Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Farnesoid X receptor NASH Nonalcoholic Steatohepatitis NAFLD Nonalcoholic Fatty Liver Disease FXR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 101
Healthy volunteers: no

Brief summary:
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.

Detailed description:

Arms:
arm 1: Orally administered. arm 2: Orally administered. arm 3: Orally administered. arm 4: Orally administered.

Interventions: intervention 1: TERN-101 intervention 2: Placebo
Intervention descriptions: intervention 1: Investigational drug intervention 2: Matching placebo

Protocol document:
Prot_000.pdf: 
 
CLINICAL STUDY PROTOCOL
Protocol Title:  
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 
Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, 
Tolerability, Efficacy, and Pharmacokinetics of Orally Administered 
TERN-101 Tablets in Adult Patients with Presumed Non-Cirrhotic 
Non-Alcoholic Steatohepatitis (NASH) 
Protocol Number:  
TERN101-2001 
Protocol Version:  
Amendment 1 
Version Date:  
22 May 2020 
Supersedes:  
Original; 26 February 2020 
Compound:  
TERN-101 
Study Phase:  
2a 
Sponsor Name:  
Terns, Inc.  
Legal Registered 
Address:  
1065 E. Hillsdale Blvd. Suite 100 
Foster City, California 94404 
Regulatory Agency 
Identifier Number(s) 
 
US FDA IND:   
 
CONFIDENTIAL 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Terns, Inc. 










Protocol TERN101-2001 
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1. 
Protocol Summary 
1.1. 
Synopsis 
Protocol Title:  
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a 
Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally 
Administered TERN-101 Tablets in Adult Patients with Presumed Non-Cirrhotic Non-Alcoholic 
Steatohepatitis (NASH) 
  
 
 
 
 
 
 
 
 
 
Objectives:  
Primary Objective:  
x To evaluate safety and tolerability of 3 doses of orally administered TERN-101 versus 
placebo for 12 weeks in non-cirrhotic presumed NASH patients, with clinical or 
histological NASH diagnosis  
Secondary Objectives: 
x To evaluate the change in alanine aminotransferase (ALT) with 3 doses of TERN-101 for 
12 weeks versus placebo in non-cirrhotic presumed NASH patients  
x To evaluate the pharmacokinetics (PK) of 3 doses of TERN-101 in non-cirrhotic 
presumed NASH patients  


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Exploratory Objectives:  
x To assess the effect of 3 doses of TERN-101 on liver fat content (LFC) and additional 
indicators of NASH disease activity 
x To evaluate FXR target engagement of 3 doses of TERN-101 in non-cirrhotic presumed 
NASH patients  
x To evaluate the effect of 3 doses of TERN-101 on biomarkers of liver fibrosis 
Endpoints:  
Primary Endpoint:  
x Overall safety assessed by adverse events (AEs) including treatment emergent AEs 
(TEAEs), and proportion of patients with treatment-emergent clinical safety laboratory 
abnormalities 
Secondary Endpoints:  
x Percent change from baseline in ALT levels at 12 weeks 
x Plasma PK for 
 TERN-101 
 
Exploratory Endpoints:  
x Change from baseline in LFC by magnetic resonance imaging-proton density fat fraction 
(MRI-PDFF)  
x Change from baseline in gamma-glutamyl transpeptidase (GGT) 
x Change from baseline in aspartate aminotransferase (AST)  
x Change from baseline in FGF-19  
x Change from baseline in 7-Į-C4 
x Change from baseline in NASH/fibrosis blood biomarkers  
x 
 
Overall Design:  
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. 


Protocol TERN101-2001 
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Version: Amendment 1 
Version Date: 22 May 2020 
 
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Approximately 96 clinically or histologically diagnosed adult non-cirrhotic presumed NASH 
patients who meet study eligibility criteria will be enrolled and randomized at an overall ratio of 
1:1:1:1 into 4 groups receiving 5 mg (n = 24), 10 mg (n = 24), 15 mg (n = 24) TERN-101 tablets, 
or matching placebo (n = 24) orally once daily.  
Of the 96 patients randomized, 24 patients will take part in an intensive PK and 
pharmacodynamic (PD) collection after the first dose and after the last dose of study drug. This 
includes 6 patients at each TERN-101 dose level, and 6 patients in the placebo group. Patients 
who are not participating in the PK/PD sub-study will have trough PK/PD sampling only.  
The total duration of study participation will be approximately 24 weeks, consisting of an 8-
week Screening Period, a 12-week Treatment Period and a 4-week Follow-up Period.  
Disclosure Statement:  
This is a parallel-group treatment study.  
Number of Patients: 
Approximately 96 patients will be randomly assigned to treatment with TERN-101 tablet or 
matching placebo. 
Patients who are randomized but do not receive study drug for any reason may be replaced.  
Study Centers Planned:  
Approximately 40 centers in the United States. 
Intervention Groups and Duration: 
The total study duration will be approximately 24 weeks, consisting of an 8-week Screening 
Period, a 12-week Treatment Period and a 4-week Follow-up Period.  
Screening Period 
The 8-week Screening Period initiates upon signing an Informed Consent, at which point 
eligibility criteria will be reviewed. Each eligible patient will be scheduled for Week 0/Day 1.  
Treatment Period 
The 12-week double-blind, randomized Treatment Period will initiate at Week 0/Day 1 after 
confirming eligibility. The blinded study drug (TERN-101 tablet or placebo) will be orally 
administered once daily in the morning, without regard to food.  


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Version Date: 22 May 2020 
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Patients will return to the site at Weeks 2, 4, 6, 8, and 12 for safety and laboratory assessments. 
Study drug will be dispensed at Week 0/Day 1, Week 4, and Week 8. Week 12 is the last day of 
treatment.  
Intensive PK/PD sampling will be performed in 24 patients participating in the PK/PD sub-study
after the first dose (Week 0/Day 1) and after the last dose of study drug (Week 12).  
Imaging (MRI-PDFF) will be completed at Week 0, Week 6, and Week 12. An MRI is 
performed at early termination (ET) only if not done within the prior 4 weeks, and the patient has 
had at least 4 weeks of dosing.   
Follow-up Period 
All patients will return to site for follow up safety assessments at Week 16. 
If study drug is permanently discontinued for any reason outlined in Section 7, the patient will be 
encouraged to remain in the study to be evaluated during the Follow-Up Period. See the 
Schedule of Activities for data to be collected at the time of discontinuation of study drug and 
follow-up, and for any further evaluations that need to be completed. 
1.2.
Schema
Abbreviations: MRI-PDFF = magnetic resonance imaging proton density fat fraction; PK/PD = 
pharmacokinetics/pharmacodynamics; QD = once a day


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1.3. 
Schedule of Activities (SoA) 
 
Screening 
Treatment Periode  
Follow-
Upb  
ETa 
Notes 
Visit 
Screening 
Week 
0  
Week 
2 
Week 
4 
Week 
6 
Week 
8 
Week 
12 
Week 
16 
 
 
Study Day 
-56 to Day 
-1 
Day 1 
15 
29 
43 
57 
85 
113 
 
Visit windows post randomization through Week 12: ± 
3 days from the specified study day. Visit window 
Week 16: -1 week /+2 days from the specified study 
day. 
Procedures 
Written 
Informed 
Consent 
X 
 
 
 
 
 
 
 
 
Written informed consent may be obtained via 
telephone in accordance with Section 10.1.2. 
Screening may be initiated via telephone to avoid a 
visit to the site, if the patient is disqualified based on 
medical history. 
Patient Fasting 
X 
X 
 
X 
 
X 
X 
X 
X 
Patients must be in fasted state for at least 8 hours 
prior to blood collection and treatment administration 
where applicable. 
Randomization  
 
X 
 
 
 
 
 
 
 
 
Review 
Inclusion and 
Exclusion 
Criteria 
X 
X 
 
 
 
 
 
 
 
Recheck clinical status before randomization and first 
dose of study drug.  
Demographics 
X 
 
 
 
 
 
 
 
 
Includes age, sex, and race/ethnicity.  
Height and 
Weight 
X 
X 
 
X 
X 
X 
X 
X 
X 
Height and weight are collected at Screening and will 
be used to calculate BMI for eligibility. Waist 
circumference is also measured at Screening. Only 
weight is collected Week 0, 4, 6, 8, 12, 16, and ET.    
Medical history  
X 
 
 
 
 
 
 
 
 
Includes details of illnesses and allergies, date(s) of 
onset, whether condition(s) is currently ongoing, and 
medication history, including alcohol use. 
Physical 
Examination 
X 
X 
X 
X 
X 
X 
X 
X 
X 
A complete physical examination will be performed at 
Screening and Week 16. A targeted physical 
examination will be performed at all other visits. 










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f In the event of symptoms suggestive of COVID-19, ad hoc testing (including molecular test such as PCR or viral antigen serology, and/or antibody testing, 
once available via the central laboratory), may be completed at Investigator’s discretion. 
g If a patient is required to be quarantined due to active infection of COVID-19 or exposure to COVID-19, or is otherwise unable to visit the site due COVID-19, 
study drug may be mailed to the patient or made available via another appropriate mechanism (ie, curbside pickup, etc.). 
Abbreviations: AE = adverse event; ALT = alanine transaminase; AST = aspartate transaminase; BMI = body mass index; CK18 = cytokeratin-18; COVID-19 = 
coronavirus disease 2019; CTCAE = common terminology criteria for adverse events; ECG = electrocardiogram; ET = early termination; eGFR = estimated glomerular 
filtration rate; FSH = follicle stimulating hormone; HA = hyaluronic acid; HbA1c = hemoglobin A1c; HBsAG = hepatitis B surface antigen; HCV = hepatitis C virus; 
HIV = human immunodeficiency virus; hsCRP = high sensitivity C-reactive protein; INR = international normalized ratio; IWRS = interactive web response system; 
MRI = magnetic resonance imaging; NCI =  National Cancer Institute; PCR = polymerase chain reaction; PD = pharmacodynamics; PIIINP = Procollagen III N-Terminal 
Propeptide; PK = pharmacokinetics; Pro-C3 = released N-terminal pro-peptide of type III collagen; SAE = serious adverse event; TIMP-1 = tissue inhibitor of 
metalloproteinases-1; ULN = upper limit of normal; WOCBP = women of childbearing potential.


Protocol TERN101-2001 
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Version Date: 22 May 2020 
 
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2. 
Introduction 
2.1. 
Overview of Nonalcoholic Steatohepatitis (NASH) and Unmet Need  
This study is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to 
evaluate the safety, tolerability, efficacy, and PK of various doses of TERN-101 in non-cirrhotic 
presumed NASH patients. TERN-101 is a highly selective and potent small molecule agonist of 
FXR in development for the treatment of patients with NASH.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.2. 
Background 
2.2.1. 
TERN-101 and FXR Agonists for Treatment of NASH 
 
 


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TERN-101 is a non-steroidal, synthetic small molecule 
 and is 
formulated for oral administration in capsule or tablet form. TERN-101 is a potent FXR agonist. 
As a selective and potent nonsteroidal, non-bile acid FXR agonist, TERN-101 may offer a 
unique safety and efficacy profile to benefit the NASH patient population. As summarized 


Protocol TERN101-2001 
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below, nonclinical studies and Phase 1 clinical studies of TERN-101 support its potential utility 
as a disease-modifying treatment for NASH. 
2.2.2. 
Summary of Nonclinical Studies 
 
 
 
 
 
  
In mouse NASH models, TERN-101 inhibited 7-DC4 and significantly reduced NAFLD 
activity score (NAS) and liver fibrosis area. NAS was markedly reduced by all doses of TERN-
101 tested (Figure 1, left panel) with an 80% reduction from baseline at 100 mg/kg (mpk). 
Steatosis was reduced to healthy control (lean mice) levels at 30 mpk (Figure 2, left), and 
hepatocellular ballooning was reduced to healthy control levels at 100 mpk (Figure 2, middle).  
Hepatic inflammation was also reduced in TERN-101 treated mice (Figure 2, right). The 
improvement in liver histology correlated with a reduction in liver triglycerides, serum lipids and 
the liver-related enzymes ALT and AST. These results indicate potent FXR agonist activity and 
support that TERN-101 has the potential for use in the treatment of NASH. 


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Figure 1.  
TERN-101 Reduces NAS and Liver Fibrosis in a NASH Mouse Model   
Obese mice fed a high-fat diet and chronically treated with CCl4 were dosed with varying amounts of TERN-
101 for 28 days. Liver tissue was isolated at end of study and analyzed by histopathology for NAFLD Activity 
Score (NAS, combination of liver steatosis, ballooning and inflammation determined by hematoxylin and eosin 
staining) (left) or liver fibrosis area (sirius red staining) (right).  Data are presented as Mean ± SEM (n=7 for 
TERN-101/100 mpk, n=8 for all other groups; ***p㸺 0.001, **p㸺0.01, *p㸺0.05 vs NASH Control 
(Vehicle); statistics determined by one-way ANOVA followed by Tukey). 
Figure 2.  
TERN-101 Reduces Liver Steatosis, Ballooning, and Inflammation in a 
NASH Mouse Model  
Obese mice fed a high-fat diet and chronically treated with CCl4 were dosed with varying amounts of TERN-
101 for 28 days. Liver tissue was isolated at end of study and analyzed by histopathology for liver steatosis 
(left), ballooning (middle) and inflammation (right) using H&E staining.  Data are presented as Mean ± SEM 
(n=7 for TERN-101/100 mpk, n=8 for all other groups; ***p㸺0.001, **p㸺0.01, *p㸺0.05 vs NASH Control 
(Vehicle); statistics determined by one-way ANOVA followed by Tukey). 






