in the exclusion criteria and 
below, or use these drugs at any time during the study.  
• Within 2 weeks prior to screening, Week  5, Visit S1: 
− Cholestin or red yeast rice-containing products (also known as monascus 
purpureus extract) within 2 weeks prior to screening 
• Within 4 weeks prior to screening, Week -5, Visit S1: 
− Statin dose exceeding low dose as defined under inclusion criteria. 
− New or planned dose changes of systemic corticosteroids 
• Within 6 weeks prior to screening, Week -5, Visit S1 for patients taking a statin: 
− Gemfibrozil is not allowed in patients taking a statin as per co-administration 
instructions defined in the statin label 


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• Within 3 months prior to screening, Week -5, Visit S1: 
− Lomitapide or apheresis therapy 
− Probenecid or cyclosporine 
• PCSK9-inhibitors within 4 months prior to screening, Week -5, Visit S1 
• Lomitapide, mipomersen, apheresis therapy within 3 months prior to screening 
• Mipomersen within 6 months prior to screening, Week -5, Visit S1 
• CETP-inhibitors within the last 2 years before screening, Week -5, Visit S1 except 
for evaceptrapib within the last 3 months prior to screening (Week -5, Visit S1) 
• New or planned anti-arrhythmia medication(s) within 3 months to screening 
(Week -5, Visit S1). 
• Any experimental or investigational drugs within 30 days before screening 
(Week -5, Visit S1).  Patients who have enrolled in a study of an experimental 
siRNA inhibitor of PCSK9 are excluded. 
 
CHANGE 14 CONCOMITANT MEDICATIONS REVSIONS 
Location:  
Section 8.4.3, Allowable Medications 
Original Text: 
Other concomitant medications and doses must be stable for 2 weeks prior to screening and, if 
possible, not be adjusted during the study except for reasons of safety.  
The following must be stable for a minimum of 6 weeks prior to randomization: 
• Postmenopausal hormone therapy 
• Thyroid hormone supplements 
• Fibrates 
The following must be stable for a minimum of 4 weeks prior to screening: 
• Hypertriglyceridemia therapy (such as niacin, omega-3 fatty acids) 
• LMT (with the exception of PCSK9-inhibitors and greater than low dose statins 
which are exclusionary) 
• Diabetes medications 
• New or planned dose changes of systemic corticosteroids.  
Note:  Stable doses of systemic corticosteroids at screening are allowed (≥4 weeks 
from Visit S1). Topical steroids are allowed.  


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The following must be stable for a minimum of 3 months prior to screening and, if possible not 
be adjusted during the study except for reasons of safety: 
• Antiobesity medications 
New Text: 
LMT not prohibited are allowed and should remain stable for at least 4 weeks prior to 
screening (Week -5, Visit S1); fibrates (with the exception of gemfibrozil which is exclusionary 
in patients taking a statin) should remain stable for at least 6 weeks prior to screening 
(Week -5, Visit S1).  Use of any of the following medications are allowed if started before the 
randomization visit (Day 1, Visit T1) as defined below and are expected to remain stable 
through completion of the study: 
• Hormone replacement therapy (≥6 weeks before Day 1, Visit T1) 
• Thyroid replacement therapy (≥6 weeks before Day 1, Visit T1) 
• Diabetes medications (≥4 weeks before Day 1, Visit T1) 
• Obesity medications (≥4 weeks before Day 1, Visit T1) 
Other concomitant medications and doses must be stable for 2 weeks prior to screening and, if 
possible, not be adjusted during the study except for reasons of safety.  
The following must be stable for a minimum of 6 weeks prior to randomization: 
• Postmenopausal hormone therapy 
• Thyroid hormone supplements 
• Fibrates 
The following must be stable for a minimum of 4 weeks prior to screening: 
• Hypertriglyceridemia therapy (such as niacin, omega-3 fatty acids) 
• LMT (with the exception of PCSK9-inhibitors and greater than low dose statins 
which are exclusionary) 
• Diabetes medications 
• New or planned dose changes of systemic corticosteroids.  
Note:  Stable doses of systemic corticosteroids at screening are allowed (≥4 weeks 
from Visit S1). Topical steroids are allowed.  
The following must be stable for a minimum of 3 months prior to screening and, if possible not 
be adjusted during the study except for reasons of safety: 
• Antiobesity medications 
 


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CHANGE 15 TREATMENT COMPLIANCE REVISIONS 
Location:  
Section 8.5.2, Placebo Run-in and Treatment Period Adherence 
Original Text: 
At the Week -1 (S3) visit in the placebo and ezetimibe run-in period and at each of the 
subsequent patient visits, designated clinical site staff will assess patients for ezetimibe and IMP 
adherence by counting the number of tablets that are returned as unused and by querying the 
patient with regards to daily intake.  If the patient has not taken all doses of study drug as 
instructed, the patient will be queried for a reason, findings will be documented, and the patient 
will be counseled on the importance of carefully following all dosing instructions.  Factors 
contributing to poor adherence will be determined and, if possible, remedied.  Following 
randomization, patients demonstrating poor adherence will continue to be counseled on the 
importance of carefully following all dosing instructions, but will not be removed from the study.  
Prior to randomization, during the ezetimibe and single blind run-in period, patients with ≤80% 
adherence and/or who experienced a study drug-related AE will not go on to randomization.  
New Text: 
At the Week -1 (S3) visit in the placebo and ezetimibe run-in period and at each of the 
subsequent patient visits, designated clinical site staff will assess patients for ezetimibe and IMP 
adherence by counting the number of tablets that are returned as unused and by querying the 
patient with regards to daily intake.  IfPrior to randomization, during the ezetimibe and single-
blind run-in period, patients with ≤80% adherence to either ezetimibe or single-blind placebo 
and/or who experienced an AE judged at least possibly related to ezetimibe and/or single-blind 
placebo will not go on to randomization. 
After randomization, if the patient has not taken all doses of study drug as instructed, the patient 
will be queried for a reason, findings will be documented, and the patient will be counseled on 
the importance of carefully following all dosing instructions.  Factors contributing to poor 
adherence will be determined and, if possible, remedied.  Following randomization, patients 
demonstrating poor adherence will continue to be counseled on the importance of carefully 
following all dosing instructions, but will not be removed from the study.  Prior to 
randomization, during the ezetimibe and single blind run-in period, patients with ≤80% 
adherence and/or who experienced a study drug-related AE will not go on to randomization.  
 
CHANGE 16 TREATMENT COMPLIANCE REVISIONS 
Location:  
Section 9.1, Investigational Medicinal Product Supply and Control 
Original Text: 
A 35-day supply of single-blind placebo drug will be dispensed one time at Week -4 (Visit S2) 
for the 4-week placebo run-in period of the study.  Double-blind IMP will be dispensed in one 
100-day supply increments (one 100-day supply bottle) to patients by appropriate clinical site 


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personnel at Week 0 (Visit T1), Week 4 (Visit T2), and Week 8 (Visit T3) and Week 12/EOS 
(Visit T4).   
Please see Pharmacy Manual for detailed storage requirements and management instructions. 
New Text: 
A 35-day supply of single-blind placebo drug will be dispensed one time at Week -4 (Visit S2) 
for the 4-week placebo run-in period of the study.  Double-blind IMP will be dispensed in one 
100-day supply increments (one 100-day supply bottle) to patients by appropriate clinical site 
personnel at Week 0 (Visit T1).  Patients will bring their bottle at each subsequent visit for 
tablets to be counted by study personnel.  After tablets have been counted, the same bottle will 
be reissued to patients at Week 4 (Visit T2), and Week 8 (Visit T3) and with the bottle being 
returned to study site at Week 12/EOS for the final count (Visit T4).   
A 30-day supply of open-label ezetimibe 10 mg will be dispensed at Week -4 (Visit S2) for the 
run-in period of the study.  A 90-day supply will be dispensed at Week 0 (Visit T1).  Patients 
will bring their bottle to each subsequent visit for tablets to be counted by study personnel.  
After tablets have been counted, the same bottle will be reissued to patients at Week 4 
(Visit T2) and Week 8 (Visit T3) with the bottle being returned to study site at Week 12/EOS 
for the final count. 
Please see Pharmacy Manual for detailed storage requirements and management instructions. 
 
CHANGE 17 STUDY PROCEDURES REVISIONS 
Location:  
Synopsis; Section 10.1, Informed Consent and all other protocol locations as applicable 
Original Text: 
The patient must be adequately informed of the nature and risks of the study and understand the 
informed consent document (ICD).  No study-related procedure will be performed until the 
patient has been completely informed of the study, has freely consented to take part in the study, 
and has signed and dated an ICD approved by the Sponsor (or designee) and the IRB or IEC.  
Participation in banking of samples for genetic analysis is optional for all patients, and consent 
for this must be documented in the patient’s written informed consent. 
New Text: 
The patient must be adequately informed of the nature and risks of the study and understand the 
informed consent document (ICD).  No study-related procedure will be performed until the 
patient has been completely informed of the study, has freely consented to take part in the study, 
and has signed and dated an ICD approved by the Sponsor (or designee) and the IRB or IEC.  
Participation in banking of samples for genetic analysis is optional for all patients, and consent 
for this must be documented in the patient’s written informed consent. 
 


