Conditions: Hyperlipidemia and Mixed Dyslipidemia
Keywords: High cholesterol Raised cholesterol Cholesterol Elevated Cholesterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3681
Healthy volunteers: no

Brief summary:
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

Detailed description:

Arms:
arm 1: Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \[all-IP\] period. arm 2: Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.

Interventions: intervention 1: Evolocumab intervention 2: Standard of Care
Intervention descriptions: intervention 1: Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen intervention 2: Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Protocol document:
Prot_000.pdf: 
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Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 3 of 65 
CONFIDENTIAL 
 
Protocol Synopsis 
Title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term 
Safety and Efficacy of AMG 145 
Study Phase: 3 
Indication:  Primary hyperlipidemia and mixed dyslipidemia 
Primary Objective:  To characterize the safety and tolerability of long-term administration of 
AMG 145. 
Secondary Objectives:  
To characterize efficacy of long-term administration of AMG 145 as assessed by low density 
lipoprotein cholesterol (LDL-C) in subjects with primary hyperlipidemia and subjects with mixed 
dyslipidemia. 
Hypotheses:  The primary clinical hypothesis is that long-term exposure of AMG 145 will be safe 
and well-tolerated in subjects with primary hyperlipidemia and subjects with mixed dyslipidemia. 
Primary Endpoint:  Subject incidence of adverse events.  
Secondary Endpoints: 
 
Percent change from baseline in LDL-C at Week 48 and Week 104 
 
Change from baseline in LDL-C at Week 48 and Week 104 
Study Design:  This is a multicenter, randomized, controlled, open-label extension study 
designed to assess the long-term safety and efficacy of AMG 145.  Subjects that successfully 
complete a qualifying protocol and sign informed consent will be randomized 2:1 to one of two 
groups: AMG 145 + standard of care (SOC) or SOC-alone. Subjects randomized to the treatment 
group will also be expected to take background lipid lowering therapy and will be able to choose 
from one of two dose regimens:  AMG 145 (140mg) administered every 2 weeks (Q2W) + SOC, 
or AMG 145 (420mg) administered monthly (QM) + SOC.  Subjects randomized to the control 
group will receive SOC alone for the first 48 weeks of the study. During the first 12 weeks of the 
study participation, LDL-C will remain blinded and subjects must remain on stable background 
lipid lowering therapy.  Using clinical judgment, the primary investigator or qualified delegate 
should recommend background lipid lowering therapy the subject can be expected to tolerate: 
therapy either prescribed to them PRIOR to participation in parent study, or statin or ezetimibe 
therapy given during parent study.  Investigators will be informed if triglycerides are > 1000 mg/dL 
(11.3 mmol/L) so that appropriate subject follow-up can be initiated if necessary (see Protocol 
Section 6.1.3.4).  Randomization should occur within 30 days after the parent study’s EOS visit. 
Subjects will be stratified by their parent study and frequency of SC dose (Q2W or QM) within the 
parent study. After Week 48 all subjects will receive open-label AMG 145 for up to 2 years (or 
until the investigator’s recommendation for discontinuation, Amgen’s recommendation for 
discontinuation, the subject’s decision to discontinue for any reason, or until an administrative 
decision is made to close the study). 
Sample Size:  The number of subjects entering this study will depend on the number of subjects 
completing their respective AMG 145 parent studies and willingness to enroll.  Approximately 
4428 subjects are expected to participate in this study.   
Summary of Subject Eligibility Criteria:  Subjects who complete a qualifying AMG 145 protocol 
and do not discontinue IP in the parent study for any reason including an adverse event will be 
eligible for this study.  For a full list of eligibility criteria, please refer to Section 4.1 and 
Section 4.2. 
Amgen Investigational Product Dosage and Administration: AMG 145 will be administered 
via subcutaneous injection using a spring-based prefilled 1.0 mL auto-injector/pen (AI/Pen) or 
when available, a 3.5 mL Personal Injector. 
AMG 145 will be administered via 1 of 2 regimens: 
 
AMG 145 140 mg SC Q2W (1 prefilled AI/Pen injection) or 
 
AMG 145 420 mg SC QM (3 prefilled AI/Pen injections or 1 Personal Injector, once 
made available) 


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Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 8 of 65 
CONFIDENTIAL 
 