Protocol TERN101-2001 
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Version: Amendment 1 
Version Date: 22 May 2020 
 
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TERN-101 5-mg tablet and at 1.52 hours for TERN-101 25-mg tablet. Transient increases in 
FGF-19 concentrations and dose-dependent decreases in 7-Į-C4 concentrations were observed 
after single doses of TERN-101 tablets. Administration of TERN-101 (5 mg) tablet with food 
delayed the time of maximal plasma concentrations (from ~1 hour fasted to ~4 hours fed) but did 
not result in significant differences in exposure as assessed by AUC. 
 
 
 
 
 
Safety findings from the 4 clinical studies showed that TERN-101 was well-tolerated overall. 
AEs were predominantly mild and transient. The predefined maximum tolerated dose was not 
reached in any study. The overall AE incidence was generally balanced between dose groups. 
Following multiple doses of TERN-101 capsules of up to 400 mg, no TEAEs were attributable to 
TERN-101 on the basis of frequency, dose-relationship, or expected pharmacology. Pruritus was 
not reported by any of the 119 human subjects who have received TERN-101 to date. 
 
 
 
 
 
  No 
transaminase elevations > 1.5 times upper limit of normal were observed in the subsequent 
completed repeat dose study (TERN101-US-A101) 
 or Study TERN101-US-A104). In the 2 completed repeat dose Phase 1 TERN-101 
studies, no consistent trends in changes from baseline in LDL cholesterol were observed with 
TERN-101. In the recently completed Phase 1 study TERN101-US-A104, there was no 
consistent pattern of LDL change on-study; several subjects had elevated levels prior to dosing, 
and LDL remained at overall similar levels on-study. 
Additional information on available TERN-101 clinical study results, including clinical 
pharmacology and dose-selection considerations, is provided in the Investigator’s Brochure. 
2.3. 
Benefit/Risk Assessment 
 
 
 


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The protocol has been designed to minimize the risk to patients. Patients will be monitored to 
detect AEs during the study and will be followed appropriately to ensure resolution of AEs. 
Standard hematology, chemistry, and lipid levels will be obtained and monitored for 
abnormalities in a blinded fashion.  
Overall, based on past experience of clinical studies of TERN-101 in healthy volunteers, the 
benefit/risk assessment is considered to be positive for patients to be enrolled in this study. More 
detailed information about the known and expected benefits and risks and reasonably expected 
adverse events of TERN-101 may be found in the Investigator’s Brochure. 


Protocol TERN101-2001 
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Version: Amendment 1 
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3. 
Objectives and Endpoints 
Objectives:  
Primary Objective:  
x To evaluate safety and tolerability of 3 doses of orally administered TERN-101 versus 
placebo for 12 weeks in non-cirrhotic presumed NASH patients, with clinical or 
histological NASH diagnosis  
Secondary Objectives: 
x To evaluate the change in ALT with 3 doses of TERN-101 for 12 weeks versus placebo in 
non-cirrhotic presumed NASH patients 
x To evaluate the PK of 3 doses of TERN-101 in non-cirrhotic presumed NASH patients 
Exploratory Objectives:  
x To assess the effect of 3 doses of TERN-101 on LFC and additional indicators of NASH 
disease activity  
x To evaluate FXR target engagement of 3 doses of TERN-101 in non-cirrhotic presumed 
NASH patients 
x To evaluate the effect of 3 doses of TERN-101 on biomarkers of liver fibrosis 
Endpoints:  
Primary Endpoint:  
x Overall safety assessed by AEs including TEAEs, and proportion of patients with 
treatment-emergent clinical safety laboratory abnormalities 
Secondary Endpoints:  
x Percent change from baseline in ALT levels at 12 weeks 
x Plasma PK for 
 TERN-101 
 
Exploratory Endpoints:  
x Change from baseline in LFC by MRI-PDFF  
x Change from baseline in GGT  


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x Change from baseline in AST  
x Change from baseline in FGF-19  
x Change from baseline in 7-Į-C4  
x Change from baseline in NASH/fibrosis blood biomarkers  
 
 


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4. 
Study Design 
4.1. 
Overall Design 
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. 
Approximately 96 clinically or histologically diagnosed adult non-cirrhotic presumed NASH 
patients who meet study eligibility criteria will be enrolled and randomized at an overall ratio of 
1:1:1:1 into 4 groups receiving 5 mg (n = 24), 10 mg (n = 24), 15 mg (n = 24) TERN-101 tablet 
or matching placebo (n = 24) orally once daily.  
Of the 96 patients randomized, 24 patients will take part in an intensive PK and PD collection 
after the first dose and after the last dose of study drug. This includes 6 patients at each 
TERN-101 dose level, and 6 patients in the placebo group. Patients who are not participating in 
the PK/PD sub-study will have trough PK/PD sampling only.  
The total study duration will be approximately 24 weeks, consisting of an 8-week Screening 
Period, a 12-week Treatment Period and a 4-week Follow-up Period.  
4.2. 
Scientific Rationale for Study Design 
The study will enroll male and female patients with non-cirrhotic presumed NASH in order to 
obtain evidence of safety, preliminary efficacy, PK, and PD of 3 dose levels of TERN-101. The 
multiple-dose design of this study is randomized and double-blinded to minimize bias and to 
enable efficient evaluation of different dose levels. The placebo control is included to facilitate 
identification of effects related to administration of TERN-101 rather than the study procedures, 
disease, or situation. The study duration will allow characterization of the safety and tolerability 
of TERN-101 with 12 weeks of dosing as well as initial assessment of effect of TERN-101 on 
efficacy parameters in a NASH population. 
4.3. 
Justification for Dose 
Based on PK results from TERN101-US-A104 Phase 1 study in healthy subjects, the tablet 
formulation of TERN-101 was dose linear in the range of 5 mg to 25 mg, with AUC0-t of  
475 (±161) ng*hr/mL and 2890 (±720) ng*hr/mL for 5 and 25 mg tablets, respectively. 
 
 
Evidence of FXR target engagement was seen for doses ranged from 5 mg to 
25 mg tablets of TERN-101 (see Section 2.2.3). The doses selected for this study of 5 mg, 
10 mg, and 15 mg TERN-101 tablets are expected to achieve FXR target engagement and will 
allow for characterization of the safety and efficacy of TERN-101 across these dose levels. 
There was no significant impact of food intake on TERN-101 PK based on results from 
Study TERN101-US-A104, thus TERN-101 can be dosed without regard to food intake.  


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5. 
Study Population 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion Criteria 
Patients are eligible to be included in the study only if all of the following criteria apply: 
1. Must be 18 to 75 years of age inclusive, at the time of signing the informed consent 
 
 
 
3. 2YHUZHLJKW RU REHVH ZLWK D ERG\ PDVV LQGH[ %0,   NJP2 
4. NASH by clinical diagnosis or biopsy as follows:  
a. For clinical diagnosis:  
i. Step 1: Liver stiffness measured by transient elastography of 7.6 - 21 kPa 
and controlled attenuation parameter (CAP) > 300 dB/m within 3 months 
prior to Screening (if results available within this timeframe, assessment 
does not need to be repeated at Screening).  
ii. Step 2: Patients meeting these and all other eligibility criteria will undergo 
MRI-3')) DQG PXVW KDYH OLYHU IDW FRQWHQW   IRU randomization.  
b. For biopsy diagnosis:  
i. Step 1: Fibrotic NASH (NASH CRN F1, F2, or F3) without cirrhosis 
diagnosed by biopsy within 2 years prior to randomization, with no 
subsequent treatment for NASH and stable weight (< 5% weight loss) 
since the time of the biopsy. Results from a previous study biopsy are 
permissible if drug was deemed non-therapeutic or patient received 
placebo.  
ii. Step 2: Patients meeting these and all other eligibility criteria will undergo 
MRI-3')) DQG PXVW KDYH OLYHU IDW FRQWHQW   IRU randomization. 
5. All patients must have: 
x ALT  43 ,8/ IRU PHQ DQG  28 IU/L for women 
x MRI PDFF lLYHU IDW FRQWHQW    


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6. Capable of giving signed informed consent as described in Section 10.1.2, which includes 
compliance with the requirements and restrictions listed in the informed consent form 
(ICF) and in this protocol 
5.2. 
Exclusion Criteria  
Patients are excluded from the study if any of the following criteria apply: 
Medical Conditions 
1. History or clinical evidence of chronic liver diseases other than NAFLD including but not 
limited to: 
x Active hepatitis B defined as positive Hep B surface antigen at screening  
x Active hepatitis C defined as positive Hep C virus (HCV) antibody (anti-HCV) 
and HCV ribonucleic acid (RNA). Patients with anti-HCV but negative HCV 
RNA will be eligible for participation if HCV RNA has been negative for at least 
1 year.  
x Autoimmune liver disease 
x Primary biliary cirrhosis 
x Primary sclerosing cholangitis 
x Wilson’s disease 
x Gilbert’s syndrome if direct bilirubin is above 0.3 mg/dL or evidence of active 
hemolysis  
x Hemochromatosis or other iron overload  
x Alpha-1-antitrypsin deficiency 
x Alcoholic liver disease 
x Prior known drug-induced hepatotoxicity 
x Known bile duct obstruction 
x Suspected or proven liver cancer  
2. History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver 
impairment, including ascites, hepatic encephalopathy, and variceal bleeding 
3. History of liver transplant, or current placement on a liver transplant list 
4. Total bilirubin > 1.2 mg/dL. Note patients with Gilbert syndrome may be enrolled if total 
bilirubin < 2 mg/dL and direct bilirubin  0.3 mg/dL.  
5. Albumin < 3.5 g/dL  
6. INR > 1.1  
7. ALT or AST > 5 × ULN 


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8. Unstable elevated ALT or AST. Patients with ALT or AST > 60 IU/L must have 
evidence of a stable ALT/AST over at least a 2-week time period prior to randomization 
   
 
 
 
 
 
 
 
 
  
9. ALP > 156 IU/L 
10. Platelet count < 150,000 /mm3 
11. eGFR < 60 mL/min/1.73m2  
12. Weight loss of > 5% total body weight within 3 months prior to Screening 
13. History of a malignancy within 2 years of screening, with the following exceptions:  
a) Adequately treated carcinoma in situ of the cervix 
b) Adequately treated basal or squamous cell cancer or other localized non-melanoma 
skin cancer  
14. Uncontrolled diabetes with HbA1c > 9.5%. 
 
 
 
15. Unstable cardiovascular (CV) disease defined as myocardial infarction, unstable angina, 
percutaneous intervention, coronary artery bypass graft, or stroke within 6 months prior 
to randomization 
16. 8QFRQWUROOHG K\SHUOLSLGHPLD GHILQHG DV IDVWLQJ /'/  50 mg/dL despite treatment or 
total triglycerides > 300 mg/dL  
17. QTc > 450 ms for males, > 470 ms for females 
18. Known allergy to study drug  


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20. Average weekly alcohol consumption of > 21 standard drinks for males and > 14 
standard drinks for females over a period of more than 3 consecutive months in the year 
prior to Screening. Remote history of alcoholism with abstinence > 12 months prior to 
Screening and no history of alcoholic liver disease is permissible.  
Note: A standard drink is defined as 12 oz (360 ml) beer, 1.5 oz (45 ml) liquor, or 5 
oz (150 ml) wine.  
21. Illicit substance/chemical abuse in the 12 months prior to Screening 
22. Cannabis use (tetrahydrocannabinol [THC] and cannabidiol [CBD]) within 14 days of 
randomization 
23. Unwilling to abstain from excessive alcohol use (defined in #20 above), cannabis use, 
and illicit substance use during study participation 
24. Contraindications or inability to complete MRI scanning (ie, weight restrictions, presence 
of permanent pacemaker, implanted cardiac devices, etc.) 
25. Positive for human immunodeficiency virus (HIV) infection 
26. Laboratory or clinical evidence of current infection with Severe Acute Respiratory 
Syndrome Coronavirus 2 (SARS-CoV-2), i.e. COVID-19 
27. Presence of any condition that could, in the opinion of the investigator, compromise the 
patient’s ability to participate in the study 
Prior or Anticipated Therapy 
28. Treatment with OCA, other investigational FXR agonists, SLRJOLWD]RQH RU RWKHU 33$5Ȗ
agonists, or high-dose vitamin E (> 400 IU/day) within 3 months prior to Screening. 
Patients treated with vitamin E   ,8GD\ PXVW KDYH EHHQ RQ VWDEOH GRVH IRU DW OHDVW 3 
months prior to Screening and should remain on the same dose during study. Patients 
treated with GLP-1 analogues, DPP-4 inhibitors, and SGLT2 inhibitors must have been 
on a stable dose for at least 3 months prior to Screening and should remain on the same 
dose during study.  
29. Use of medications potentially impacting steatohepatitis within 3 months of 
randomization, including but not limited to systemic corticosteroids (prednisone 
equivalent of > 10 mg/day for > 2 weeks), amiodarone, tamoxifen and methotrexate) 


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30. Initiation of the following medications within 3 months of randomization; or dose 
adjustment expected during study participation:   
x Statins or PCSK9 inhibitors 
x Metformin and other antidiabetic drugs (must have been on stable dose for at least 
2 months before randomization). Note: GLP-1 analogues, DPP-4 inhibitors, and 
SGLT2 inhibitors addressed above. 
x Hormonal contraceptives 
 
 
 
Prior Clinical Study Experience 
32. Participation in another clinical trial within 3 months prior to randomization. 
 