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CHANGE 18 STUDY PROCEDURES REVISIONS 
Location:  
Section 10.2.1, Screening Week -5 (Visit S1; Days -42 to -35)  
10.2.1 Screening Week -5 (Visit S1; Days -42 to -35) 
The screening period will begin with a screening visit that will occur approximately 5 weeks 
prior to randomization.  At the investigator’s discretion, screening may be extended for an 
additional 4 weeks, if needed, to adjust background medical therapy or for other reasons as 
specified in the protocol.  Visit S1 will allow the investigator to assess the patient’s preliminary 
eligibility.  After the patient provides written informed consent (Section 10.1), the patient will 
undergo the following assessments and procedures at Visit S1: 
New Text: 
10.2.1 Screening Week -5 (Visit S1; Days -42 to -35 to ±7 days) 
The screening period will begin with a screening visit that will occur approximately 5 weeks 
prior to randomization.  At the investigator’s discretion, screening may be extended for an 
additional 4 weeks, if needed, to adjust background medical therapy or for other reasons as 
specified in the protocol.  Visit S1 will allow the investigator to assess the patient’s preliminary 
eligibility.  After the patient provides written informed consent (Section 10.1), the patient will 
undergo the following assessments and procedures at Visit S1: 
Original Text: 
Patients who meet all enrollment criteria that can be assessed at Visit S1 will be instructed to 
continue their background statin for lipid regulation and to maintain consistent diet and exercise 
patterns throughout the study.  They should be instructed to stop taking their personal supply of 
ezetimibe and to take study-supplied ezetimibe.  Patients who fail to meet any entry criterion that 
can be assessed at Visit S1 are considered to be screen failures and are not required to return for 
additional visits (although a patient can be seen at any time for safety reasons). 
An optional visit approximately 1 week later MAY be completed if patient fails to meet a lipid 
entry criterion.  If this optional visit is completed, the mean LDL value will be used to determine 
eligibility. 
Patients who are considered to be screen failures due to not meeting stability requirements for a 
condition or concurrent medication may be considered for rescreening after consultation with the 
Sponsor (or designee).  These patients must be re-consented, re-registered in the IWRS, and will 
have a new patient ID number assigned. 
New Text: 
Patients who meet all enrollment criteria that can be assessed at Visit S1 will be instructed to 
continue their background statinLMT for lipid regulation and to maintain consistent diet and 
exercise patterns throughout the study.  They should be instructed to stop taking their personal 
supply of ezetimibe and to take study-supplied ezetimibe.  Patients who fail to meet any entry 
criterion that can be assessed at Visit S1 are considered to be screen failures and are not required 
to return for additional visits (although a patient can be seen at any time for safety reasons). 


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An optional visit approximately 1 week later MAY be completed if patient fails to meet a lipid 
entry criterion.  If this optional visit is completed, the mean LDL value will be used to determine 
eligibility. 
Patients Under rare circumstances, patient who are considered to be screen failures due to not 
meeting stability requirements for a condition or concurrent medication may bethat is considered 
forto warrant rescreening after consultation with the Sponsor (or designee) may be rescreened.  
These patients must be re-consented, re-registered in the IWRS, and will have a new patient ID 
number assigned. 
 
CHANGE 19 STUDY PROCEDURES REVISIONS 
Location:  
Section 10.2.2, Placebo and Ezetimibe Run in Week -4 (Visit S2; Day -28 to ±3 days) 
Original Text: 
Patients will undergo the following assessments and procedures at Visit S2:  
• Review of all inclusion/exclusion criteria that can be assessed at this time 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs (starting from signing of the informed consent document) 
• Physical examination 
• Electrocardiogram (ECG) 
• Vital signs 
• Serology (including HBsAg, hepatitis C antibody) 
• Conduct diet and exercise counseling 
• Single-blind drug dispensing with instructions − ezetimibe 10 mg and placebo 
• Schedule next visit 
New Text: 
Patients will undergo the following assessments and procedures at Visit S2:  
• Review of all inclusion/exclusion criteria that can be assessed at this time 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints (starting from signing of the 
informed consent document) 
• Physical examination 
• Electrocardiogram (ECG) 
• Vital signs 
• Serology (including HBsAg, hepatitis C antibody) 


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• Conduct diet and exercise counseling 
• Single-blind drug dispensing with instructions − ezetimibe 10 mg and placebo 
• Dispense ezetimibe 10 mg and single-blind placebo with instructions.  If the patient 
is already taking ezetimibe, instruct patient to stop taking their personal supply of 
ezetimibe and to start taking study-supplied ezetimibe 
• Schedule next visit 
 
CHANGE 21 STUDY PROCEDURES REVISIONS 
Location:  
Section 10.2.3 Placebo and Ezetimibe Run-in Week -1 (Visit S3; Day -7 to ±3 days) 
Original Text: 
Patients will undergo the following assessments and procedures at Visit S3: 
• Review of all inclusion/exclusion criteria 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs (starting from signing of the informed consent document) 
• Vital signs 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Conduct diet and exercise counseling 
• Assessment and recording of drug compliance 
• Schedule next visit 
New Text: 
Patients will undergo the following assessments and procedures at Visit S3: 
• Review of all inclusion/exclusion criteria 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints(starting from signing of the 
informed consent document) 
• For patients who were not taking ezetimibe at Week -5, Visit S1, measure CK and 
blood chemistry 
• Vital signs 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Conduct diet and exercise counseling 
• Assessment and recording of drug compliance with both single-blind placebo and 
study-supplied ezetimibe 


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• Schedule next visit 
 
CHANGE 21 STUDY PROCEDURES REVISIONS 
Location:  
Section 10.2.4, Treatment Week 0 (Visit T1; Day 1) 
Original Text: 
Prior to scheduling Visit T1, review the screening and placebo run-in clinical results to evaluate 
whether the patient continues to meet eligibility criteria. 
• If the patient meets eligibility criteria, then schedule Visit T1 and proceed with the 
Visit T1 procedures 
New Text: 
Prior to scheduling Visit T1, review the screening information collected at Visits S1, S2, and 
S3and placebo run-in clinical results to evaluate whether the patient continues to meet eligibility 
criteria. 
• If the patient meets eligibility criteria, then schedule Visit T1 and proceed with the 
Visit T1 procedures 
Original Text: 
Patients will undergo the following assessments and procedures at Visit T1: 
• Review inclusion/exclusion criteria to establish patient eligibility 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs (starting from signing of the informed consent document) 
• Weight 
• Vital signs 
• Urine pregnancy test (for females of childbearing potential) 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Special fasting lipids and other biomarkers (including apoB and hs-CRP) 
• HbA1C 
• Conduct diet and exercise counseling 
• Randomization 
• Double-blind drug dispensing with instructions − bempedoic acid 180 mg and 
matching placebo 
• Ezetimibe dispensing 


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• Drug return and recording of drug compliance 
• Schedule next visit 
New Text: 
Patients will undergo the following assessments and procedures at Visit T1: 
• Review inclusion/exclusion criteria to establish patient eligibility 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints (starting from signing of the 
informed consent document) 
• Weight 
• Vital signs 
• Urine pregnancy test (for females of childbearing potential) 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Special fasting lipids and other biomarkers (including apoB and hs-CRP) 
• HbA1C 
• Conduct diet and exercise counseling 
• Randomization 
• Double-blind drug dispensing with instructions − bempedoic acid 180 mg and 
matching placebo 
• Ezetimibe dispensing 
• Drug return and recording of drug compliance 
• Dispense a new bottle of double-blind IMP and ezetimibe 10 mg 
• Schedule next visit 
 
CHANGE 22 STUDY PROCEDURES REVISIONS 
Location:  
Section 10.2.5, Treatment Week 4 (Visit T2; Day 29 ±3 days) 
Original Text: 
Patients will undergo the following assessments and procedures at Visit T2: 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs (starting from signing of the informed consent document) 
• Vital signs 


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• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Conduct diet and exercise counseling 
• Drug return and recording of drug compliance 
• Schedule next visit 
Note:  If this visit is being conducted at the site for patients who have consented to be followed 
for safety assessments, including basic fasting lipids, after withdrawing from IMP treatment, all 
assessments except for those procedures pertaining to IMP management (IMP dispensing, IMP 
compliance, IMP accountability) should be completed. 
Note:  If this visit is being conducted by telephone contact for patients who have consented to be 
followed by phone for safety assessments after withdrawing from IMP treatment, collect 
information as reported by the patient regarding AEs, concomitant medication, and current health 
status. 
New Text: 
Patients will undergo the following assessments and procedures at Visit T2: 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints(starting from signing of the 
informed consent document) 
• Vital signs 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• PK sample prior to use 
• Conduct diet and exercise counseling 
• Record unused IMP and ezetimibe and reissue study drug bottles Drug return and 
recording of drug compliance 
• Schedule next visit 
Note:  If this visit is being conducted at the site for patients who have consented to be followed 
for safety assessments, including basic fasting lipids, after withdrawing from IMP treatment, all 
assessments except for those procedures pertaining to IMP management (IMP dispensing, IMP 
compliance, IMP accountability) should be completed. 
Note:  If this visit is being conducted by telephone contact for patients who have consented to be 
followed by phone for safety assessments after withdrawing from IMP treatment, collect 
information as reported by the patient regarding AEs, concomitant medication, and current health 
status. 
 