 
 
 
 
 
 
 
 
 
 
5.3.2. 
Meals and Dietary Restrictions 
Patients should arrive at the clinic fasting for assessments and dosing as defined in the Schedule 
of Activities (Section 1.3). This includes at least an 8-hour fast prior to the visit, during which 
food and drink is restricted. Water is allowed ad libitum.  
Patients participating in the PK/PD Sub-Study at (Week 0/Day 1) and Week 12 should arrive at 
the clinic fasting (an 8-hour fast prior to the visit) and restrict food and drink until 2 hours post-
dose. Food and drink may resume after this timepoint. Patients participating in the PK/PD Sub-
Study do not need to be fasting for blood collection at 24, 48, or 72 hours post-dose. 
 
  


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5.3.3. 
Alcohol, Cannabis, and Illicit Drug Use 
Patients must agree to not consume > 21 standard drinks per week for males and > 14 standard 
drinks per week for females. A standard drink is defined as 12 oz (360 ml) beer, 1.5 oz (45 ml) 
liquor, or 5 oz (150 ml) wine.  
Patients must abstain from THC (cannabis) and illicit drug use during study participation.  
Patients must abstain from CBD use during study participation. Short term topical CBD use (< 
14 days) is acceptable.   
5.4. 
Screen Failures 
Screen failures are defined as patients who consent to participate in the clinical study but are not 
subsequently randomized. A minimal set of screen failure information is required and will be 
documented to ensure transparent reporting of screen failure patients to meet the Consolidated 
Standards of Reporting Trials (CONSORT) publishing requirements and to respond to queries 
from regulatory authorities. Minimal information includes demography, screen failure details, 
eligibility criteria, and any serious adverse event (SAE). 
Any patient who screen fails due to SARS-CoV-2 testing or clinical status may re-screen at the 
discretion of the Investigator once SARS-CoV-2 infection has resolved. Any other requests for 
re-screening must be discussed with the Sponsor.  




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6.4. 
Measures to Minimize Bias: Randomization and Blinding 
Patients will be randomized to TERN-101 or placebo using an Interactive Web Response System 
(IWRS). Before the study is initiated, the log-in information and directions for the IWRS will be 
provided to each site.  
Approximately 96 patients will be randomized at an overall ratio of 1:1:1:1 into 4 groups 
receiving 5 mg (n = 24), 10 mg (n = 24), 15 mg (n = 24) TERN-101 tablet, or matching placebo 
(n = 24). Randomization will ensure 6 patients at each TERN-101 dose level and 6 patients in the 
placebo group are assigned to the PK/PD sub-study. 
Investigators, patients, all study personnel, and the Sponsor will remain blinded to each patient’s 
assigned dose group throughout the course of the study. Study drug will be dispensed at the 
study visits as summarized in Schedule of Activities. Returned study drug should not be re-
dispensed to patients.  
6.4.1. 
Unblinding  
Treatment assignment may be unblinded if knowing the patient’s treatment assignment would 
affect immediate medical management of the patient. The IWRS will be programmed with blind-
breaking instructions. In case of an emergency, the Investigator has the sole responsibility for 
determining if unblinding of a patient’s intervention assignment is warranted. Patient safety must 
always be the first consideration in making such a determination. If the Investigator decides that 
unblinding is warranted, the Investigator should make every effort to contact the Sponsor prior to 
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the patient. If a patient’s intervention assignment is unblinded, the Sponsor must be notified 
within 24 hours after breaking the blind. The date and reason that the blind was broken must be 
recorded in the source documentation and case report form, as applicable. 
Any unblinding of Sponsor personnel for expedited reporting of suspected unexpected serious 
adverse reactions (SUSARs) or other reasons will be addressed in a separate plan.  
6.4.2. 
Patient Enrollment and Study Drug Assignment 
It is the responsibility of the Investigator to ensure that patient eligibility is confirmed prior to 
randomization. Documentation of the personally signed and dated informed consent of each 
patient, using the study-specific ICF, is required before initiating the Screening Period.  
After written informed consent has been obtained, the patient’s identification number will be 
obtained from the IWRS. Once eligibility to participate has been established, the randomized 
treatment assignment will be obtained from the IWRS. 
6.5. 
Study Drug Compliance 
Patients will be dispensed study during their study visits and will self-administer study drug at 
home. Compliance will be assessed 
 
 
   
 
 
 
 
 
 
6.6. 
Concomitant Therapy 
Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, 
and/or herbal supplements) that the patient is receiving at the time of randomization or receives 
during the study must be recorded at each study visit along with: 
x Reason for use 
x Dates of administration including start and end dates 
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Medications prohibited for use within 3 months of randomization and through the end of the 
study:  
x Medications with potential impact on NASH outcome, including OCA, other 
investigational FXR agonists, pioglitazone or other 33$5Ȗ DJRQLVWV or high-dose vitamin 
E (> 400 IU/day).   
o 3DWLHQWV WUHDWHG ZLWK YLWDPLQ (   ,8GD\ PXVW KDYH EHHQ RQ VWDEOH GRVH IRU DW
least 3 months prior to screening and should remain on the same dose during 
study.  
o Patients treated with GLP-1 analogues, DPP-4 inhibitors, and SGLT2 inhibitors 
must have been on a stable dose for at least 3 months prior to screening and 
should remain on the same dose during study. 
x Medications potentially impacting steatohepatitis, including but not limited to systemic 
corticosteroids (prednisone equivalent of > 10 mg/day for > 2 weeks), amiodarone, 
tamoxifen and methotrexate. Use of systemic corticosteroids for < 2 weeks within 
3 months prior to randomization and while on study is allowed.  
  
 
 
  


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Medications allowed with steady use if initiated at least 3 months before randomization, with 
expectation of no dose adjustment during study participation:  
x Statins or PCSK9 inhibitors 
x Metformin and other diabetic drugs (must have been on stable dose for at least 2 months 
before randomization). Note: GLP-1 analogues, DPP-4 inhibitors, and SGLT2 inhibitors 
addressed above.  
x Hormonal contraceptives 
The Medical Monitor should be contacted if there are any questions regarding concomitant 
therapy. Any dose adjustments that may be required during study participation should be 
discussed with the Medical Monitor. 
6.7. 
Dose Modifications 
Dose modifications of study drug are not permitted.  
6.8. 
Dose Interruptions 
On all non-study visit days, patients will self-administer the study drug orally once daily in the 
morning, without regard to food. 
 
 
  
 
 
 
 
 
  
 
 
 
6.8.1. 
Dose Interruptions due to COVID-19 
If a patient requires home quarantine due to SARS-CoV-2 infection or exposure, or due to 
COVID-19 symptoms, the patient may continue study drug provided that appropriate safety 
follow-up is possible and that hospitalization is not required. Home health care visits may be 
made available to continue study assessments in the patient’s home where feasible, and/or 
remote visits via telephone, telemedicine, or other appropriate virtual communication may be 
substituted for a visit to the site. Sites should discuss the mechanism for safety follow-up with 
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If a patient has symptoms of COVID-19 requiring hospitalization, study drug must be 
discontinued during hospitalization. A case-by-case assessment of whether to resume study drug 
can be done upon discharge. Dosing should not be resumed without consultation with the 
Medical Monitor. The patient should be encouraged to remain in the study to be evaluated during 
the Follow-Up Period.  
6.9. 
Intervention after the End of the Study 
No further interventions are planned after the end of the study.  


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7. 
Discontinuation of Study Drug and Patient Discontinuation or 
Withdrawal 
7.1. 
Discontinuation of Study Drug 
  
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
If study drug is permanently discontinued, the patient will remain in the study to be evaluated 
during the Follow-Up Period. See the Schedule of Activities for data to be collected at the time 
of discontinuation of study drug and follow-up and for any further evaluations that need to be 
completed. 


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7.2. 
Patient Discontinuation/Withdrawal from the Study 
A patient may withdraw from the study at any time at his/her own request, or may be withdrawn 
at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons.  
 
 
 
 
 
 
 
7.3. 
Lost to Follow up 
A patient will be considered lost to follow-up if he or she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site. 
 
 
 
 
 
 
 
 
 
 
 
 
  
 


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8. 
Study Assessments and Procedures 
Study procedures and their timing are summarized in the Schedule of Activities. Protocol 
waivers or exemptions are not allowed. 
Adherence to the study design requirements, including those specified in the Schedule of 
Activities, is essential and required for study conduct. 
All screening evaluations must be completed and reviewed to confirm that potential patients 
meet all eligibility criteria. The investigator will maintain a screening log to record details of all 
patients screened and to confirm eligibility or record reasons for screening failure, as applicable. 
The maximum amount of blood collected from each patient over the duration of the study is not 
expected to exceed 550 mL. Repeat or unscheduled samples may be taken for safety reasons or 
for technical issues with the samples. 
If a patient requires home quarantine due to SARS-CoV-2 infection or exposure, or due to 
COVID-19 symptoms or other associated concern with attending an in-person study visit, in 
accordance with Section 6.8.1, home health care visits may be made available to continue study 
assessments in the patient’s home where feasible, and/or remote visits via telephone, 
telemedicine, or other appropriate virtual communication may be substituted for a visit to the 
site. 
8.1. 
Study Assessments 
Planned time points for all safety assessments are provided in the Schedule of Activities.  
8.1.1. 
Demographics 
Demographic data includes age, sex, and race/ethnicity.  
8.1.2. 
Height and Weight 
Height and weight are collected at Screening and will be used to calculate BMI for eligibility. 
Waist circumference is also measured at Screening. Only weight is collected at Weeks 0, 4, 6, 8, 
12, 16, and ET.   
 
 
 
 
 
 


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8.1.3. 
Medical History 
Medical history, including details of illnesses and allergies, date(s) of onset, whether condition(s) 
is currently ongoing, and medication history, including alcohol use, will be collected for all 
patients at Screening.  
8.1.4. 
Physical Examinations 
A complete physical examination will include assessments of general appearance, 
cardiovascular, respiratory, abdomen, head and neck (including ears, eyes, nose and throat), 
lymph nodes, thyroid, and musculoskeletal systems.  
A targeted physical examination will be conducted to evaluate reported current or prior AEs, 
symptoms reported by the patient, or abnormal laboratory readouts.  
 
8.1.5. 
Vital Signs 
Temperature, pulse rate, respiratory rate, and blood pressure will be assessed and maintained in 
source documentation.  
Blood pressure and pulse measurements will be assessed with a completely automated device. 
Manual techniques will be used only if an automated device is not available. 
Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the 
patient in a quiet setting without distractions (eg, television, cell phones). 
8.1.6. 
Electrocardiograms 
Single 12-lead electrocardiograms (ECGs) will be obtained as outlined in the Schedule of 
Activities (see Section 1.3) using an ECG machine that automatically calculates the heart rate 
and measures PR, QRS, and QT intervals. QTc will be calculated using the formula outlined in 
Appendix 4. 
 
 
 
  
8.1.7. 
Clinical Laboratory Assessments 
See Appendix 1 for the list of clinical laboratory tests to be performed and to the Schedule of 
Activities for the timing and frequency. 


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The investigator must review the laboratory report, document this review, and record any AEs 
per the guidance in Appendix 6. The laboratory reports must be filed with the source documents.  
Shifts of clinically significant Grade 3 or Grade 4 laboratory abnormalities or any clinically 
significant laboratory abnormalities considered possibly related to study drug in the opinion of 
the investigator should be repeated within 48-72 hours and followed to resolution or until stable. 
All protocol-required laboratory assessments, as defined in Appendix 1, must be conducted in 
accordance with the laboratory manual and the Schedule of Activities. 
8.1.7.1. 
Liver Function Tests 
In order to be eligible for his study, patients must have an $/7  43 ,8/ IRU PHQ DQG  28 IU/L 
for women. ALT/AST stability may be evaluated prior to randomization per Section 5.  
During the course of the study, LFTs will be monitored per the Schedule of Activities. Refer to 
Appendix 1 for a list of tests to be performed, and to Appendix 3 for additional information on 
criteria for increased liver chemistry monitoring. 
8.1.8. 
Transient Elastography  
Liver stiffness will be assessed by transient elastography at Screening to determine study 
eligibility. If results from transient elastography measurement within 3 months of Screening are 
available, these values can be used to assess eligibility and do not need to be repeated.  
 
 
  
8.1.9. 
MRI-PDFF  
MRI-PDFF will be conducted as specified in the Schedule of Activities. 
Degree of liver steatosis will be measured by MRI-PDFF at Screening. An MRI-PDFF may 
proceed on the basis of the initial screening ALT/AST level, given all other eligibility criteria are 
met, but randomization should not occur prior to confirmation of ALT/AST stability as 
necessary, per Section 5.  
An MRI-PDFF should be performed at ET only if not done within the prior 4 weeks, and the 
patient has had at least 4 weeks of dosing.   
The images will be analyzed by a central reader. MRI-cT1 will be collected along with MRI-
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8.2. 
Pharmacokinetics 
Plasma samples will be collected for measurement of plasma concentrations of study drug as 
specified in the Schedule of Activities and Appendix 2.  
Patients in the PK/PD sub-study will undergo intensive and trough PK sample collection as 
specified in the Schedule of Activities and Appendix 2.  
Patients who are not participating in the PK/PD sub-study will undergo trough PK sampling 
only, as specified in the Schedule of Activities and Appendix 2.  
Instructions for the collection and handling of biological samples will be provided by the 
Sponsor. The actual date and time (24-hour clock time) of each sample will be recorded. 
Samples will be used to evaluate the PK of study drug.
 
 
Drug concentration information that may unblind the study will not be reported to investigative 
sites or blinded personnel until the study has been unblinded. 
 
 
 
8.3. 
Pharmacodynamics 
Plasma samples will be collected for measurement of FGF19, 7-Į-C4, 
 as specified 
in the Schedule of Activities and Appendix 2. 
 
 
Patients in the PK/PD sub-study will undergo intensive PD sample collection for FGF19 and 7-
Į-C4, and trough PD sample collection for 7-Į-C4 
 as specified in the Schedule of 
Activities and Appendix 2.  
Patients who are not participating in the PK/PD sub-study will undergo trough PD sampling only 
for 7-Į-C4 
 as specified in the Schedule of Activities and Appendix 2.  
Instructions for the collection and handling of biological samples will be provided by the 
Sponsor. The actual date and time (24-hour clock time) of each sample will be recorded. 
Samples will be used to evaluate the pharmacodynamics of study drug.
 
 
 


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8.4. 
Biomarkers 
Collection of samples for biomarkers related to NASH is also part of this study. The following 
samples will be collected from all patients in this study as specified in the Schedule of Activities:  
x Blood collection for the following biomarkers: CK-18 (M30 and M65), PIIINP, TIMP-1, 
HA, Pro-C3, 
 
 
 
 
 
 
 
 
 
 
8.5. 
Adverse Events and Serious Adverse Events 
An AE is any untoward medical occurrence in a patient or clinical study patient, temporally 
associated with the use of study drug, whether or not considered related to the study drug.  
An SAE is defined as any untoward medical occurrence that, at any dose, results in the 
following: death; is life threatening; requires in-patient hospitalization; results in persistent 
disability or incapacity; is a congenital anomaly or birth defect; or is a medically important event 
or reaction that may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the patient or may require medical or surgical intervention to prevent one of the 
other outcomes in the definition.  
Events meeting the definition of an AE or SAE are defined in Appendix 6, including details on 
recording, reporting, and follow-up of AEs and SAEs, assessment of intensity, and assessment of 
causality. AEs will be reported by the patient (or, when appropriate, by a caregiver, surrogate, or 
the patient's legally authorized representative) at every study visit. 


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The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible for following 
up AEs that are serious, considered related to the study drug or study procedures, or that caused 
the patient to discontinue the study drug (see Section 7). 
8.5.1. 
Time Period and Frequency for Collecting AE and SAE Information 
After informed consent but prior to initiation of study drug, the following types of events should 
be reported: all AEs and SAEs related to protocol-mandated procedures.  
Medical occurrences (events considered not related to protocol-mandated procedures) that begin 
before the start of study drug but after obtaining informed consent will be recorded on the 
Medical History/Current Medical Conditions section of the eCRF not the AE section. 
All AEs and SAEs, regardless of cause or relationship, will be collected from the start of study 
drug through the Follow-Up Period, at every study visit, as specified in the Schedule of 
Activities (Section 1.3). 
All SAEs will be recorded and reported to the Sponsor or designee immediately and under no 
circumstance should this exceed 24 hours, as indicated in Appendix 6. The Investigator will 
submit any updated SAE data to the Sponsor within 24 hours of it being available. 
Investigators are not obligated to actively seek reports of AEs or SAEs after conclusion of the 
study participation. However, if the investigator learns of any SAE, including a death, at any 
time after a patient has been discharged from the study, and he/she considers the event to be 
reasonably related to the study drug or study participation, the investigator must promptly notify 
the Sponsor. 
8.5.2. 
Method of Detecting AEs and SAEs 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 6. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the patient is the preferred method to inquire about 
AE occurrences. 
8.5.3. 
Follow-up of AEs and SAEs 
After the initial AE and/or SAE report, the investigator is required to proactively follow each 
patient at subsequent visits/contacts. All SAEs will be followed until resolution, stabilization, the 
event is otherwise explained, or the patient is lost to follow-up (as defined in Section 7.3). 
Further information on follow-up procedures is provided in Appendix 6. 


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8.5.4. 
Regulatory Reporting Requirements for SAEs 
Prompt notification by the investigator to the Sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of patients and the safety of a study 
drug under clinical investigation can be met. 
The Sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study drug under clinical investigation. The Sponsor 
will comply with country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary. 
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the Investigator’s Brochure and will notify the IRB/IEC, if appropriate according to 
local requirements. 
8.5.5. 
Pregnancy 
 
 
 
 
 
8.5.6. 
Assessment of Pruritus 
For patients who report AEs consistent with pruritus, photographs of the affected area(s) will be 
taken at the discretion of the Investigator (eg, if there are visible skin lesions; photos that would 
identify the patient, ie, of the entire face, will be avoided), and a qualified staff member will 
administer the Pruritus Numerical Rating Scale (Appendix 8) at each study visit where pruritus is 
reported or noted to be ongoing. If pruritus is reported, the clinical site will provide details on 
these events in the eCRF.  
The Investigator will be asked to provide an assessment of the severity of the AE using the NCI 
CTCAE v5.0 categories for pruritus as follows:  
x 
Grade 1: Mild or localized; topical intervention indicated.  


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x 
Grade 2: Widespread and intermittent; skin changes from scratching (eg, edema, 
papulation, excoriations, lichenification, oozing/crusts); oral intervention indicated; 
limiting instrumental activities of daily living (ADL).  
x 
Grade 3: Widespread and constant; limiting self-care, ADL, or sleep; systemic 
corticosteroid or immunosuppressive therapy indicated. 
 
For Grade 3 cases, follow up by telephone contact or in person visit should occur within 3 days 
or at the discretion of the Investigator. Additional follow up may take place until symptoms 
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The baseline value is defined to be the latest assessment value prior to the first dose of study 
drug, unless specified in the SAP for some particular tests. 
Missing values will not be imputed. 
Data analysis will be performed using SAS® Version 9.4 or higher. 
SDTM (Study Data Tabulation Model) and Analysis Data Model (ADaM) datasets will be 
prepared using Clinical Data Interchange Standards Consortium (CDISC) SDTM IG Version 3.2, 
ADaM Version 2.1, and CDISC ADaM Implementation Guide Version 1.1.  
9.4.2. 
Primary Endpoints 
Safety parameters will be listed and summarized using descriptive statistics. The safety 
parameters will include AEs, and treatment emergent clinical laboratory parameters. No formal 
statistical testing is planned.  
Reported AEs will be coded using the latest version of Medical Dictionary for Regulatory 
Activities (MedDRA Version 22.1, or most recent) and graded for severity according to NCI 
CTCAE, Version 5.0.  
All TEAEs will be listed and summarized by MedDRA Preferred Term and System Organ Class, 
as well as by maximum intensity and study drug causality, in frequency and percentage. 
Summaries of treatment-emergent SAEs, TEAEs related to study drug, TEAEs resulting in study 
drug discontinuations and death will be produced. 
Grade shifts in laboratory tests will be summarized in addition to AEs. Absolute or relative 
changes from baseline of quantitative measurements will be analyzed by treatment group and 
timepoints and presented in shift tables, if applicable. Laboratory abnormalities will be graded 
according to NCI CTCAE Version 5.0.  
The number and percentage of subjects experiencing treatment-emergent graded lab toxicities 
will be summarized by treatment group and severity grade.  
Further details on the analysis of safety parameters will be provided in the SAP. 
9.4.3. 
 Secondary Endpoints 
9.4.3.1. 
Change from Baseline in ALT Levels at 12 Weeks 
The secondary efficacy variable is the percent change from Baseline in the ALT after 12 weeks 
of treatment in patients treated with either TERN-101 or matching placebo. The mean percent 
change from baseline in ALT in each TERN-101 group will be compared with placebo 
separately without controlling for any family-wise error rate (overall type I error) by using 
analysis of covariance (ANCOVA) methods. The percent change from baseline in ALT will also 




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For the Intensive PD sampling sub-study an ANOVA model will be fit with change from 
baseline as response variable, and baseline value and treatment as fixed effects. 
x Change from baseline in FGF-19 and 7-Į-C4  
x Change from baseline in NASH/fibrosis biomarkers  
 
 
 
 
 
 
MRI-cT1 
 will be addressed in the SAP. 
9.4.4.1. 
PD Endpoints 
 
No formal statistical analysis of PD data is 
planned, however, data may be used for statistical analysis or modeling to evaluate correlation of 
PK and PD parameters, if applicable. These analyses will be defined in the SAP. 
 
  
 
  


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10. 
Regulatory, Ethical, and Study Oversight Considerations 
10.1. 
Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with the following: 
x Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
(CIOMS) International Ethical Guidelines 
x Applicable International Council on Harmonisation (ICH) Good Clinical Practice (GCP) 
Guidelines 
x Applicable laws and regulations 
The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant documents 
(eg., advertisements) must be submitted to an IRB/IEC by the investigator and reviewed and 
approved by the IRB/IEC before the study is initiated. 
Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study patients. 
The investigator will be responsible for the following: 
x Providing written summaries of the status of the study to the IRB/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/IEC 
x Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures 
x Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 Code of Federal Regulations (CFR), ICH guidelines, the IRB/IEC, European 
regulation 536/2014 for clinical studies (if applicable), and all other applicable local 
regulations 
10.1.1. 
Financial Disclosure 
Investigators and sub-investigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing information on financial interests during the course of the study and for 
1 year after completion of the study. 


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10.1.2. 
Informed Consent Process 
The investigator or his/her representative will explain the nature of the study to the patient or 
his/her legally authorized representative and answer all questions regarding the study. 
Patients must be informed that their participation is voluntary. Patients or their legally authorized 
representative will be required to sign a statement of informed consent that meets the 
requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and 
Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study center. 
The medical record must include a statement that written informed consent was obtained before 
the patient was enrolled in the study and the date the written consent was obtained. The 
authorized person obtaining the informed consent must also sign the ICF. 
Patients must be re-consented to the most current version of the ICF(s) during their participation 
in the study. 
A copy of the ICF(s) must be provided to the patient or the patient’s legally authorized 
representative. 
The ICF will contain a separate section that addresses the use of remaining mandatory samples 
for optional exploratory research for up to 15 years after the end of the study. The investigator or 
authorized designee will explain to each patient the objectives of the exploratory research. 
Patients will be told that they are free to refuse to participate and may withdraw their consent at 
any time and for any reason during the storage period. A separate signature will be required to 
document a patient's agreement to allow any remaining specimens to be used for exploratory 
research. Patients who decline to participate in this optional research will not provide this 
separate signature. 
Written informed consent may be obtained via telephone with appropriate documentation of how 
the informed consent form was transmitted to the patient, (such as via email, fax, or mail) and 
how signature was obtained. Screening may be initiated via telephone to avoid a visit to the site 
if the patient is disqualified based on medical history. 
10.1.3. 
Data Protection 
Patients will be assigned a unique identifier by the sponsor. Any patient records or datasets that 
are transferred to the sponsor will contain the identifier only; patient names or any information 
which would make the patient identifiable will not be transferred. 
The patient must be informed that his/her personal study-related data will be used by the sponsor 
in accordance with local data protection law. The level of disclosure must also be explained to 
the patient who will be required to give consent for their data to be used as described in the 
informed consent.  


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Version Date: 22 May 2020 
 
CONFIDENTIAL 
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The patient must be informed that his/her medical records may be examined by Clinical Quality 
Assurance auditors or other authorized personnel appointed by the sponsor, by appropriate 
IRB/IEC members, and by inspectors from regulatory authorities. 
10.1.4. 
Dissemination of Clinical Study Data 
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies) by 
Terns, Inc, as appropriate. Terns, Inc. will ensure that the report meets the standards set out in the 
ICH Guideline for Structure and Content of Clinical Study Reports (ICH E3). Note that an 
abbreviated report may be prepared in certain cases. Public disclosure of study results will be in 
accordance with all applicable laws and ICH guidelines. The posting of company-sponsored 
study information and tabular study results on the US National Institutes of Health’s website 
www.ClinTrials.gov and other publicly accessible sites. 
10.1.5. 
Data Quality Assurance 
All patient data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or electronically 
signing the CRF. 
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the eCRF. 
The investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source data documents. 
Monitoring details describing strategy (eg, risk-based initiatives in operations and quality such as 
Risk Management and Mitigation Strategies and Analytical Risk-Based Monitoring), methods, 
responsibilities and requirements, including handling of noncompliance issues and monitoring 
techniques (central, remote, or on-site monitoring) are available in the Monitoring Plan and site-
specific contracts.  
The sponsor or designee is responsible for the data management of this study including quality 
checking of the data. 
The sponsor assumes accountability for actions delegated to other individuals (eg, Contract 
Research Organizations). 
Study monitors will perform ongoing source data verification to confirm that data entered into 
the eCRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of patients are being protected; and that the study is being 
conducted in accordance with the currently approved protocol and any other study agreements, 
ICH GCP, and all applicable regulatory requirements. 