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CHANGE 23 STUDY PROCEDURES REVISIONS 
Location:  
Section 10.2.6, Treatment Week 8 (Visit T3; Day 57 ±3 days) 
Original Text: 
Patients will undergo the following assessments and procedures at Visit T3: 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs (starting from signing of the informed consent document) 
• Vital signs 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Conduct diet and exercise counseling 
• Drug return and recording of drug compliance 
• Schedule next visit 
Note:  If this visit is being conducted at the site for patients who have consented to be followed 
for safety assessments, including basic fasting lipids, after withdrawing from IMP treatment, all 
assessments except for those procedures pertaining to IMP management (IMP dispensing, IMP 
compliance, IMP accountability) should be completed. 
Note:  If this visit is being conducted by telephone contact for patients who have consented to be 
followed by phone for safety assessments after withdrawing from IMP treatment, collect 
information as reported by the patient regarding AEs, concomitant medication, and current health 
status. 
New Text: 
Patients will undergo the following assessments and procedures at Visit T3: 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints(starting from signing of the 
informed consent document) 
• Vital signs 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• PK sample prior to dose 
• Conduct diet and exercise counseling 
• Drug return and recording of drug complianceRecord unused study drug and reissue 
IMP and ezetimibe bottles 
• Schedule next visit 


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Note:  If this visit is being conducted at the site for patients who have consented to be followed 
for safety assessments, including basic fasting lipids, after withdrawing from IMP treatment, all 
assessments except for those procedures pertaining to IMP management (IMP dispensing, IMP 
compliance, IMP accountability) should be completed. 
Note:  If this visit is being conducted by telephone contact for patients who have consented to be 
followed by phone for safety assessments after withdrawing from IMP treatment, collect 
information as reported by the patient regarding AEs, concomitant medication, and current health 
status. 
 
CHANGE 24 STUDY PROCEDURES REVISIONS 
Location:  
Section 10.2.7, Treatment Week 12/EOS (Visit T4; Day 85 ±3 days) 
Original Text: 
Patients will undergo the following assessments and procedures at Visit T4: 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs (starting from signing of the informed consent document) 
• Physical Exam 
• Weight (kg) 
• 12-lead ECG 
• Vital Signs 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Special fasting lipids and other biomarkers (including apoB and hs-CRP)  
• HbA1C 
• Conduct diet and exercise counseling 
• Drug return and recording of drug compliance 
• Complete study status in IWRS (ie, early withdrawal or completed study). 
New Text: 
Patients will undergo the following assessments and procedures at Visit T4: 
• Concomitant and prohibited medication review (ongoing) 
• Assess AEs, SAEs, and potential clinical endpoints(starting from signing of the 
informed consent document) 
• Physical Exam 
• Weight (kg) 


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• 12-lead ECG 
• Vital Signs 
• Clinical safety laboratory evaluations (hematology, blood chemistry, and urinalysis) 
• Basic fasting lipids (TC, calculated LDL-C, HDL-C, non-HDL-C, and TG) 
• Special fasting lipids and other biomarkers (including apoB and hs-CRP)  
• HbA1C 
• PK sample prior to dose 
• Conduct diet and exercise counseling 
• Drug return and recording of drug compliance 
• Complete study status in IWRS (ie, early withdrawal or completed study). 
 
CHANGE 25 SUBJECT WITHDRAWAL CRITERIA REVISIONS 
Location:  
Section 10.3.1, Early Withdrawal from the Study 
Original Text: 
Patients must remain in the study until the last scheduled visit at Week 12 (Visit T4) to be 
considered as having completed participation in the study.  
Patients who withdraw from IMP prior to Week 12 (Visit T4) for any reason will be asked to 
continue to be followed for safety assessments, including basic fasting lipids, at clinic visit 
following the protocol-specified visit schedule (see Appendix 1).  The patient must provide 
consent to be followed in the study after withdrawing from IMP treatment.  Protocol procedures 
to be completed for patients who consent will include those specified at each visit as noted in 
Schedule of Events (see Appendix 1).  
Patients who temporarily withdraw from IMP prior to Week 12 (Visit T4) for any reason may 
restart IMP providing that (1) the patient and the investigator are in agreement regarding this 
course of action, (2) the patient has been off of IMP for 4 weeks or less; and (3) IMP can be 
started as soon as possible.  For cases where the patient has been off of IMP for more than 
4 weeks, the investigator must contact the medical monitor for approval prior to restarting IMP. 
Patients who do not provide consent to continue to return to the clinic for safety assessments will 
be asked to participate in phone calls from the site at protocol-specified visits (see Appendix 1), 
or at a minimum at 12 weeks, to collect information on AEs, concomitant medications, and 
current health status.  The patient must provide consent to be contacted by phone by site 
personnel for the purposes of assessing current AEs and current health status. 
New Text: 
Patients must remain in the study until the last scheduled visit at Week 12 (Visit T4) to be 
considered as having completed participation in the study.  


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Patients who withdraw from IMP and/or ezetimibe prior to Week 12 (Visit T4) for any reason 
will be asked to continue to be followed for safety assessments, including basic fasting lipids, at 
clinic visit following the protocol-specified visit schedule (see Appendix 1).  The patient must 
provide consent to be followed in the study after withdrawing from IMP treatment.  Protocol 
procedures to be completed for patients who consent will include those specified at each visit as 
noted in Schedule of Events (see Appendix 1).  
Patients who temporarily withdraw from IMP and/or ezetimibe prior to Week 12 (Visit T4) for 
any reason may restart IMP and/or ezetimibe providing that (1) the patient and the investigator 
are in agreement regarding this course of action, (2) the patient has been off of IMP for 4 weeks 
or less; and (3) IMP can be started as soon as possible.  For cases where the patient has been off 
of IMP for more than 4 weeks, the investigator must contact the medical monitor for approval 
prior to restarting IMP. 
Patients who do not provide consent to continue to return to the clinic for safety assessments will 
be asked to participate in phone calls from the site at protocol-specified visits (see Appendix 1), 
or at a minimum at 12 weeks, to collect information on AEs, concomitant medications, and 
current health status.  The patient must provide consent to be contacted by phone by site 
personnel for the purposes of assessing current AEs and current health status. 
 
CHANGE 26 ASSESSMENT OF SAFETY REVISIONS 
Location:  
Synopsis; Section 11.1.6.2:  Laboratory Parameters (Safety) 
Original Text: 
Table 3: 
Clinical Laboratory Parameters (Safety) (Continued) 
Clinical Laboratory Test 
Clinical Laboratory Test 
Urinalysis (Microscopic)-only if urine dipstick 
abnormal 
Coagulation (screening for all patients, T1 and 
3-5 days after T1 in patients receiving 
anticoagulation therapy, only) 
• Bacteria 
• Casts 
• Crystals 
• Epithelial cells 
• RBC 
• WBC 
• Prothrombin time (PT) 
• International normalized ratio (INR) 


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Clinical Laboratory Test 
Clinical Laboratory Test 
Other Screening Labs 
Additional samples 
• Hepatitis B surface antigen (HBsAg) 
• Hepatitis C virus (HCV)b 
• Serum pregnancy test (only for 
females of childbearing potential) 
• Follicle-stimulating hormone (FSH; 
Females <55 years and >1 year 
without menses) 
• Urine pregnancy test prior to 
randomization- (for female of child 
bearing potential) 
• Thyroid-stimulating hormone (TSH) 
• Hemoglobin A1C (HbA1C) 
• Reserve blood samples for potential 
future measurement of biomarkers 
• Pharmacogenomic (PG) sample 
(Reserve genetic blood sample; 
optional) 
a If TB ≥1.2 × ULN, a reflex indirect (unconjugated) bilirubin will be obtained. 
b If hepatitis C antibody (HCV-AB) is positive, a reflex HCV RNA will be performed to rule out active disease. 
11.1.6.2 
Other Assessments 
All patients will be invited to provide a blood sample for potential future genetic testing, but 
participation in this portion of the study is optional and only where approved by the IRB/IEC and 
by local law. 
11.1.6.3 
Sample Collection, Storage, and Shipping 
Clinical laboratory samples will be collected by appropriate clinical site personnel and then 
shipped according to a separate laboratory manual provided by the central laboratory.  Reserve 
samples will be stored frozen for potential future measurement of additional bempedoic acid 
safety and efficacy biomarkers.  A reserve genetic blood sample (optional) will also be stored 
frozen for potential future bempedoic acid genetic analyses.  
Blood draws for lipids, TG, and glucose must meet the fasting criterion listed below.  If this 
criterion has not been met, these blood samples will NOT be collected.  If this criterion can be 
met by rescheduling the clinic visit to occur within 3 days, the lipid, TG, and/or glucose blood 
samples will be collected at the rescheduled clinic visit only.  
• Blood samples will be drawn after a minimum 10-hour fast (water is allowed) 


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New Text: 
Table 3: 
Clinical Laboratory Parameters (Safety) (Continued) 
Clinical Laboratory Test 
Clinical Laboratory Test 
Urinalysis (Microscopic)-only if urine dipstick 
abnormal 
Coagulation (screening for all patients, T1 and 
3-5 days after T1 in patients receiving 
anticoagulation therapy, only) 
• 
Bacteria 
• 
Casts 
• 
Crystals 
• 
Epithelial cells 
• 
RBC 
• 
WBC 
• 
Prothrombin time (PT) 
• 
International normalized ratio (INR) 
Other Screening Labs 
Additional samples 
• 
Hepatitis B surface antigen (HBsAg) 
• 
Hepatitis C virus (HCV)b 
• 
Serum pregnancy test (only for females 
of childbearing potential) 
• 
Follicle-stimulating hormone (FSH; 
Females <55 years and >1 year without 
menses) 
• 
Urine pregnancy test prior to 
randomization- (for female of child 
bearing potential) 
• 
Thyroid-stimulating hormone (TSH) 
• 
Hemoglobin A1C (HbA1C) 
• 
Reserve blood samples for potential 
future measurement of biomarkers 
• 
Pharmacogenomic (PG) sample 
(Reserve genetic blood sample; 
optional) 
a If TB ≥1.2 × ULN, a reflex indirect (unconjugated) bilirubin will be obtained. 
b If hepatitis C antibody (HCV-AB) is positive, a reflex HCV RNA will be performed to rule out active 
disease. 
11.1.6.2 
Other Assessments 
All patients will be invited to provide a blood sample for potential future genetic testing, but 
participation in this portion of the study is optional and only where approved by the IRB/IEC and 
by local law. 
11.1.6.211.1.6.3 Sample Collection, Storage, and Shipping 
Clinical laboratory samples will be collected by appropriate clinical site personnel and then 
shipped according to a separate laboratory manual provided by the central laboratory.  Reserve 
samples will be stored frozen for potential future measurement of additional bempedoic acid 
safety and efficacy biomarkers.  A reserve genetic blood sample (optional) will also be stored 
frozen for potential future bempedoic acid genetic analyses.  