Protocol TERN101-2001 
Terns, Inc. 
Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 57 of 82 
 
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the investigator until at least 2 years after the last approval of a marketing application 
in an ICH region (ie, United States, Europe, or Japan) and until there are no pending or 
contemplated marketing applications in an ICH region (ie, United States, Europe, or Japan) or at 
least 2 years have elapsed since the formal discontinuation of clinical development of the 
investigational product. These documents should be retained for a longer period however if 
required by the applicable regulatory requirement(s) or if needed by the sponsor. No records may 
be destroyed during the retention period without the written approval of the sponsor. No records 
may be transferred to another location or party without written notification to the sponsor. 
10.1.6. 
Protocol Deviations 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. In the event of a significant deviation related to 
gross non-compliance from the protocol, or events that impose significant risk to patient safety, 
the investigator or designee must notify the Sponsor or designee immediately. Deviations must 
be documented in accordance with the Sponsor’s procedures, and in accordance with any site 
procedures or processes.  
10.1.7. 
Source Documents 
Source documents provide evidence for the existence of the patient and substantiate the integrity 
of the data collected. Source documents are stored at the investigator’s site. 
Data reported on the eCRF or entered in the eCRF that are transcribed from source documents 
must be consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on the 
study.  
The required source data should include notes containing at least the following information for 
each patient:  
x Patient identification (name, date of birth, gender) 
x Documentation that the patient meets eligibility criteria 
x Documentation of the reason(s) a consented patient is not enrolled 
x Participation in study (including study number) 
x Study discussed and date of informed consent 
x Dates of all visits 
x Documentation that protocol specific procedures were performed 


Protocol TERN101-2001 
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Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 58 of 82 
 
x Results of efficacy parameters, as required by the protocol 
x Start and end date (including dose regimen) of study drug administration, including dates 
of dispensation and return as applicable 
x Record of all adverse events and other safety parameters (start and end date, and 
including causality and severity) 
x Concomitant medication (including start and end date, dose if relevant; dose changes) 
x Date of study completion and reason for early discontinuation, if applicable  
10.1.8. 
Study and Site Start and Closure 
The first patient screened is considered the first act of recruitment and will be the study start 
date. 
The sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
x 
Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC 
or local health authorities, the sponsor's procedures, or GCP guidelines 
x 
Inadequate recruitment of patients by the investigator 
x 
Discontinuation of further study drug development 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
Investigators, the IECs/IRBs, the regulatory authorities, and any contract research 
organization(s) used in the study of the reason for termination or suspension, as specified by the 
applicable regulatory requirements. The Investigator shall promptly inform the subject and 
should assure appropriate follow-up care as warranted by the protocol or as medically necessary. 




Protocol TERN101-2001 
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Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 60 of 82 
 
Total Cholesterol 
Triglycerides  
VLDL 
Urinalysis 
x Specific gravity 
x pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, 
leukocyte esterase by dipstick 
x Microscopic examination (if blood or protein is abnormal) 
  
 
Other Tests 
x 
 
x Blood alcohol test1 
x Urine drug screen including amphetamines, barbiturates, cocaine, 
opiates, cannabinoids and benzodiazepines 
x Serology1: HIV antibody, HBsAg, and HCV antibody6 
x COVID-19: SARS-CoV-2 test for active infection (e.g. molecular test 
such as PCR or viral antigen serology), and SARS-CoV-2 Ab test (IgG 
and IgM) 
NOTES: 
1 Only collected at Screening.  
2 Details of liver chemistry increased monitoring criteria are given in Appendix 3.  
3 eGFR to be calculated by central lab; refer to Appendix 5 for the formula. 
4 If total bilirubin is increased above the upper limit of normal there should be a reflex to direct and indirect 
bilirubin, as outlined in Appendix 3. 
5 At Screening, Week 0, and if significant abnormal liver function is observed, as outlined in Appendix 3. 
6 If HCV antibody positive, conduct HCV RNA test.   
Abbreviations:  ȕ-hCG = ȕ-human chorionic gonadotropin; ALP = alkaline phosphatase; ALT = alanine 
transaminase; AST = aspartate transaminase; BUN = blood urea nitrogen; CPK = creatine phosphokinase; eGFR = 
estimated glomerular filtration rate; FSH = Follicle-stimulating hormone GGT = gamma-glutamyl transpeptidase; 
HbA1c = hemoglobin A1c; HBsAG = hepatitis B surface antigen; HCG = human chorionic gonadotropin; HCV = 
hepatitis C virus; HDL = high-density lipoprotein; HIV = human immunodeficiency virus; IgG = immunoglobulin 
G; IgM = immunoglobulin M; LDL = low-density lipoprotein; MCH = mean corpuscular hemoglobin; MCV = 
mean corpuscular volume; PCR = polymerase chain reaction; RBC = red blood cell; RNA = ribonucleic acid; 
SARS-CoV-2 = Severe Acute Respiratory Syndrome Coronavirus 2; VLDL = very low-density lipoprotein; WBC 
= white blood cell; WOCBP = women of childbearing potential 
Investigators must document their review of each laboratory safety report. Shifts of clinically 
significant Grade 3 or Grade 4 laboratory abnormalities or any clinically significant laboratory 
abnormalities considered possibly related to study drug in the opinion of the investigator should 
be repeated within 48-72 hours and followed to resolution or until stable. 
Laboratory/analyte results that could unblind the study will not be reported to investigative sites 
or other blinded personnel until the study has been unblinded. 






Protocol TERN101-2001 
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Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 63 of 82 
 
Appendix 4: Fridericia’s Formula 
A single 12-lead ECG will be obtained as outlined in the Schedule of Activities (see Section 1.3) 
using an ECG machine that automatically calculates the heart rate and measures PR, QRS, and 
QT intervals. QTc will be calculated using Fredericia’s Formula as outlined below.  
The Investigator will review the ECGs for any clinically significant abnormalities.  
Fridericia’s Formula:  
QTc = QT/(RR^0.33) 
http://www.thecalculator.co/health/QTc-Calculator-385.html 
 


Protocol TERN101-2001 
Terns, Inc. 
Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 64 of 82 
 
Appendix 5: Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 
Formula to Estimate Glomerular Filtration Rate  
 
GFR = 141 × min(Scrț Į × max(Scrț -1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] 
 
Abbreviations / Units:  
SCr (standardized serum creatinine) = mg/dL 
ț   IHPDOHV RU  PDOHV 
Į  -0.329 (females) or -0.411 (males) 
PLQ  LQGLFDWHV WKH PLQLPXP RI 6&Uț RU  
PD[  LQGLFDWHV WKH PD[LPXP RI 6&Uț RU  
age = years 














Protocol TERN101-2001 
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Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
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Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
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Version: Amendment 1 
Version Date: 22 May 2020 
CONFIDENTIAL 
Page 74 of 82 
Appendix 8: Pruritus Numerical Rating Scale 
This Numerical Rating Scale was adapted from IFSI SIG/EADV Task Force Pruritus 
assessments available at http://www.pruritussymposium.de/numericalratingscale.html. 
 


Protocol TERN101-2001 
Terns, Inc. 
Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 75 of 82 
 
Appendix 9: COVID-19 Assessments 
At Screening:  
x SARS-CoV-2 testing to assess for active infection (e.g. molecular test such as polymerase 
chain reaction [PCR] or viral antigen serology) and past infection (Immunoglobulin G 
[IgG] antibody required; Immunoglobulin M [IgM] antibody recommended in addition).  
x Prior to central laboratory testing availability, antibody testing may be omitted if not 
available locally. 
At Week 0, 6, and 12:  
x Testing for past infection via antibody testing (IgG required; IgM recommended in 
addition) if prior IgG was negative.  
x Prior to central laboratory testing availability, testing for active infection (e.g. molecular 
test such as PCR or viral antigen serology) may replace antibody testing if the latter is not 
available locally. 
x If Week 0 occurs within 2 weeks of Screening, site may omit repeat SARS-CoV-2 testing 
at PI discretion. 
x If IgM antibody test is positive, may reflex to test for SARS-CoV-2 active infection at 
Investigator’s discretion 
Ad-hoc:  
x In the event of symptoms suggestive of COVID-19, ad hoc testing (including molecular 
test such as PCR or viral antigen serology, and/or antibody testing, once available via the 
central laboratory), may be completed at Investigator’s discretion. 
Sites may use local laboratory testing for COVID-19 assessments instead of central laboratory, 
per site preference. If a local laboratory is used, the results must be entered into the eCRF. 
Results from previous testing may be used if completed within 2 weeks of a scheduled Screening 
or on-study visit. 
Any positive tests reflecting active or recent infection (e.g. molecular test such as PCR or viral 
antigen serology, or IgM antibody) require management per local public health guidelines, at the 
direction of the investigator. 
If technological changes result in changes to the assays implemented to assess for SARS-CoV-2, 
available central lab assays and testing mechanisms may change. 
The testing approach and schedule may be modified based on the evolving landscape of the 
pandemic or in response to local public health requirements. In that event, regulatory 
requirements, IRB requirements, and local institutional guidelines will be followed, as necessary. 


Protocol TERN101-2001 
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Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 76 of 82 
 
Appendix 10: Abbreviations 
Abbreviation or 
Special Term 
Explanation 
7-Į-C4 
Į-hydroxy-4-cholesten-3-one 
ȕ-hCG 
Human chorionic gonadotropin 
ADaM 
Analysis Data Model 
ADL 
Activities of Daily Living 
AE 
Adverse event 
ALP 
Alkaline phosphatase 
ALT 
Alanine transaminase  
ANCOVA 
Analysis of covariance  
AST 
Aspartate transaminase 
AUC 
Area under the concentration-time curve 
BMI 
Body mass index 
BUN 
Biliary urea nitrogen 
CAP 
Controlled attenuation parameter 
CDISC 
Clinical Data Interchange Standards Consortium 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Sciences 
COVID-19 
Coronavirus disease 2019 
CPK 
Creatinine phosphokinase 
CONSORT 
Consolidated Standards of Reporting Trials 
Cmax 
Maximal concentration 
CRF 
CSR 
Case report form 
Clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
CYP 
Cytochrome P450 
CV 
Coefficient of variation 
DBL 
Database lock 
eGFR 
Estimated glomerular filtration rate 
eCRF 
Electronic case report form 
ECG 
Electrocardiographic 
ET 
Early Termination 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
FGF 
Fibroblast growth factor 
FSH 
Follicle stimulating hormone 


Protocol TERN101-2001 
Terns, Inc. 
Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 77 of 82 
 
Abbreviation or 
Special Term 
Explanation 
FXR 
Farnesoid X receptor 
GCP 
Good clinical practice 
GGT 
Gamma-glutamyl transpeptidase 
HBsAG 
Hepatitis B virus surface antigen 
HCV 
Hepatitis C virus 
HDL 
High-density lipoprotein 
HIV 
Human immunodeficiency virus 
HIPAA 
Health Insurance Portability and Accountability Act 
HRT 
Hormone replacement therapy 
ICF 
Informed consent form 
ICH 
International Council on Harmonisation 
IEC 
Independent Ethics Committee 
IND 
Investigational new drug 
INR 
International normalized ratio 
IRB 
Institutional Review Board 
IUD 
Intrauterine device 
IUS 
Intrauterine hormone-releasing system 
IWRS 
Interactive web response system 
LAM 
lactational amenorrhoea method 
LDL 
Low-density lipoprotein  
LDLR 
Low-density lipoprotein receptor  
LFC 
Liver fat content 
LFT 
Liver function test 
MCH 
Mean corpuscular hemoglobin 
MCV 
Mean corpuscular volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI-PDFF 
Magnetic Resonance Imaging Proton Density Fat Fraction  
mpk 
mg/kg 
NAFLD 
Non-alcoholic fatty liver disease 
NAS 
Non-alcoholic fatty liver disease activity score 
NASH 
Non-alcoholic Steatohepatitis 
NCI 
National Cancer Institute 
NHP 
Nonhuman primate 
NOAEL 
No observed adverse effect level 
OCA 
Obeticholic acid 
PCR 
Polymerase chain reaction 


Protocol TERN101-2001 
Terns, Inc. 
Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 78 of 82 
 
Abbreviation or 
Special Term 
Explanation 
PD 
Pharmacodynamics 
PK 
Pharmacokinetics 
po 
Per os (oral) 
QD 
Once daily 
RBC 
Red blood cell 
RNA 
Ribonucleic acid 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SARS-CoV-2 
Severe acute respiratory syndrome coronavirus 2 
SCr 
Standardized serum creatinine 
SD 
Sprague Dawley 
SoA 
Schedule of Activities 
SUSAR 
Suspected unexpected serious adverse reactions 
TEAE 
Treatment emergent adverse event 
TERN-101 
An investigational agonist of Farnesoid X receptor 
US 
United States 
VLDL 
Very low-density lipoprotein 
WBC 
White blood cell 
WOCBP 
Women of child bearing potential 
 
 
 


Protocol TERN101-2001 
Terns, Inc. 
Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 79 of 82 
 
Appendix 11: Investigator Signature Page 
Protocol Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 
Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of 
Orally Administered TERN-101 Tablets in Adult Patients with Presumed Non-Cirrhotic Non-
Alcoholic Steatohepatitis (NASH) 
Protocol Number:  
 
TERN101-2001 
Protocol Version/Date:  
Amendment 1; 22 May 2020 
 
I confirm that I have read the above-mentioned protocol and its attachments. I agree to conduct 
the described trial in compliance with all stipulations of the protocol, regulations and ICH E6 
Guideline for Good Clinical Practice (GCP). I will provide all study personnel under my 
supervision copies of the protocol and access to all information provided by Terns, Inc. I will 
discuss this material with them to ensure that they are fully informed about the study drug and 
the study. 
____________________________________ 
Principal Investigator Name (Printed)  
 
____________________________________ 
Signature  
 
____________________________________ 
Date 
 
 


Protocol TERN101-2001 
Terns, Inc. 
Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 80 of 82 
 
Appendix 12: Protocol Amendment History 
This document (dated 22 May 2020) is Amendment 1, the document history is below. The 
Summary of Changes for each amendment listed below will be provided separately. 
DOCUMENT HISTORY 
Document 
Date 
Amendment 1 
22-May-2020 
Original 
26-Feb-2020 


Protocol TERN101-2001 
Terns, Inc. 
Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 81 of 82 
 
Appendix 13: References 
Andronescu CI, Purcarea MR, Babes PA. Nonalcoholic fatty liver disease: epidemiology, 
pathogenesis and therapeutic implications. J Med Life. 2018;11(1):20–23. 
Cariou B and Staels B. FXR: A Promising Target for the Metabolic Syndrome? Trends in Pharm 
Sci. 2007;28:236-243. 
Chalasani N, Younossi Z,2 Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, 
and Sanyal AJ. The Diagnosis and Management of Nonalcoholic Fatty Liver Disease: Practice 
Guidance from the American Association for the Study of Liver Diseases. Hepatol. 2018;67:328-
57. 
Dietrich P, Hellerbrand C. Non-alchoholicalcoholic Fatty LiverLiver Disease, Obesity, and the 
Metabolic Syndrome. Best Pract and Res. 2014;28:637-53. 
Ekstedt M, Hagstrom H, Nasr P, Fredrikson M, Stal P, Kechagias S et al. Fibrosis Stage is the 
Strongest Predictor for Disease-specific Mortality in NAFLD After up to 33 years of Follow-up. 
Hepatology. 2015;61:1547-54. 
Enanta Pharmaceuticals. Press Release. 25 September 2019. 
Fiorucci S, Rizzo G, Donini A, Distrutti E and Santucci L. 2007. Targeting Farnesoid X Receptor 
for Liver and Metabolic Disorders. Trends in Mol Med. 2007;13:298-309. 
Harrison SA, Bashir MR, Shim-Lopen J, Son K, Chen HC. MET409, a susatained FXR agonist, 
decreased hepatic fat and improved liver function without raising LDL-C after 28 days in NASH 
patients. Paris NASH Meeting; July 2019; poster presentation. 
Houten SM, Watanabe M, and Auwerx J. Endocrine Functions of Bile Acids. EMBO J 
2006;25:1419–1425. 
Kalaany NY and Mangelsdorf DJ. LXRS and FXR: The Yin and Yang of Cholesterol and Fat 
Metabolism Annu. Rev Physiol. 2006;68:159–191. 
Lee FY, Lee H, Hubbert ML, Edwards PA and Zhang Y. FXR, a Multipurpose Nuclear Receptor. 
Trends Biochem Sci. 2006;31:572–580. 
Lonardo A, Nascimbeni F, Mantovani A, Targher G. Hypertension, diabetes, atherosclerosis and 
NASH: cause or consequence? J Hepatol. 2018;68:335-352. 
Makishima M, Okamoto AY, Repa JJ, Tu H, Learned RM, Luk A, Hull MV, Lustig KD, 
Mangelsdorf DJ and Shan B. Identification of a Nuclear Receptor for Bile Acids.  Science. 
1999;284:1362-1365. 


Protocol TERN101-2001 
Terns, Inc. 
Version: Amendment 1 
Version Date: 22 May 2020 
 
CONFIDENTIAL 
Page 82 of 82 
 
Mudaliar S, Henry RR, Sanyal AJ, Morrow L, Marscall H-U, Kipnes M, et al. Efficacy and 
Safety of the Farnesoid X Receptor Agonist Obeticholic Acid in Patients with Type 2 Diabetes 
and Nonalcoholic Fatty Liver Disease. Gastroenterology. 2013;145:574-582. 
National Heart, Lung, and Blood Institute. The Practical Guide: Identification, Evaluation, and 
Treatment of Overweight and Obesity in Adults. US Department of Health and Human Services, 
Public Health Service, National Institutes of Health, National Heart Lung and Blood Institute, 
Bethesda, MD, October 2000. Accessed on 29 January 220 at 
https://www.nhlbi.nih.gov/files/docs/guidelines/prctgd_c.pdf. 
Neuschwander-Tetri, B. A., Loomba, R., Sanyal, A. J., Lavine, J. E., Van Natta, M. L., 
Abdelmalek, M. F., et al. Farnesoid X Nuclear Receptor Ligand Obeticholic Acid for Non-
cirrhotic, Non-alcoholic steatohepatitis (FLINT): a Multicentre, Randomised, Placebo-controlled 
Trial. Lancet. 2015;385,956–965. 
Parks DJ, Blanchard SG, Bledsoe RK, Chandra G, Consler TG, Kliewer SA, Stimmel JB, Willson 
TM, Zavacki AM, Moore DD and Lehmann JM. Bile Acids: Natural Ligands for an Orphan 
Nuclear Receptor. Science. 1999;284:1365-1368. 
Rader DJ.  Liver X Receptor and Farnesoid X Receptor as Therapeutic Targets. Am J Cardiol. 
2007;100[Suppl]:15N–19N. 
Sanyal A, Lopez P, Lawitz E, Kim W, Huang JF, Andreone P, et al. Tropifexor (TXR), an FXR 
agonist for the treatment of NASH - interim results from first two parts of Phase 2b Study 
FLIGHT-FXR. American Association for the Study of Liver Diseases Annual Meeting; San 
Francisco, CA; November 2018; Abstract 168. 
Wang K and Wan YJ. Nuclear Receptors and Inflammatory Diseases. Exp Biol Med. 
2008;233:496–506. 
Wang H, Chen J, Hollister K, Sowers LC, and Forman BM. Endogenous Bile Acids Are Ligands 
for the Nuclear Receptor FXR/BAR. Mol Cell. 1999;3:543-553. 
Wong RJ, Aguilar M, Cheung R, Perumpail RB, Harrison SA, Younossi ZM, Ahmed A. 
Nonalcoholic steatohepatitis is the second leading etiology of liver disease among adults awaiting 
liver transplantation in the United States. Gastroenterol. 2015;148: 547-55. 
Younossi ZM, Raziu V, Loomba R, Rinella M, Anstee QM, Goodman Z et al. Obeticholic acid for 
the treatment of non-alcoholic steatohepatitis: interim analysis from a multicenter, randomized, 
placebo-controlled phase 3 trial. Lancet. 2019;394:2184-96. 
Zhang Y and Edwards PA. FXR Signaling in Metabolic Disease. FEBS Lett. 2008;582:10-18. 
 

SAP_001.pdf: 
Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
Statistical Analysis Plan                                                                                                                           CONFIDENTIAL 
Page 1 of 58 
 
Statistical Analysis Plan 
Protocol Title:  
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 
Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, 
Tolerability, Efficacy, and Pharmacokinetics of Orally Administered 
TERN-101 Tablets in Adult Patients with Presumed Non-Cirrhotic 
Non-Alcoholic Steatohepatitis (NASH) 
Compound:  
TERN-101 
US IND Number:   
 
ClinicalTrials.gov 
Identifier: 
NCT04328077 
Protocol Version and 
Date: 
Amendment 1, 22 May 2020 
Phase: 
2a 
Methodology: 
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 
Sponsor: 
Terns, Inc. 
1065 E. Hillsdale Blvd. Suite 100 
Foster City, California 94404 
Analysis Plan Date: 
19 May 2021 
Analysis Plan 
Version: 
Final  
CONFIDENTIAL 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Terns, Inc. 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
Statistical Analysis Plan                                                                                                                           CONFIDENTIAL 
 
Page 2 of 58 
 
TABLE OF CONTENTS 
1. 
Introduction ........................................................................................................... 8 
2. 
Information from the Study Protocol .................................................................... 8 
2.1. 
Study Objectives .............................................................................................................. 8 
2.2. 
Study Design .................................................................................................................... 8 
2.2.1. 
Study Procedures .................................................................................... 9 
2.2.2. 
Study Population ..................................................................................... 9 
2.2.3. 
Study Drug .............................................................................................. 9 
2.2.4. 
Treatment Assignment, Blinding, and Randomization Methodology .. 10 
2.3. 
Study Endpoints ............................................................................................................. 11 
2.3.1. 
Primary Endpoints ................................................................................ 11 
2.3.2. 
Secondary Endpoints ............................................................................ 11 
2.3.3. 
Exploratory Endpoints .......................................................................... 11 
3. 
Sample Size Justification .................................................................................... 12 
4. 
General Statistical Methods ................................................................................ 12 
4.1. 
Reporting Conventions ................................................................................................... 12 
4.2. 
Computing Environments .............................................................................................. 14 
4.3. 
Partial Dates ................................................................................................................... 14 
4.4. 
Data Conventions ........................................................................................................... 14 
4.5. 
Standard Calculations ..................................................................................................... 14 
4.6. 
Treatments ...................................................................................................................... 15 
4.7. 
Visits............................................................................................................................... 16 
4.7.1. 
Windows ..................................................................................................................... 16 
4.7.2. 
Definition of Baselines ............................................................................................... 16 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
Statistical Analysis Plan                                                                                                                           CONFIDENTIAL 
 
Page 3 of 58 
 
4.7.3. 
Definition of End of Treatment .................................................................................. 17 
5. 
Analysis Sets ....................................................................................................... 17 
6. 
Examination of Subgroups .................................................................................. 18 
7. 
Study Population ................................................................................................. 18 
7.1. 
Patient Disposition ......................................................................................................... 18 
7.2. 
Demographics and Baseline Characteristics .................................................................. 19 
7.3. 
Protocol Deviations ........................................................................................................ 21 
7.4. 
General Medical History ................................................................................................ 22 
7.5. 
Prior and Concomitant Medications ............................................................................... 22 
8. 
Efficacy Analyses ............................................................................................... 22 
8.1. 
Adjustments for Covariates ............................................................................................ 22 
8.2. 
Handling of Dropouts or Missing Data .......................................................................... 23 
8.3. 
Interim Analyses and Data Monitoring .......................................................................... 23 
8.4. 
Multicenter Studies ........................................................................................................ 23 
8.5. 
Use of an “Efficacy Subset” of Patients ......................................................................... 23 
8.6. 
Multiple Comparisons/Multiplicity ................................................................................ 23 
8.7. 
Secondary Efficacy Analyses: Percent Change from Baseline in ALT Levels at Week 
12 
23 
8.7.1. 
Additional Exploratory Analyses of ALT ............................................. 24 
8.7.1.1. 
Change from Baseline in ALT ......................................................................... 24 
8.7.1.2. 
Change from End of Treatment in ALT .......................................................... 25 
8.7.1.3. 
ALT Responder Analyses ................................................................................ 25 
8.8. 
Exploratory Efficacy Analyses....................................................................................... 26 
8.8.1. 
Magnetic Resonance Imaging ............................................................... 26 
8.8.1.1. 
Liver Fat Content by MRI Proton Density Fat Fraction (PDFF) .................... 26 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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8.8.1.2. 
cTI .................................................................................................................... 27 
8.8.2. 
Liver Function Tests ............................................................................. 27 
8.8.3. 
NASH and Fibrosis Biomarkers ........................................................... 28 
8.8.3.1. 
Fibrosis-4 (FIB-4) Score .................................................................................. 28 
8.8.3.2. 
Enhanced Liver Fibrosis (ELF) Score ............................................................. 28 
8.8.3.3. 
Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score .......................... 29 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.10. 
Pharmacodynamic (PD) Analyses .............................................................................. 34 
8.10.1. 
Below the Quantification Level (BLQ) Values................................. 34 
8.10.2. 
Concentration-Time Data .................................................................. 34 
8.10.3. 
Change from Baseline ....................................................................... 35 
 
 
 
 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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9. 
Safety Analyses ................................................................................................... 38 
 