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Blood draws for lipids, TG, and glucose must meet the fasting criterion listed below.  If this 
criterion has not been met, these blood samples will NOT be collected.  If this criterion can be 
met by rescheduling the clinic visit to occur within 3 days, the lipid, TG, and/or glucose blood 
samples will be collected at the rescheduled clinic visit only.  
• Blood samples will be drawn after a minimum 10-hour fast (water is allowed) 
 
CHANGE 27 ASSESSMENT OF SAFETY REVISIONS 
Location: 
Section 11.1.6.3.1, Monitoring and Management of Elevated Liver Function Test 
Original Text: 
• If repeat LFT assessment confirms ALT and/or AST >5 × ULN, patient should be 
withdrawn from IMP treatment, but will be asked to continue to be followed for 
safety using the protocol-specified visit schedule (see Appendix 1). 
• If repeat LFT assessment confirms ALT and/or AST >3 × ULN in addition to any of 
the following, the patient should be given no further IMP treatment, but will be asked 
to continue to be followed for safety using the protocol-specified visit schedule (see 
Appendix 1): 
− TB >2 × ULN 
Note:  In the case of patients with Gilbert’s disease, TB will be fractionated and 
the determination of 2 × ULN will be based upon direct (conjugated) bilirubin. 
− INR >1.5 × ULN (unless the patient is on stable dose of anticoagulation 
medication) 
− Appearance or worsening of right upper abdominal discomfort, anorexia, fatigue, 
nausea, vomiting, fever, rash, or eosinophilia 
New Text: 
• If repeat LFT assessment confirms ALT and/or AST >5 × ULN, patient should be 
withdrawn from IMP treatment, but will be asked to continue to be followed for 
safety using the protocol-specified visit schedule (see Appendix 1) or more 
frequently as determined by the investigator. 
• If repeat LFT assessment confirms ALT and/or AST >3 × ULN in addition to any of 
the following, the patient should be given no further IMP treatment, but will be asked 
to continue to be followed for safety using the protocol-specified visit schedule (see 
Appendix 1) or more frequently as determined by the investigator: 
− TB >2 × ULN 
Note:  In the case of patients with Gilbert’s disease, TB will be fractionated and 
the determination of 2 × ULN will be based upon direct (conjugated) bilirubin. 
− INR >1.5 × ULN (unless the patient is on stable dose of anticoagulation 
medication) 


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− Appearance or worsening of right upper abdominal discomfort, anorexia, fatigue, 
nausea, vomiting, fever, rash, or eosinophilia 
 
CHANGE 28 ASSESSMENT OF safety revisions 
Location:  
Section 11.1.6.3.4, Monitoring and Management of Elevated Creatine Kinase 
Original Text: 
If at any time after randomization a patient experiences a marked CK elevation >5 × ULN, the 
patient will undergo repeat confirmatory assessment as soon as is reasonably possible, preferably 
within 3 to 7 days of the laboratory result becoming available.  
Repeat CK assessment will include query for related symptoms.  
• If the repeat CK assessment confirms an unexplained (ie, not associated with recent 
trauma or physically strenuous activity) CK abnormality >5 × ULN, if asymptomatic 
the investigator with input from the Sponsor may consider continuing study 
medication with continued CK assessments every 1-2 weeks.  
• If symptomatic, the following steps should be completed: 
− Hold IMP 
− Clarification of the nature, duration, and intensity of muscle symptoms 
New Text: 
If at any time after randomization a patient experiences a marked CK elevation >5 × ULN, the 
patient will undergo repeat confirmatory assessment as soon as is reasonably possible, preferably 
within 3 to 7 days of the laboratory result becoming available.  
Repeat CK assessment will include query for related symptoms.  
• If the repeat CK assessment confirms an unexplained (ie, not associated with recent 
trauma or physically strenuous activity) CK abnormality >5 × ULN, if asymptomatic 
the investigator with input from patient should receive further assessment and 
investigation into the Sponsor may consider continuing cause, assess whether there 
is renal injury, and measure CK approximately weekly or more frequently if 
clinically indicated until resolution.  If CK levels continue to rise, IMP and study-
supplied ezetimibe should be discontinuedstudy medication with continued CK 
assessments every 1-2 weeks.  
• If symptomatic, the following steps should be completed: 
− Hold IMP and study-supplied ezetimibe 
− Clarification of the nature, duration, and intensity of muscle symptoms 
 


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CHANGE 29 ASSESSMENT OF SAFETY 
Location:  
Section 11.1.6.6, Collection and Assessment of Pharmacokinetic Samples 
Original Text: 
Pharmacokinetic samples will be collected from patients prior to the first dose at Week 0 
(Visit T1), Week 4 (Visit T2), Week 8 (Visit T3), and Week 12 (Visit T4), dosing time and PK 
sampling time must be documented, for use in further developing the population PK model.  
Plasma concentrations of ETC-1002 and its metabolite (ESP15228) will be determined using 
validated methods.  Plasma PK samples will be labeled with preprinted information, including 
study number, patient identification number, study day, nominal time of sample collection, 
matrix, and a text identification (ie, “Plasma PK”).  See the study laboratory manual for further 
instructions. 
New Text: 
Pharmacokinetic samples will be collected from patients prior to the first dose at Week 0 
(Visit T1), Week 4 (Visit T2), Week 8 (Visit T3), and Week 12 (Visit T4), dosing time and PK 
sampling time must be documented, for use in further developing the population PK model.  
Plasma concentrations of ETC-1002 and its metabolite (ESP15228) will be determined using 
validated methods.  Plasma PK samples will be labeled with preprinted information, including 
study number, patient identification number, study day, nominal time of sample collection, 
matrix, and a text identification (ie, “Plasma PK”).  See the study laboratory manual for further 
instructions. 
 
CHANGE 30 ASSESSMENT OF SAFETY -- EXPLORATORY BIOMARKER 
MEASUREMENT REVISIONS 
Location:  
Section 11.1.6.7, Exploratory Biomarker Measurement 
Original Text: 
11.1.6.7 
Exploratory Biomarker Measurement 
Additional exploratory safety, efficacy, PK, or potential biomarkers may be assayed from 10 mL 
blood samples reserved for potential future measurement of potential biomarkers. 
New Text: 
11.1.6.7 
Exploratory Biomarker Measurement 
Additional exploratory safety, efficacy, PK, or potential biomarkers may be assayed from 10 mL 
blood samples reserved for potential future measurement of potential biomarkers. 
 


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CHANGE 31 ASSESSMENT OF SAFETY – GENETIC TESTING REVISIONS 
Location:  
Section 11.1.6.9, Genetic Testing 
Original Text: 
11.1.6.9 
Genetic Testing 
As part of this study, all patients will be invited to provide a blood sample to be banked for 
potential future genetic analyses, but participation in this portion of the study is optional and 
where is approved by the IRB/IEC and by local law.  Those who choose not to provide a sample 
for genetic analysis may still participate in the main portion of the study.  Samples will be 
anonymized before testing to assure that the results cannot be traced back to an individual 
patient.  Signing a separate informed consent document is required to obtain this sample. 
New Text: 
11.1.6.9 
Genetic Testing 
As part of this study, all patients will be invited to provide a blood sample to be banked for 
potential future genetic analyses, but participation in this portion of the study is optional and 
where is approved by the IRB/IEC and by local law.  Those who choose not to provide a sample 
for genetic analysis may still participate in the main portion of the study.  Samples will be 
anonymized before testing to assure that the results cannot be traced back to an individual 
patient.  Signing a separate informed consent document is required to obtain this sample. 
 
CHANGE 32 ASSESSMENT OF SAFETY – ADVERSE EVENTS REVISIONS 
Location:  
Section 11.2.3, Reporting 
Original Text: 
All AEs occurring during the course of the study (starting from signing informed consent to 
study completion) will be collected on the AE eCRF.  Patients should be instructed to report any 
AE that they experience to the investigator.  Beginning with Visit S2 (Week -4), investigators 
should make an assessment for AEs at each visit and record the event on the appropriate AE 
eCRF.  
New Text: 
All AEs occurring during the course of the study (starting from signing informed consent to 
study completion or discontinuation) will be collected on the AE eCRF.  Patients should be 
instructed to report any AE that they experience through 30 days following the last dose of 
IMP to the investigator.  Any SAE that occurs within 30 days following the last study visit 
should be reported to the Sponsor per Section 11.3.  Beginning with Visit S2 (Week -4), 
investigators should make an assessment for AEs at each visit and record the event on the 
appropriate AE eCRF.  
 