 
9.2. 
Adverse Events ............................................................................................................... 39 
9.2.1. 
Overall Summary of Adverse Events ................................................... 39 
9.2.2. 
Patient Incidence of Adverse Events .................................................... 40 
9.2.3. 
Pruritus .................................................................................................. 41 
9.3. 
Clinical Safety Laboratory Evaluations ......................................................................... 41 
9.3.1. 
Treatment Emergent Abnormalities ...................................................... 42 
9.3.2. 
Special Assessments of Potential Hepatotoxicity ................................. 42 
9.3.3. 
Fasting Glucose and Lipids ................................................................... 45 
9.3.4. 
Shifts in CTCAE Grade ........................................................................ 45 
9.3.5. 
Shifts in Normal Range ......................................................................... 46 
9.3.6. 
COVID-19............................................................................................. 47 
 
 
 
 
 
 
 
13. Appendices .......................................................................................................... 50 
 
 
Appendix 2. 
Other General Programming Specifications ..................................... 52 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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Appendix 3. 
Imputation Rules for Missing or Partial Dates for Adverse Events and 
Concomitant Medications ........................................................................................... 54 
Appendix 4. 
Abbreviations .................................................................................... 55 
Appendix 5. 
Document History ............................................................................. 57 
Appendix 6. 
Approval Page ................................................................................... 58 
 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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LIST OF TABLES 
Table 1: 
Study Drug .......................................................................................................10 
Table 2: 
Study Administration by Dose Group..............................................................10 
Table 3: 
Power and Sample Size Determination............................................................12 
Table 4: 
Treatment Group Labels and Ordering ............................................................15 
Table 5: 
Treatment Period Visit Windows.....................................................................16 
Table 6: 
Analysis Sets ....................................................................................................17 
Table 7: 
Plasma Pharmacokinetic Parameters ...............................................................32 
 
 
Table 9: 
Modified Hy’s Rule Laboratory Abnormalities ...............................................43 
 
 
Table 11: 
CTCAE Laboratory Tests with Clinical Criteria .............................................45 
 
LIST OF FIGURES 
Figure 1: 
Overall Study Design .........................................................................................9 
 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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1. 
INTRODUCTION 
This statistical analysis plan (SAP) document outlines the statistical methods to be implemented 
during the analyses of Study Protocol TERN101-2001.  The purpose of this plan is to provide 
specific guidelines from which the analyses will proceed.  Any deviations from these guidelines 
will be documented in the clinical study report (CSR).    
This SAP supersedes the statistical considerations identified in the protocol; where 
considerations are substantially different, they are identified in Section 11. Any post-hoc or 
unplanned analyses, or significant changes from the planned analysis in this SAP performed to 
provide results for inclusion in the CSR but not included in this SAP, will be clearly identified in 
the CSR. Changes to planned analyses do not require an updated SAP but will be included in the 
CSR if significant. 
2. 
INFORMATION FROM THE STUDY PROTOCOL 
2.1. 
Study Objectives 
Primary Objective: 
x To evaluate safety and tolerability of 3 doses of orally administered TERN-101 
versus placebo for 12 weeks in non-cirrhotic presumed NASH patients, with clinical 
or histological NASH diagnosis 
Secondary Objectives: 
x To evaluate the change in alanine aminotransferase (ALT) with 3 doses of TERN-101 
for 12 weeks versus placebo in non-cirrhotic presumed NASH patients 
x To evaluate the pharmacokinetics (PK) of 3 doses of TERN-101 in non-cirrhotic 
presumed NASH patients 
Exploratory Objectives: 
x To assess the effect of 3 doses of TERN-101 on liver fat content (LFC) and additional 
indicators of NASH disease activity 
x To evaluate farnesoid X receptor (FXR) target engagement of 3 doses of TERN-101 
in non-cirrhotic presumed NASH patients 
x To evaluate the effect of 3 doses of TERN-101 on biomarkers of liver fibrosis 
2.2. 
Study Design 
This study is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to 
evaluate the safety, tolerability, efficacy, and PK of various doses of TERN-101 in non-cirrhotic 
presumed non-alcoholic steatohepatitis (NASH) patients. TERN-101 is a highly selective and 
potent small molecule agonist of farnesoid X receptor (FXR) in development for the treatment of 
patients with NASH, a serious and advanced form of non-alcoholic fatty liver disease (NALFD). 
The study aims to characterize the effects of varying doses of TERN-101 in a NAFLD patient 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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population with presumed NASH. Currently, there are no approved therapies for the treatment of 
NASH. 
Figure 1 describes the overall study design. The total study duration will be approximately 24 
weeks, consisting of an 8-week Screening Period, a 12-week Treatment Period and a 4-week 
Follow-up Period. 
Figure 1: 
Overall Study Design 
 
Abbreviations: MRI-PDFF = magnetic resonance imaging proton density fat fraction; PK/PD = 
pharmacokinetics/pharmacodynamics; QD = once a day 
Of the approximately 96 patients randomized, 24 patients will take part in an intensive PK and 
pharmacodynamic (PD) collection after the first dose and after the last dose of study drug. This 
includes 6 patients at each TERN-101 dose level, and 6 patients in the placebo group. Patients 
who are not participating in the PK/PD sub-study will have trough PK/PD sampling only.  
2.2.1.
Study Procedures 
The overall schedule of activities is outlined in Section 1.3 of the study protocol.  See study 
protocol for complete details. 
2.2.2.
Study Population 
This study includes non-cirrhotic presumed NASH patients.  Inclusion and exclusion criteria are 
provided in Sections 5.1 and 5.2, respectively, of the study protocol. 
2.2.3.
Study Drug
Study drug is defined as any investigational intervention(s), marketed product(s), or placebo 
intended to be administered to a study patient according to the study protocol. 










Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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Other general programming specifications are provided in Appendix 1. 
4.2. 
Computing Environments 
All descriptive statistical analyses will be performed using SAS software Version 9.4 or higher, 
unless otherwise noted.  
Plasma PK 
 for TERN-101 will be estimated using non-compartmental 
methods with Phoenix WinNonlin® Version 8.3 or higher. 
Medical history and AEs will be coded using Medical Dictionary for Regulatory Activities 
(MedDRA) version 23.0. Concomitant medications will be coded using World Health 
Organization Drug Dictionary (WHODD), B2 Enhanced March 2020. 
Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets will be 
prepared using Clinical Data Interchange Standards Consortium (CDISC) SDTM 
Implementation Guide (IG) Version 3.3, ADaM Version 2.1, and CDISC ADaM IG Version 1.2 
including most current occurrence and time to event IGs. 
4.3. 
Partial Dates  
Imputation of partial adverse event and concomitant medication dates are specified in 
Appendix 2, respectively. 
All data recorded on the case report form will be included in data listings. 
4.4. 
Data Conventions 
The precision of original measurements will be maintained in summaries, when possible. 
Quantitative safety laboratory tests containing less than (<) and greater than (>) symbols are test 
results that are below and above quantifiable limits, respectively. In order to retain these values 
for analysis purpose, the following will be imputed and stored within the analysis datasets: 
x For values with <, the imputed value will be the numeric portion × 0.9. 
x For values with >, the imputed value will be the numeric portion × 1.1. 
PK and PD imputation of values below the limitation of quantitation (BLQ) are specified in 
Section 8.9.1 and Section 8.10.1, respectively. 
Variables with a non-normal distribution that impacts the interpretation or validity of the planned 
analysis may have a data transformation applied (e.g., ln, log10).  
4.5. 
Standard Calculations 
Variables requiring calculation will be derived using the following formulas: 
x Days – A duration expressed in days between one date (date1) and another later date 
(date2) will be calculated using the following formulas:   
duration in days = date2 – GDWH   ZKHUH GDWH ILUVW DGPLQLVWUDWLRQ GDWH 
duration in days = date2 – date1, where date1 <first administration date 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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x Months – A duration expressed in months is calculated as the number of days divided by 
30.4375 
x Years – A duration expressed in years between one date (date1) and another date (date2) 
is calculated using the following formulas: 
duration in years = (date2 – GDWH   ZKHUH GDWH ILUVW DGPLQLVWUDWLRQ
date 
duration in years = (date2 – date1)/365.25, where date1<first administration date 
x Body Mass Index (BMI) – BMI is calculated using height (cm) and weight (kg) using the 
following formula: 
BMI (kg/m2) = weight (kg) / ([height (cm)/100]2) 
x Change (CHG; equivalent to absolute change for liver fat content [LFC]) – Change will 
be calculated as: 
Change = later value – earlier (i.e. baseline) value 
x Percent change (PCHG; equivalent to relative change for LFC) – Percent change will be 
calculated as: 
Percent change = ([Change] / earlier [i.e. baseline] value) × 100 
4.6. 
Treatments  
Table 4 presents how the dose groups will be presented on TFLs as treatment groups, including 
the order.   
Table 4: 
Treatment Group Labels and Ordering 
Treatment Group Label 
Order 
on TFLs 
Placebo  
1 
5 mg 
2 
10 mg 
3 
15 mg 
4 
All TERN-101  
5 
Overall (where specified) 
6 
Screen failures will be presented on by-patient listings where data is available.   


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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4.7. 
Visits 
4.7.1. 
Windows   
Each visit will be denoted by its visit “Week”. The first dose day is denoted as Day 1. In data 
listings, the relative study day of all dates from first dose will be presented. 
In the event of unscheduled visits or early treatment termination (ET) assessments, these will be 
reassigned to a scheduled visit for analysis purposes according to Table 5 for on treatment 
assessments. If multiple assessments occur within a single visit window, after reassignment of 
unscheduled visits and ET assessments, the assessment closest to the target day of the visit 
window will be used in the analysis. If there is a tie, the later assessment will be used in the 
analysis.   
Table 5: 
Treatment Period Visit Windows 
Target Scheduled Visit 
Target 
Study 
Day a 
Analysis Window Study Day a 
Low 
High 
Baselineb 
1 
See Section 4.7.2 
Week 2 
15 
2 
22 
Week 4 
29 
23 
36 
Week 6 
43 
37 
50 
Week 8 
57 
51 
71 
Week 12c 
85 
72 
92c 
a Study day will be calculated from first dose of study drug.  
b Baseline is defined in Section 4.7.2. 
c LFC and cTI by MRI will have no upper limit on Week 12. 
The follow up visit (Week 16) will not be windowed.  As described in Section 8.7.1, sensitivity 
analyses will be conducted including only Week 16 assessments which are at least 22 days from 
last dose. 
4.7.2. 
Definition of Baselines 
The baseline value for statistical analyses of quantitative laboratory parameters is defined as the 
mean of all available evaluations, including any unscheduled or repeat assessments, prior to the 
first administration of study drug, unless otherwise specified.  If there is only one evaluation 
prior to the first administration of study drug, then the available data from this evaluation will be 
used as the baseline value.  
For glucose and lipid parameters, only assessments taken while fasting for 8 hours will be 
included in the baseline derivation. 
The baseline value for analyses of qualitative parameters (e.g., normal/abnormal) is defined as 
the last evaluation prior to the first administration of study drug. 
The baseline value for analyses of weight, body mass index (BMI), and electrocardiogram 
parameters is defined as the last evaluation prior to the first administration of study drug. 






Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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x Number in each analysis set. The denominator for percentage in each analysis set will be 
the number of randomized patients. In addition, the number of patients randomized to the 
PK/PD substudy will be presented. 
x Number who discontinued treatment early and reason(s) for discontinuation of treatment. 
The denominator for percentages will be the number of randomized and treated patients 
(Efficacy Analysis Set). 
x Number who discontinued from study prior to completing the study and reason(s) for 
discontinuation. The denominator for percentages will be the number of randomized and 
treated patients (Efficacy Analysis Set). 
A by-patient data listing of study disposition information including the reasons for treatment 
and/or study termination will be presented.  Withdrawal of consent details will also be included, 
if applicable. 
A by-patient data listing including the reasons for exclusion from each analysis set will be 
presented. 
7.2. 
Demographics and Baseline Characteristics 
Demographic variables will include the following: 
x Age at informed consent including the subgroup RI  \HDUV YV  \HDUV 
x Sex 
x Race 
x Ethnicity 
Other baseline characteristics will include the following: 
x Weight (kg) 
x Height (cm) 
x BMI (kg/m2) including the following subgroup:   -   - <40  NJP2 
x Waist circumference (cm) 
x Baseline liver stiffness by transient elastography (kPa) 
x Baseline Controlled Attenuation Parameter (CAP; dB/m) 
x %DVHOLQH /)&  E\ 05,-PDFF 
x Baseline cTI (msec) by MRI including the following subgroup: Low (<800 msec), 
Elevated (800 – 875 msec), and High (>875 msec). 
x Liver Biopsy within 2 years of randomization 
o Baseline fibrosis stage (F1, F2, F3) 
o Baseline NAFLD Activity Score (NAS) 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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x Baseline Comorbidities will be based on Medical History case report form, Medical 
Dictionary of Regulatory Activities (MedDRA) preferred term (PT) 
o Diabetes status (yes, no) will be defined as PT preferred term (PT) includes “diabetes 
mellitus” or “Diabetic neuropathy” will be assigned yes, otherwise no. 
o Hypertension (yes, no) will be defined as PT of “Hypertension” will be assigned yes, 
otherwise no. 
o Dyslipidemia (yes, no) will be defined as Standardized MedDRA query (SMQ) of 
“Dyslipidemia (SMQ)” will be assigned yes, otherwise no. 
x Baseline medication use, defined as starting prior to first administration of study drug, 
regardless of end date:  
o Statins defined by the WHODD Standardized Drug Grouping (SDG) of “Statins” 
o Antihypertension medications defined by the WHODD SDG of “Antihypertensives” 
o Antithrombotic medications defined by WHODD SDG of “Antithrombotic drugs” 
o Antidiabetic medications defined by the WHODD SDG of “Drugs used in diabetes” 
o NASH Medications, defined as the following medications with potential beneficial 
effect on NASH: 
í Vitamin E defined by the WHODD drug codes beginning in “001105” or if 
“VITAMIN E” is found in the preferred drug name  
í Obeticholic acid defined by WHODD drug codes of 064968 01 001 through 
064968 01 003  
í Pioglitazone RU RWKHU 33$5Ȗ DJRQLVWV defined by WHODD ATC level 4 
A10BD and A10BG 
í GLP-1 analogues defined by WHODD ATC level 4 code (term) A10BJ 
(Glucagon-like peptide-1 [GLP-1] analogues) 
í DPP-4 inhibitors defined by WHODD ATC level 4 code (term) A10BH 
(Dipeptidyl peptidase 4 [DPP-4] inhibitors) 
í SGLT2 inhibitors defined by WHODD ATC level 4 code (term) A10BK 
(Sodium-glucose co-transporter 2 [SGLT2] inhibitors) 
o Steatohepatitis Medications, defined as the following medications that may 
potentially worsen steatohepatitis: 
í Corticosteroids (of > 10 mg/day for > 2 weeks [prednisone or prednisone 
equivalent dose (Appendix 1)]) defined by WHODD ATC level 2 code (term) 
H02 (Corticosteroids for Systemic Use) 
í Amiodarone defined by WHODD drug codes 001331 01 001 through 001331 
01 029 and 001331 02 001 through 001331 02 250   
í Tamoxifen defined by WHODD drug codes of 003887 01 001 through 
003887 01 020 and 003887 02 001 through 003887 02 273  










































Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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x Adverse events leading to study drug interruption (subset of the AEs where Action 
Taken with Study Drug is checked as “Study drug interrupted”). 
x Adverse events leading to study drug discontinued (subset of the AEs where Action 
Taken with Study Drug is checked as “Study drug discontinued”). 
x Adverse events leading to death (subset of the AEs where outcome is indicated as 
“Fatal” or the CTCAE grade is 5 or seriousness criteria is Death). 
9.2.3. 
Pruritus 
For patients who report AEs consistent with pruritus at the visit, a qualified staff member will 
administer the Pruritus Numerical Rating Scale (see Appendix 8 of the study protocol). The 
Pruritus Numerical Rating Scale assesses a patient’s severity of itching on average and at its 
worst point, in the past 24 hours, on a scale of 0 (no itching) to 10 (worst imaginable itch). 
Treatment-emergent pruritus is defined as any preferred term including “Prur”.  Pruritus will be 
summarized overall with  
An overall summary of pruritus will be presented by treatment group.  The number and 
percentage of patients who experience at least one of the following: 
x Any Pruritus TEAE, All CTCAE grades 
x Pruritus TEAEs by Maximum Severity (Grade 1, 2, or 3) 
x Serious Pruritus TEAE 
x Treatment-related Pruritus TEAE, All CTCAE grades 
x Treatment-related Grade 3 or higher Pruritus TEAE 
x Treatment-related serious Pruritus TEAE 
x Pruritus TEAE leading to study drug interruption 
x Pruritus TEAE leading to study drug discontinued 
x Pruritus TEAE leading to discontinuation from the study 
    
A separate by-patient listing for pruritus events will be provided with associated Pruritus 
Numerical Rating Scale results, if applicable. 
9.3. 
Clinical Safety Laboratory Evaluations 
All laboratory assessments are specified in Appendix 1 of the study protocol. Laboratory 
parameters will be summarized in conventional units. Coagulation parameters, hemoglobin A1c, 
direct bilirubin, and indirect bilirubin will not be summarized. 
Quantitative serum chemistry and hematology results will be summarized by treatment group 
using descriptive statistics at baseline and at each post-baseline visit.  The change and percent 
change from baseline will also be summarized.   


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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All clinical safety laboratory data will be presented in by-patient data listings. A separate listing 
for central laboratory normal ranges, by lab category, lab test, lab parameter, sex, and age, will 
be presented. Any local laboratory normal ranges for COVID-19 will be presented separately. 
9.3.1. 
Treatment Emergent Abnormalities 
Quantitative laboratory tests will be assigned grades based on National Cancer Institute Common 
Terminology Criteria for Adverse Events (NCI CTCAE) Version 5. For each applicable 
laboratory test, a treatment emergent abnormality will be defined as a post-baseline through 
Week 16 &7&$( JUDGH LQFUHDVH RI  JUDGHV 
The number and percentage of patients overall and by laboratory test, with any treatment 
emergent laboratory abnormality, CTCAE increase RI  JUDGHV, will be presented. Similarly, the 
number and SHUFHQWDJH RI SDWLHQWV RYHUDOO DQG E\ ODERUDWRU\ WHVW ZLWK &7&$( LQFUHDVH RI 1 
grade will be presented.   
Estimated glomerular filtration rate (eGFR) is calculated by the central lab using the Chronic 
Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.  eGFR does not have a 
normal range within the central lab data.  A normal range will be defined as 90 mL/min/1.73m2. 
LDL-c cannot be graded via NCI CTCAE version 5.  For the purposes of treatment emergent 
abnormalities, LDL will be graded as follows: 
x Optimal: < 100 mg/dL 
x Near or Above Optimal: 100 – 129 mg/dL 
x Borderline High: 130 – 159 mg/dL 
x High: 160 – 189 mg/dL 
x Very High: >189 mg/dL 
LDL-c treatment emergent abnormalities will be summarized separately. 
Listings will be presented for any patient with any treatment emergent laboratory abnormality 
(any increase in CTCAE grade). Normal ranges provided by the central laboratory will be 
presented in a listing. 
9.3.2. 
Special Assessments of Potential Hepatotoxicity  
Number and percentage of patients meeting each of the below criteria in Table 9 will be 
summarized by treatment group. 
Modified Hy’s rule by Bjornsson (Bjornsson 2005), the incidence of patients with ALT or AST 
values >3x ULN and total bilirubin >2x ULN (based on the same blood draw of ALT, AST, and 
total bilirubin while on study drug, or within 30 days of last received dose) will be used to assess 
the potential for study drug-induced liver toxicity. The incidence rates of this laboratory 
abnormality constellation will be presented. Any patient meeting any of the criteria specified in 
Table 9 will be presented.   














Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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12. 
REFERENCES 
Björnsson. Drug-induced liver injury: Hy’s rule revisited. Clinical Pharmacology Therapeutics. 
2006;79(6):521-8. 
Bornkamp, et. al., MCPMod: An R Package for the Design and Analysis of Dose-Finding 
Studies, Journal of Statistical Software, February 2009, Volume 29, Issue 7. 
Guidance for Industry E3: Statistical Principles for Clinical Trials. U.S. Department of Health 
and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 
(CDER), Center for Biologics Evaluation and Research (CBER), September 1998. 
Guidance for Industry E9: Statistical Principles for Clinical Trials. U.S. Department of Health 
and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 
(CDER), Center for Biologics Evaluation and Research (CBER), September 1998. 
Guidance for Industry E14: The Clinical Evaluation of QT/QTc Interval Prolongation and 
Proarrhythmic Potential for Non-antiarrhythmic Drugs. U.S. Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 
October 2005. 
Guidance for Industry: Drug Induced Liver Injury: Premarketing Clinical Evaluation, CDER, 
FDA (2009). 
Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Certain 
Human Pharmaceutical Product Applications and Related Submissions Using the eCTD 
Specifications, Center for Drug Evaluation and Research (CDER), Center for Biologics 
Evaluation and Research (CBER), September 2016. 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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13. 
APPENDICES 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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APPENDIX 3. IMPUTATION RULES FOR MISSING OR PARTIAL 
DATES FOR ADVERSE EVENTS AND CONCOMITANT 
MEDICATIONS  
Date 
Situation 
Imputation Rule 
Start Date 
Only month and year are known and month 
and year are prior to first dose date  
Use the last day of the month 
Only month and year are known and month 
and year are the same as first dose date 
Use the first study drug 
administration date 
Only month and year are known and month 
and year are after first dose date 
Use the first day of the 
month 
Only year is known and year is before first 
dose date 
Use Dec 31 of that year 
 
Only year is known and year is same as first 
dose date 
Use the first study drug 
administration date 
Only year is known and year is after first 
dose date 
Use Jan 1 of that year 
Entire date is missing 
Use the first study drug 
administration date 
The estimated start date is after a complete 
or imputed AE stop date 
Use the first day of the 
month of the AE stop date 
Stop/End Date 
Only month and year are known and month 
and year are prior to last dose date  
Use the last day of the month 
Only month and year are known and month 
and year are the same as last dose date 
Use the last dose date 
Only month and year are known and month 
and year are after last dose date 
Use the last day of the month 
Only year is known and year is before last 
dose date 
Use Dec 31 of that year 
Only year is known and year is same as last 
dose date 
Use the last study drug 
administration date 
Only year is known and year is after last 
dose date 
Use Dec 31 of that year 
Entire date is missing 
Use the last study drug 
administration date 
The estimated stop date is before a complete 
or imputed AE start date 
Use the last day of the month 
of the AE start date 
AE = adverse event, Dec = December, Jan = January 
 
 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
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APPENDIX 4. ABBREVIATIONS 
Abbreviation or 
Special Term 
Explanation 
Į& 
Į-hydroxy-4-cholesten-3-one 
ADaM 
Analysis Data Model 
AE 
adverse event 
ALP 
alkaline phosphatase 
ALT 
alanine transaminase  
ANCOVA 
analysis of covariance  
AST 
aspartate transaminase 
ATC 
Anatomical Therapeutic Class 
AUC 
area under the concentration-time curve 
BLQ 
below limit of quantification 
BMI 
body mass index 
CAP 
Controlled Attenuation Parameter 
CDISC 
Clinical Data Interchange Standards Consortium 
CHG 
change from baseline ADaM basic dataset structure defined variable 
CI 
confidence interval 
CK-18 
cytokeratin-18 
COVID-19 
Coronavirus disease 2019 
Cmax 
maximal concentration 
CRF 
case report form 
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTMS 
clinical trial management system 
CV 
coefficient of variation 
DPP-4 
Dipeptidyl peptidase 4 
eGFR 
estimated glomerular filtration rate 
eCRF 
electronic case report form 
ECG 
electrocardiogram 
ET 
early termination 
FDA 
Food and Drug Administration 
FGF 
fibroblast growth factor 
FIB-4 
Fibrosis-4 Score 
FSH 
follicle stimulating hormone 
FXR 
farnesoid X receptor 
GGT 
gamma-glutamyl transpeptidase 
GLP-1 
Glucagon-like peptide-1 
HA 
hyaluronic acid 
HDL 
high-density lipoprotein 
hs-CRP 
high sensitivity C-reactive protein 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 


Terns, Inc.                                                                                                                                                                     Final 
Study No: TERN101-2001                                                                                                                              19 May 2021    
Statistical Analysis Plan                                                                                                                           CONFIDENTIAL 
 
Page 56 of 58 
 
Abbreviation or 
Special Term 
Explanation 
IG 
implementation guide 
IMP 
investigational medicinal product 
INR 
international normalized ratio 
IWRS 
interactive web response system 
LDL 
low-density lipoprotein  
LFC 
liver fat content 
LFT 
liver function test 
LLN 
lower limit of normal 
ln 
natural log 
LS 
least squares 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMRM 
mixed model for repeated measures 
MRI-PDFF 
Magnetic Resonance Imaging Proton Density Fat Fraction  
NAFLD 
non-alcoholic fatty liver disease 
NAS 
non-alcoholic fatty liver disease activity score 
NASH 
non-alcoholic steatohepatitis 
NC 
not calculated 
NCA 
noncompartmental analysis  
NCI 
National Cancer Institute 
PCHG 
percent change from baseline ADaM basic dataset structure defined variable 
PIIINP 
procollagen III n-terminal propeptide 
PD 
pharmacodynamics 
PK 
pharmacokinetics 
Pro-C3 
pro-peptide of type III collagen 
Q1 
25th percentile, first quartile 
Q3 
75th percentile, third quartile 
REML 
restricted maximum likelihood 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SD 
standard deviation 
SDG 
Standardized Drug Grouping 
SDTM 
Study Data Tabulation Model 
SE 
least squares mean standard error 
SGLT-2 
Sodium-glucose co-transporter 2 
TEAE 
treatment emergent adverse event 
TERN-101 
investigational agonist of Farnesoid X receptor 
TIMP-1 
tissue inhibitor of metalloproteinases-1 
ULN 
upper limit of normal 
WHODD 
World Health Organization Drug Dictionary