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CHANGE 33 ASSESSMENT OF SAFETY – ADVERSE EVENTS REVISIONS 
Location:  
Section 11.2.5, Relationship 
Original Text: 
It is the investigator’s responsibility to assess the relationship between the study drug and the 
AE.  The degree of “relatedness” of the AE to the study drug may be described using the 
following scale: 
New Text: 
It is the investigator’s responsibility to assess the relationship of the AE with between both the 
study drugIMP and ezetimibeand the AE.  The degree of “relatedness” of the AE to the study 
drug IMP and ezetimibe should may be described using the following scale: 
 
CHANGE 34 ASSESSMENT OF SAFETY –ADVERSE EVENTS REVISIONS 
Location:  
Section 11.2.7.1, Definition of Serious Adverse Event 
Original Text: 
Any clinical endpoints that meet SAE criteria will be also reported as SAEs.  The CEC will 
adjudicate clinical endpoints in a blinded fashion, but the DMC will review clinical endpoints 
and SAEs in an unblinded fashion. 
11.3. Reporting Serious Adverse Events 
All SAEs, regardless of relationship to study drug, occurring from the time of informed consent 
until 30 days following study completion (for most patients 30 days following their Week 12 
visit) or study discontinuation, must be reported by the principal investigator or designee to the 
authorized safety designee within 24 hours of the principal investigator or the clinical site 
becoming aware of the occurrence.  All SAEs that the investigator considers related to study 
drug that occur after the 30-day follow-up of the study period must be reported to the Sponsor.  
New Text: 
Any clinical endpoints that meet SAE criteria will be also reported as SAEs.  The CEC will 
adjudicate clinical endpoints in a blinded fashion, but the DMC will review clinical endpoints 
and SAEs in an unblinded fashion. 
11.2.7.2 
Definition of Serious Adverse Event Events or Outcomes not Qualifying as Serious 
Adverse Events 
The following are not considered SAEs and therefore do not need to be reported as such: 
• Preplanned or elective hospitalization including social and/or convenience 
situations (eg, due to inclement weather) 


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• Overdose of either Esperion study drug or concomitant medication unless the event 
meets SAE criteria (eg, hospitalization).  However, the event should still be 
captured as a nonserious AE on the appropriate eCRF page 
11.2.7.3 
Clinical Laboratory Assessments as Adverse Events and Serious Adverse Events 
It is the responsibility of the investigator to assess the clinical significance of all abnormal 
values as defined by the list of reference ranges from the local laboratory.  In some cases, 
significant changes in lab values within the normal range will require similar judgment. 
11.3. Reporting Serious Adverse Events 
All SAEs, regardless of relationship to study drug, occurring from the time of informed consent 
until 30 days following study completion last dose of IMP (for most patients 30 days following 
their Week 12 visit) or study discontinuation, must be reported by the principal investigator or 
designee to the authorized safety designee within 24 hours of the principal investigator or the 
clinical site becoming aware of the occurrence.  All SAEs that the investigator considers related 
to study drug that occur after the 30-day follow-up of the study period must be reported to the 
Sponsor. 
 
CHANGE 35 STATISTICS REVISIONS 
Location:  
Section 12.5, Primary Efficacy Analysis 
Original Text: 
The primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C.  
Baseline is defined as the mean of the values from Week -1 (Visit S3) and predose 
Day 1/Week 0 (Visit T1).  The primary efficacy endpoint will be analyzed using analysis of 
covariance (ANCOVA), with treatment group as a factor and baseline LDL-C as a covariate.  
The ANCOVA will be performed using the FAS, with patients included in their randomized 
treatment group regardless of the treatment they actually received.   
Two methods for data handling will be used:  the first is observed case data only, while the 
second will involve specification of the missing data mechanism using a pattern mixture model 
(PMM).  The primary analysis will be that from the PMM, while the observed case analysis will 
be used as confirmatory.  The PMM will be used to specify different imputation strategies 
depending on whether the patient is still on study treatment.  Imputed datasets will be analyzed 
using ANCOVA with treatment as a factor and baseline LDL-C as a covariate.  Approximately 
100 imputed datasets will be created, with results from the analysis of each imputed dataset 
combined using Rubin’s method.  For each ANCOVA (observed case; imputation via PMM), the 
least squares mean (LSM) and standard error (SE) will be provided for both treatment groups, 
along with the placebo-corrected LSM, its 95% confidence interval (CI), and associated p-value. 
New Text: 
The primary efficacy endpoint is the percent change from baseline to Week 12 in LDL-C.   
Baseline LDC-C is defined as the mean of the values from Week -1 (Visit S3) and predose 
Day 1/Week 0 (Visit T1).  The primary efficacy endpoint will be analyzed using analysis of 


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covariance (ANCOVA), with treatment group as a factor and baseline LDL-C as a covariate.  
The ANCOVA will be performed using the FAS, with patients included in their randomized 
treatment group regardless of the treatment they actually received.  The details of the ANCOVA 
model and options to correct for unequal variances and group size will be described in the 
SAP. 
Two methods for data handling will be used:  the first is observed case data only, while the 
second will involve specification of the missing data mechanism using a pattern mixture model 
(PMM).  The primary analysis will be that from the PMM, while the observed case analysis will 
be used as confirmatory.  The PMM will be used Missing data for the primary endpoint will be 
imputed using a multiple imputation method that accounts for treatment adherence.  A pattern 
mixture model (PMM) will be used to specify different imputation strategies depending on 
whether the patient is still on study treatment.  Imputed datasets will be analyzed using 
ANCOVA with treatment as a factor and baseline LDL-C as a covariate.  Approximately 100200 
imputed datasets will be created, with results from the analysis of each imputed dataset 
combined using Rubin’s method.  For each ANCOVA (observed case; imputation via PMM), 
The least squares mean (LSM) and standard error (SE) will be provided for both treatment 
groups, along with the placebo-corrected LSM, its 95% confidence interval (CI), and associated 
p-value.  A confirmatory analysis using observed data only will also be performed for the 
primary endpoint. 
 
CHANGE 36 STATISTICS REVISIONS 
Location:  
Synopsis; Section 12.6, Secondary and Tertiary Efficacy Endpoints 
Original Text: 
For the remaining secondary efficacy endpoints (percent change from baseline to Week 12 in TG 
and HDL-C) and the tertiary efficacy endpoints, a significance level of 0.05 will be used; given 
the large number of remaining endpoints (Section 5.4.3), the p-values for those endpoints will be 
considered descriptive. 
Change from baseline to Week 12 in LDL-C and percent change from baseline to Week 12 in 
HDL-C, non-HDL-C, TG, TC, apoB, and hs-CRP will each be analyzed using ANCOVA with 
treatment group as a factor and the relevant baseline as the covariate.  Baseline for non-HDL-C, 
HDL-C, TC, and TG is defined as the mean of the values from Week -1 (Visit S3) and predose 
Day 1/Week 0 (Visit T1).  Baseline for apoB and hs-CRP is defined as the predose 
Day 1/Week 0 (Visit T1) value.  Each ANCOVA will be performed using the FAS, with patients 
included in their randomized treatment group regardless of the treatment they actually received.  
Only observed case data will be included (no imputation will be performed for missing data).  
For each lipid parameter at each time point, the LSM and SE will be provided for both treatment 
groups, along with the placebo-corrected LSM, its 95% CI and associated p-value.  
For all continuous efficacy endpoints (percent change from baseline in LDL-C, HDL-C, 
non-HDL-C, TC, TG, apoB, and hs-CRP, change from baseline in LDL-C; percent change and 
change from baseline in lipid levels to Weeks 4, 8, and 12, as appropriate), the ANCOVA 
assumption of normality will be assessed.  If non-normality of the data is found at any time point 


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for any parameter, either the data will be transformed so that it is normally distributed or a 
nonparametric test will be used instead of the planned ANCOVA. 
New Text: 
For the remaining secondary efficacy endpoints (percent change from baseline to Week 12 in TG 
and HDL-C) and the tertiary efficacy endpoints, a significance level of 0.05 will be used; given 
the large number of remaining endpoints (Section 5.4.3), the p-values for those endpoints will be 
considered descriptive. 
Change from baseline to Week 12 in LDL-C and In general, change or percent change from 
baseline to Week 12 in HDL-C, non-HDL-C, TG, TC, apoB, and hs-CRP in lipid parameters at 
a given time point will each be analyzed using a similar ANCOVA model for the primary 
endpoint with treatment group as a factor and the relevant baseline as the covariate.  Baseline for 
non-HDL-C, HDL-C, TC, and TG is defined as the mean of the values from Week -1 (Visit S3) 
and predose Day 1/Week 0 (Visit T1).  Baseline for apoB and hs-CRP is defined as the predose 
Day 1/Week 0 (Visit T1) value.   
Each ANCOVA will be performed using the FAS, with patients included in their randomized 
treatment group regardless of the treatment they actually received.  Only observed case data will 
be included (no imputation will be performed for missing data  Same imputation method 
described for the primary endpoint will be used for the key secondary endpoints, while only 
observed data analysis will be used for other secondary and tertiary endpoints.  For each lipid 
parameter at each time point, the LSM and SE will be provided for both treatment groups, along 
with the placebo-corrected LSM, its 95% CI and associated p-value. 
For all continuous efficacy endpoints (percent change from baseline in LDL-C, HDL-C, 
non-HDL-C, TC, TG, apoB, and hs-CRP, change from baseline in LDL-C; percent change and 
change from baseline in lipid levels to Weeks 4, 8, and 12, as appropriate), the The ANCOVA 
assumption of normality will be assessed.  If non-normality of the data is found at any time point 
for any parameter, either the data will be transformed so that it is normally distributed or a 
nonparametric test will be used considered instead of the planned ANCOVA. 
 
CHANGE 37 APPENDIX 1 SCHEDULE OF EVENTS (PATIENT VISIT SCHEDULE) 
REVISIONS 
Location:  
Appendix 1, Schedule of Events (Patient Visit Schedule) 
Original Text: 
Visit 
S11 
S2 
S3 
T1 
T2 
T3 
T4 
Week 
-5 
-4 
-1 
0 
4 
8 
12/EOS 
Procedure 
Day 
-42 to -35 
Day 
-28 ± 3 
Day 
-7 ± 3 
Day 1 
Day 
29 ± 3 
Day 
57 ± 3 
Day 
85 ± 3 
Informed Consent 
X 
 
 
 
 
 
 
Enrollment Criteria 
X 
X 
X 
X 
 
 
 


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Visit 
S11 
S2 
S3 
T1 
T2 
T3 
T4 
Week 
-5 
-4 
-1 
0 
4 
8 
12/EOS 
Procedure 
Day 
-42 to -35 
Day 
-28 ± 3 
Day 
-7 ± 3 
Day 1 
Day 
29 ± 3 
Day 
57 ± 3 
Day 
85 ± 3 
Demographics 
X 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
Concomitant\Prohibited 
Medications 
X 
X 
X 
X 
X 
X 
X 
Adverse Event Recording 
 
X 
X 
X 
X 
X 
X 
Physical Exam 
 
X 
 
 
 
 
X 
Weight3 
X 
 
 
X3 
 
 
X 
Height/BMI 
X 
 
 
 
 
 
 
12-Lead ECG4 
 
X 
 
 
 
 
X 
Vital Signs5 
X 
X 
X 
X 
X 
X 
X 
Serology6 
 
X 
 
 
 
 
 
Serum Pregnancy/FSH 7 
X 
 
 
 
 
 
 
Urine Pregnancy  
 
 
 
X 
 
 
 
TSH 
X 
 
 
 
 
 
 
Clinical Safety Labs8 
X 
 
 
X 
X 
X 
X 
Basic Fasting Lipids9 
X 
 
X 
X 
X 
X 
X 
Special Fasting Lipids and 
Other Biomarkers10 
 
 
 
X 
 
 
X 
HbA1C 
X 
 
 
X 
 
 
X 
PK sample 
 
 
 
X predose 
X 
X 
X 
Diet and exercise counseling 
X 
X 
X 
X 
X 
X 
X 
Randomization 
 
 
 
X 
 
 
 
Single Blind/Ezetimibe Drug 
Dispensing 
 
X 
 
X11 
 
 
 
Double Blind Drug Dispensing 
 
 
 
X 
 
 
 
Drug Return 
 
 
X 
X 
X 
X 
X 
 
BMI = body mass index; ECG = electrocardiogram; FSH = follicle-stimulating hormone, HbA1C = hepatitis B surface 
antigen; PK = pharmacokinetics; TSH = thyroid-stimulating hormone. 
1 An optional visit approximately 1 week later MAY be completed if patient fails to meet a lipid entry criterion.  If 
this optional visit is completed, the mean of the LDL values, or repeat TG value, will be used to determine 
eligibility. 
2 All procedures will be completed at end of study or early termination. 
3 Body weight will be measured in the morning while fasting, using consistent scales, after voiding, and without 
shoes and outerwear (eg, coats). 
4 Single 12-lead ECG will be collected prior to any blood sample collection. 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 142 of 144 
5 Vital signs will include SBP, DBP, and HR, and will be collected prior to any blood sample collection.  Patient will 
rest for 5 minutes prior to assessments. 
6 Serology for Hep B antigen, Hep C antibody. 
7 FSH completed in appropriate postmenopausal women only; pregnancy test completed in non-postmenopausal 
women only. 
8 Clinical safety labs include hematology, blood chemistry, and urinalysis.  Coagulation panel at S1 only, unless 
receiving anticoagulants (then test at T1 and repeat 3-5 days after starting IMP). 
9 Basic fasting lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides. 
10 Includes apoB and hs-CRP. 
11 Ezetimibe dispensing only. 
 
New Text: 
Visit 
S11 
S2 
S3 
T1 
T2 
T3 
T42 
Week 
-5 
-4 
-1 
0 
4 
8 
12/EOS 
Procedure 
Day 
-42 to -35 
±7 days 
Day 
-28 ± 3 
Day 
-7 ± 3 
Day 1 
Day 
29 ± 3 
Day 
57 ± 3 
Day 
85 ± 3 
Informed Consent 
X 
 
 
 
 
 
 
Enrollment Criteria 
X 
X 
X 
X 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
Concomitant\Prohibited 
Medications 
X 
X 
X 
X 
X 
X 
X 
Adverse Event Recording 
 
X 
X 
X 
X 
X 
X 
Physical Exam 
 
X 
 
 
 
 
X 
Weight3 
X 
 
 
X3 
 
 
X 
Height/BMI 
X 
 
 
 
 
 
 
12-Lead ECG4 
 
X 
 
 
 
 
X 
Vital Signs5 
X 
X 
X 
X 
X 
X 
X 
Serology6 
 
X 
 
 
 
 
 
Serum Pregnancy/FSH 7 
X 
 
 
 
 
 
 
Urine Pregnancy 7 
 
 
 
X 
 
 
 
TSH 
X 
 
 
 
 
 
 
Clinical Safety Labs8 
X 
 
X 
X 
X 
X 
X 
Basic Fasting Lipids9 
X 
 
X 
X 
X 
X 
X 
Special Fasting Lipids and 
Other Biomarkers10 
 
 
 
X 
 
 
X 
HbA1C 
X 
 
 
X 
 
 
X 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 143 of 144 
Visit 
S11 
S2 
S3 
T1 
T2 
T3 
T42 
Week 
-5 
-4 
-1 
0 
4 
8 
12/EOS 
Procedure 
Day 
-42 to -35 
±7 days 
Day 
-28 ± 3 
Day 
-7 ± 3 
Day 1 
Day 
29 ± 3 
Day 
57 ± 3 
Day 
85 ± 3 
PK sample (prior to IMP 
dosing) 
 
 
 
X predose 
X 
X 
X 
Diet and exercise counseling 
X 
X 
X 
X 
X 
X 
X 
Randomization 
 
 
 
X 
 
 
 
Single Blind/Ezetimibe Drug 
Dispensing 
 
X 
 
X11 
 
 
 
Double Blind Drug Dispensing 
 
 
 
X 
 
 
 
Drug Return12 
 
 
X 
X 
X 
X 
X 
 
BMI = body mass index; ECG = electrocardiogram; FSH = follicle-stimulating hormone, HbA1C = hepatitis B surface 
antigen; PK = pharmacokinetics; TSH = thyroid-stimulating hormone. 
1 An optional visit approximately 1 week later MAY be completed if patient fails to meet TGa lipid entry criterion.  If 
this optional visit is completed, the mean of the LDL values, or repeat TG value, will be used to determine 
eligibility. 
2 All procedures will be completed at end of study or early termination. 
3 Body weight will be measured in the morning while fasting, using consistent scales, after voiding, and without 
shoes and outerwear (eg, coats). 
4 Single 12-lead ECG will be collected prior to any blood sample collection. 
5 Vital signs will include SBP, DBP, and HR, and will be collected prior to any blood sample collection.  Patient will 
rest for 5 minutes prior to assessments. 
6 Serology for Hep B antigen, Hep C antibody. 
7 FSH completed in appropriate postmenopausal women only; pregnancy test completed in non-postmenopausal 
women only. 
8 Clinical safety labs include hematology, blood chemistry, and urinalysis.  Coagulation panel at S1 only, unless 
receiving anticoagulants (then test at T1 and repeat 3-5 days after starting IMP). For patients not taking ezetimibe 
at S1, measure blood chemistry and CK only at S3. 
9 Basic fasting lipids include total cholesterol, calculated LDL-C, HDL-C, non-HDL-C, and triglycerides. 
10 Includes apoB and hs-CRP. 
11 Ezetimibe dispensing only. 
12 Record unused IMP and ezetimibe and reissue study drug bottles at visits T1 (ezetimibe only), T2, and T3.  
Perform final drug count at visit T4. 
 
CHANGE 38 APPENDIX 2 SPONSOR’S SIGNATURE REVISIONS 
Location: 
Appendix 2, Sponsor’s Signature (all pages within Appendix 2) 


Bempedoic acid 
 
Esperion Therapeutics, Inc. 
Clinical Study Protocol 1002-048 
 
Amendment 2, 10 February 2017  
Confidential 
Page 144 of 144 
Original Text: 
SPONSOR’S SIGNATURE 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 
Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid 
(ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with 
Elevated LDL-C  
Study Number: 
1002-048 
New Text: 
SPONSOR’S SIGNATURE 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 
Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid 
(ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with 
Elevated LDL-C on Low Dose or Less than Low Dose Statins 
Study Number: 
1002-048 
 
CHANGE 39 APPENDIX 3 INVESTIGATOR’S SIGNATURE REVISIONS 
Location: 
Appendix 3, Investigator’s Signature 
Original Text: 
INVESTIGATOR’S SIGNATURE 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 
Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid 
(ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with 
Elevated LDL-C  
Study Number: 
1002-048 
New Text: 
INVESTIGATOR’S SIGNATURE 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 
Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid 
(ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with 
Elevated LDL-C on Low Dose or Less than Low Dose Statins 
Study Number: 
1002-048 
 

SAP_001.pdf: 
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for purposes of  posting on clinicaltrials.gov


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1.
INTRODUCTION.............................................................................................................................11
2.
STUDY OBJECTIVES......................................................................................................................11
3.
STUDY DESIGN...............................................................................................................................12
4.
PLANNED ANALYSIS.....................................................................................................................13
5.
ANALYSIS SETS ..............................................................................................................................14


6.
STATISTICAL CONSIDERATIONS .............................................................................................17
7.
OUTPUT PRESENTATIONS.........................................................................................................19
8.
DISPOSITION AND WITHDRAWALS .......................................................................................19
9.
PROTOCOL DEVIATIONS ............................................................................................................19
10.
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS......................................19
11.
MEDICAL AND SURGICAL HISTORY.....................................................................................20
12.
CONCOMITANT ILLNESSES.....................................................................................................21
13.
MEDICATIONS ............................................................................................................................21


14.
STUDY MEDICATION COMPLIANCE AND EXPOSURE ....................................................22
15.
EFFICACY OUTCOMES..............................................................................................................23
16.
SAFETY OUTCOMES..................................................................................................................27


17.
DATA NOT SUMMARIZED OR PRESENTED .......................................................................33
18.
REFERENCES ...............................................................................................................................34
APPENDIX 1.PROGRAMMING CONVENTIONS FOR OUTPUT .................................................35
APPENDIX 2.PARTIAL DATE CONVENTIONS ..............................................................................42
APPENDIX 3.DMC TABLES, LISTINGS AND FIGURES ................................................................44
APPENDIX 4.DETAILS OF MULTIPLE IMPUTATION METHOD..............................................47


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APPENDIX5.LISTOFADVERSEEVENTSOFSPECIALINTEREST..........................................49
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ͻdŚĞŚĞĂĚĞƌƐŚŽƵůĚďĞƉůĂĐĞĚĂƚƚŚĞƚŽƉŽĨƚŚĞƉĂŐĞ;ƐĂŵĞƉůĂĐĞŽŶĞĂĐŚƉĂŐĞͿƌĞŐĂƌĚůĞƐƐŽĨƚŚĞƐŝǌĞŽƌ
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ͻZŽǁϲƐŚŽƵůĚďĞĂďůĂŶŬůŝŶĞ
ͻDŝǆĞĚĐĂƐĞƐŚŽƵůĚďĞƵƐĞĚĨŽƌƚŝƚůĞƐ
ͻdŚĞŽƵƚƉƵƚƚŝƚůĞƐƐŚŽƵůĚďĞĚĞƐŝŐŶĞĚƐŽƚŚĂƚƚŚĞǇĂƌĞĂƌƌĂŶŐĞĚĐŽŶƐŝƐƚĞŶƚůǇƚŚƌŽƵŐŚĂůůŽƵƚƉƵƚƐ͘&Žƌ
ĞǆĂŵƉůĞ͕ĐŽŶƚĞŶƚ;ĞŐsŝƚĂů^ŝŐŶƐͿĨŽůůŽǁĞĚďǇŵĞƚƌŝĐ;ĞŐŚĂŶŐĞĨƌŽŵĂƐĞůŝŶĞͿĞ͘Ő͘sŝƚĂů^ŝŐŶƐʹ
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ͻdŚĞĨŝƌƐƚůĞƚƚĞƌŽĨĂƚĞǆƚĞŶƚƌǇƐŚŽƵůĚďĞĐĂƉŝƚĂůŝǌĞĚ
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ͻǆƉŽŶĞŶƚŝĂƚŝŽŶǁŝůůďĞĞǆƉƌĞƐƐĞĚƵƐŝŶŐĂĚŽƵďůĞĂƐƚĞƌŝƐŬ͕ŝ͘Ğ͕͘ŵŵϯǁŝůůďĞǁƌŝƚƚĞŶĂƐŵŵΎΎϯ͘
ͻůůǀĂƌŝĂďůĞƐƚŚĂƚĂƌĞŽƵƚƉƵƚŝŶƚŚĞZ&;ǁŚŝĐŚŚĂǀĞĚĂƚĂƉƌĞƐĞŶƚͿƐŚŽƵůĚĂƉƉĞĂƌŝŶƚŚĞůŝƐƚŝŶŐƐ͕ĂůŽŶŐ
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ͻWĞƌĐĞŶƚǀĂůƵĞƐƐŚŽƵůĚďĞƌĞƉŽƌƚĞĚŝŶƐŝĚĞƉĂƌĞŶƚŚĞƐĞƐ͕ǁŝƚŚŽŶĞƐƉĂĐĞďĞƚǁĞĞŶƚŚĞĐŽƵŶƚĂŶĚƚŚĞůĞĨƚ
ƉĂƌĞŶƚŚĞƐŝƐŽĨƚŚĞƉĞƌĐĞŶƚĂŐĞ͘WĂƌĞŶƚŚĞƐĞƐƐŚŽƵůĚďĞũƵƐƚŝĨŝĞĚƚŽĂĐĐĞƉƚĂŵĂǆŝŵƵŵŽĨϭϬϬ͘ϬĂƐĂ
ǀĂůƵĞĂŶĚƉĂĚĚĞĚǁŝƚŚďůĂŶŬƐƉĂĐĞŝĨƚŚĞƉĞƌĐĞŶƚŝƐůĞƐƐƚŚĂŶϭϬϬ͘Ϭ͘ŶĞǆĂŵƉůĞŝƐŐŝǀĞŶďĞůŽǁ͗
ϳϳ;ϭϬϬ͘ϬйͿ
ϱϬ;ϲϰ͘ϵйͿ
Ϭ;Ϭ͘ϬйͿ
ͻWĞƌĐĞŶƚĂŐĞƐǁŝůůďĞƌĞƉŽƌƚĞĚƚŽŽŶĞĚĞĐŝŵĂůƉůĂĐĞ͕ĞǆĐĞƉƚƉĞƌĐĞŶƚƐфϭϬϬ͘ϬйďƵƚхϵϵ͘ϵйǁŝůůďĞ
ƉƌĞƐĞŶƚĞĚĂƐ͚хϵϵ͘ϵй͛;Ğ͘Ő͕͘ϵϵ͘ϵϵйŝƐƉƌĞƐĞŶƚĞĚĂƐхϵϵ͘ϵйͿ͖ĂŶĚƉĞƌĐĞŶƚƐфϬ͘ϭйǁŝůůďĞƉƌĞƐĞŶƚĞĚĂƐ
͚фϬ͘ϭй͛;Ğ͘Ő͕͘Ϭ͘ϬϴйŝƐƉƌĞƐĞŶƚĞĚĂƐфϬ͘ϭйͿ͘ZŽƵŶĚŝŶŐǁŝůůďĞĂƉƉůŝĞĚĂĨƚĞƌƚŚĞфϬ͘ϭйĂŶĚхϵϵ͘ϵйƌƵůĞ͘
Ő;фϬ͘ϭйͿ
;ϲ͘ϴйͿ
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WĞƌĐĞŶƚĂŐĞƐŵĂǇďĞƌĞƉŽƌƚĞĚƚŽϬĚĞĐŝŵĂůƉůĂĐĞƐĂƐĂƉƉƌŽƉƌŝĂƚĞ;ĨŽƌĞǆĂŵƉůĞ͕ǁŚĞƌĞƚŚĞ
ĚĞŶŽŵŝŶĂƚŽƌŝƐƌĞůĂƚŝǀĞůǇƐŵĂůůͿ͘
ͻtŚĞƌĞĐŽƵŶƚƐĂƌĞǌĞƌŽ͕ƉĞƌĐĞŶƚĂŐĞƐŽĨϬ͘ϬйƐŚŽƵůĚĂƉƉĞĂƌŝŶƚŚĞŽƵƚƉƵƚ͘
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ŽŶĨŝĚĞŶĐĞ/ŶƚĞƌǀĂůƐ͗
ͻƐĂƌƵůĞĐŽŶĨŝĚĞŶĐĞŝŶƚĞƌǀĂůƐĂƌĞŽƵƚƉƵƚƚŽŽŶĞƉůĂĐĞŵŽƌĞƚŚĂŶƚŚĞƌĂǁĚĂƚĂ͕ĂŶĚƐƚĂŶĚĂƌĚĚĞǀŝĂƚŝŽŶƐ
ĂŶĚƐƚĂŶĚĂƌĚĞƌƌŽƌƐƚŽƚǁŽƉůĂĐĞƐŵŽƌĞƚŚĂŶƚŚĞƌĂǁĚĂƚĂ
ͻŽŶĨŝĚĞŶĐĞŝŶƚĞƌǀĂůƐƐŚŽƵůĚďĞũƵƐƚŝĨŝĞĚƐŽƚŚĂƚƉĂƌĞŶƚŚĞƐĞƐĚŝƐƉůĂǇĞĚŽŶĐŽŶƐĞĐƵƚŝǀĞůŝŶĞƐŽĨĂƚĂďůĞ
͞ůŝŶĞƵƉ͘͟
ͻŽƵŶĚĂƌǇǀĂůƵĞƐŽĨĐŽŶĨŝĚĞŶĐĞŝŶƚĞƌǀĂůƐƐŚŽƵůĚďĞƐĞƉĂƌĂƚĞĚďǇĂĐŽŵŵĂ͘
ͻŽƵŶĚĂƌǇǀĂůƵĞƐƐŚŽƵůĚďĞƉĂĚĚĞĚĂƐŶĞĐĞƐƐĂƌǇƚŽĂĐĐĞƉƚŶĞŐĂƚŝǀĞǀĂůƵĞƐĂŶĚƚŽĂůůŽǁĂůŝŐŶŵĞŶƚŽĨ
ƚŚĞĚĞĐŝŵĂůƉůĂĐĞ͘
ͻŶĞǆĂŵƉůĞŝƐŐŝǀĞŶďĞůŽǁ͗
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WͲǀĂůƵĞƐ͗
ͻWͲǀĂůƵĞƐƐŚŽƵůĚďĞƌĞƉŽƌƚĞĚƚŽƚŚƌĞĞĚĞĐŝŵĂůƉůĂĐĞƐ͕ĞǆĐĞƉƚǀĂůƵĞƐфϭ͘ϬϬϬďƵƚхϬ͘ϵϵϵǁŝůůďĞƉƌĞƐĞŶƚĞĚ
ĂƐ͚хϬ͘ϵϵϵ͛;Ğ͘Ő͕͘Ϭ͘ϵϵϵϴŝƐƉƌĞƐĞŶƚĞĚĂƐхϬ͘ϵϵϵͿ͖ĂŶĚǀĂůƵĞƐфϬ͘ϬϬϭǁŝůůďĞƉƌĞƐĞŶƚĞĚĂƐ͚фϬ͘ϬϬϭ͛;Ğ͘Ő͕͘
Ϭ͘ϬϬϬϵŝƐƉƌĞƐĞŶƚĞĚĂƐфϬ͘ϬϬϭͿ͘ZŽƵŶĚŝŶŐǁŝůůďĞĂƉƉůŝĞĚĂĨƚĞƌƚŚĞфϬ͘ϬϬϭĂŶĚхϬ͘ϵϵϵƌƵůĞ
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ZĂƚŝŽƐ͗
ͻZĂƚŝŽƐƐŚŽƵůĚďĞƌĞƉŽƌƚĞĚƚŽŽŶĞŵŽƌĞĚĞĐŝŵĂůƉůĂĐĞƚŚĂŶƚŚĞŽƌŝŐŝŶĂůĚĂƚĂ͘


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ͻ/ĨĂĚŝĨĨĞƌĞŶƚĐŽƵŶƚŽƚŚĞƌƚŚĂŶƚŚĞƉŽƉƵůĂƚŝŽŶĐŽƵŶƚŝƐƵƐĞĚĨŽƌĂĚĞŶŽŵŝŶĂƚŽƌ;ǁŝƚŚŝŶƚŚĞƚĂďůĞͿƚŽ
ĐĂůĐƵůĂƚĞƉĞƌĐĞŶƚĂŐĞƐ͕ƚŚĞƌĞƐŚŽƵůĚďĞĂƌŽǁŝŶƚŚĞƚĂďůĞƚŚĂƚŝĚĞŶƚŝĨŝĞƐƚŚĂƚŶƵŵďĞƌ͞Ŷ͘͟
ͻůƚĞƌŶĂƚŝǀĞůǇ͕ĂĨŽŽƚŶŽƚĞƐŚŽƵůĚďĞŝŶĐůƵĚĞĚŝŶĞĂĐŚƚĂďůĞǁŝƚŚƉĞƌĐĞŶƚĂŐĞƐƚŽŝŶĚŝĐĂƚĞƚŚĞ
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DŝƐƐŝŶŐǀĂůƵĞƐ
ͻ͞Ϭ͟ƐŚŽƵůĚďĞƵƐĞĚƚŽŝŶĚŝĐĂƚĞĂǌĞƌŽĨƌĞƋƵĞŶĐǇ͘
ͻďůĂŶŬǁŝůůďĞƵƐĞĚƚŽŝŶĚŝĐĂƚĞŵŝƐƐŝŶŐĚĂƚĂŝŶĂŶĞŶĚͲŽĨͲƚĞǆƚƚĂďůĞŽƌƐƵďũĞĐƚůŝƐƚŝŶŐ͘
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'ƌĂƉŚŝĐƐDĞƚĂĨŝůĞ;'DͿĨŽƌŵĂƚƚĞĚŐƌĂƉŚŝĐĂůŽƵƚƉƵƚŐĞŶĞƌĂƚĞĚďǇ^^͘
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ͻdŚĞŝŵĂŐĞƐŚŽƵůĚďĞĐůĞĂƌĂŶĚŽĨŚŝŐŚƋƵĂůŝƚǇǁŚĞŶǀŝĞǁĞĚŝŶƚŚĞtŽƌĚĚŽĐƵŵĞŶƚ͕ĂŶĚǁŚĞŶƉƌŝŶƚĞĚ͘
ͻ/ŶŐĞŶĞƌĂů͕ďŽǆĞƐĂƌŽƵŶĚƚŚĞĨŝŐƵƌĞƐƐŚŽƵůĚďĞƵƐĞĚ͘
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ͻĐŽŶƚŝŶƵŽƵƐůŝŶĞŽĨƵŶĚĞƌƐĐŽƌĞƐ;͚ͺ͛ͿǁŝůůĨŽůůŽǁƚŚĞďŽĚǇŽĨƚŚĞƚĂďůĞŽƌůŝƐƚŝŶŐƉƌŝŽƌƚŽĂŶǇĨŽŽƚŶŽƚĞƐ
ĂƚƚŚĞďŽƚƚŽŵŽĨƚŚĞƉĂŐĞ
ͻdĂďůĞĨŽŽƚŶŽƚĞƐƐŚŽƵůĚďĞĚĞĨŝŶĞĚƵƐŝŶŐĐŽŵƉƵƚĞƐƚĂƚĞŵĞŶƚƐŝŶƚŚĞƉƌŽĐƌĞƉŽƌƚ͕ĂŶĚƐŚŽƵůĚĂƉƉĞĂƌ
ĚŝƌĞĐƚůǇĂĨƚĞƌƚŚĞďŽĚǇŽĨƚŚĞƚĂďůĞ
ͻdŚĞƉƌŽŐƌĂŵƉĂƚŚĂŶĚŶĂŵĞĂŶĚǀĞƌƐŝŽŶŶƵŵďĞƌ;ŝĨĂƉƉůŝĐĂďůĞͿƐŚŽƵůĚĂƉƉĞĂƌĂƐĨŽŽƚŶŽƚĞϭĂƚƚŚĞ
ďŽƚƚŽŵŽĨƚŚĞƉĂŐĞ
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ͻ&ŽŽƚŶŽƚĞƐƐŚŽƵůĚďĞůĞĨƚͲĂůŝŐŶĞĚ͘
ͻ&ŽŽƚŶŽƚĞƐƐŚŽƵůĚďĞŝŶƐĞŶƚĞŶĐĞĐĂƐĞ͘
ͻKŶůǇ͞ƚǇƉĞǁƌŝƚĞƌ͟ƐǇŵďŽůƐĂƌĞƉĞƌŵŝƚƚĞĚʹĞŐ͞Ύ͕͟͞Ψ͕͟͞η͕͟͞Λ͕͟͞Θ͟ĂŶĚ͞н͘͟
ͻdŚĞĐŚŽŝĐĞŽĨĨŽŽƚŶŽƚĞƐǇŵďŽůƐƐŚŽƵůĚďĞĐŽŶƐŝƐƚĞŶƚ͘͘Ő͘ŝĨǇŽƵŚĂǀĞƚŚĞĨŽŽƚŶŽƚĞ͞ηŝŶĚŝĐĂƚĞƐůĂƐƚ
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ĂůůƚĂďůĞƐ͘
ͻ/ĨƚĞǆƚǁƌĂƉƐĂĐƌŽƐƐŵŽƌĞƚŚĂŶŽŶĞůŝŶĞ;ĨŽƌĂŶŽƚĞͿ͕ƚŚĞĨŝƌƐƚůĞƚƚĞƌĨŽƌĂůůůŝŶĞƐŽĨƚĞǆƚĂĨƚĞƌƚŚĞĨŝƌƐƚŽŶĞ
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Esperion Therapeutics, Inc. 
Dec 17, 2018 
Protocol: ETC-1002-048 
Addendum to Statistical Analysis Plan 
 
Confidential 
Page 1 of 2 
 
 
Addendum to Statistical Analysis Plan 
Title: 
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 
PARALLEL GROUP, MULTICENTER STUDY TO EVALUATE 
THE EFFICACY AND SAFETY OF BEMPEDOIC ACID (ETC-
1002) 180 MG/DAY AS ADD-ON TO EZETIMIBE THERAPY IN 
PATIENTS WITH ELEVATED LDL-C ON LOW DOSE OR LESS 
THAN LOW DOSE STATINS 
Protocol: 
ETC-1002-048 
Clinical Phase: 
3 
Product: 
ETC-1002 
Date: 
Dec 17, 2018  
 
 
 


 
Esperion Therapeutics, Inc. 
Dec 17, 2018 
Protocol: ETC-1002-048 
Addendum to Statistical Analysis Plan 
 
Confidential 
Page 2 of 2 
 
Addendum to the Statistical Analysis Plan for Study 1002-048 
Ad-hoc Analyses 
 
Esperion completed the planned analysis as described in Study 1002-048 SAP for all data 
collected in the study. After the review of the results, it was suggested by the internal 
clinical team that a waterfall plot was generated to visually show percent change from 
baseline in Low Density Lipoprotein Cholesterol (LDL-C) Percent for the different 
treatment groups. 
The waterfall plot was not included in the CSR, but may be included in communications 
with the regulatory agencies for the NDA/MAA submissions. 
 
The Figure for Study 1002-048 Post-hoc Analyses.  
Figure 14.2.5 
Low Density Lipoprotein Cholesterol (LDL-C) Percent Change from 
Baseline to Week 12 / 
Full Analysis Set