Study Glossary 
Abbreviation or Term 
Definition/Explanation 
AE 
Adverse event 
AHA 
American Heart Association 
AI/pen 
Prefilled Autoinjector/pen 
ALP 
Alkaline phosphatase 
ALT (SGPT) 
Alanine aminotransferase (serum glutamic-pyruvic transaminase) 
ApoA1 
Apolipoprotein A-1 
ApoB 
Apolipoprotein B 
AST (SGOT) 
Aspartate aminotransferase (serum glutamic-oxaloacetic 
transaminase) 
BP 
Blood pressure 
CAD 
Coronary artery disease 
CBC 
Complete blood count 
CEC 
Clinical Events Committee 
CK 
Creatine kinase 
CHD 
Coronary heart disease 
CRP 
C-reactive protein 
CVD 
Cardiovascular disease 
CTCAE 
NCI Common Terminology Criteria for AEs 
Day 1 
Defined as the first day that protocol-specified investigational 
product is administered to the subject.   
DILI 
Drug-induced liver injury 
eCRF 
 
EDC  
Electronic case report form 
 
Electronic Data Capture  
End of treatment 
Defined as the last assessment for the protocol-specified treatment 
phase of the study for an individual subject 
EOS 
End-of-study for individual subject 
EU 
European Union 
FAS 
Full analysis set 
FSH 
Follicle-stimulating hormone 
GCP 
HCV 
Good Clinical Practice 
Hepatitis C Virus 
HDL-C 
High density lipoprotein cholesterol 
HepG2 cells 
Human hepatocellular carcinoma cell line 
HR 
Heart Rate 
hsCRP 
High sensitivity CRP 


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Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 26 of 65 
CONFIDENTIAL 
 
Injector at appropriate storage conditions until further instructions are received from 
Amgen.   
The investigator is responsible for ensuring that all product complaints observed by the 
investigator or reported by the subject that occur after signing of the ICF through 30 days 
after the last dose of IP or EOS, whichever is later, are reported to Amgen within 
24 hours of discovery or notification of the product complaint.   
For more details regarding the identification and reporting of product and device 
complaints, refer to the IPIM and the IFU. 
6.3 
Concomitant Therapy, Physical Exercise, and Diet 
Throughout the study, investigators may prescribe any concomitant medications or 
treatments deemed necessary to provide adequate supportive care except for those 
listed in Section 6.4.  Background lipid lowering concomitant medications should be 
stable throughout study participation. 
Subjects should maintain baseline level of exercise during the first year of study 
participation.  Subjects will be required to refrain from unaccustomed intensive exercise 
(eg, heavy lifting or long runs) 48 hours prior to each visit. 
6.4 
Excluded Treatments During Study Period 
The use of magnesium or aluminum hydroxide-containing antacids is not recommended 
within the period of two hours before and two hours after dosing with statins given the 
potential for interference with absorption.   
7. 
STUDY PROCEDURES 
Written informed consent must be obtained and will be implemented before protocol 
specific procedures are carried out.  The risks and benefits of participating in the study 
will be verbally explained to each potential subject prior to entering into the study.  The 
procedures to be performed at each clinic visit are described below and are summarized 
in Appendix A IP administered in clinic should not be administered until all study 
procedures are completed at each visit. 
Subject visit schedule will differ based upon 3 factors:  randomization, selection of Q2W 
or QM regimen, and prior experience with self-injection of AMG 145.  Subjects 
randomized to AMG 145 + SOC without previous experience with self-injection of 
AMG 145 will have additional IP training visits at time of study start. At Week 48, a 
similar training schedule will be utilized for subjects randomized to SOC-alone at Day 1 


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Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 40 of 65 
CONFIDENTIAL 
 
An adverse device effect (ADE) is any adverse event related to the use of a medical 
device.  Adverse device effects include adverse events resulting from insufficient or 
inadequate instructions for use, adverse events resulting from any malfunction of the 
device, or adverse events resulting from use error or from intentional misuse of the 
device. 
9.1.2 
Reporting Procedures for Adverse Events 
The investigator is responsible for ensuring that all adverse events observed by the 
investigator or reported by the subject that occur after enrollment through the EOS are 
reported using the applicable eCRF (eg, Adverse Event Summary eCRF).   
The investigator must assign the following adverse event attributes: 
 
Adverse event diagnosis or syndrome(s), if known (if not known, signs or symptoms) 
 
Dates of onset and resolution (if resolved), 
 
Severity 
 
Assessment of relatedness to IMP: AMG 145 
 
Assessment of relatedness to the device (prefilled Autoinjector/Pen (AI/Pen) or 
3.5 mL Personal Injector), or other protocol-required therapies  
 
Action taken 
The adverse event grading scale used will be the NCI Common Terminology Criteria for 
AEs (CTCAE) grading scale.  The toxicity grading scale used in this study is described in 
Appendix B. 
The investigator must assess whether the adverse event is possibly related to AMG 145 
and/or other protocol-required therapies.  This relationship is indicated by a “yes” or “no” 
response to the question:  Is there a reasonable possibility that the event may have been 
caused by AMG 145 and/or other protocol required therapies?  
The investigator must assess whether the adverse event is possibly related to the 
prefilled AI/pen or 3.5 mL Personal Injector device used to administer IMP: AMG 145.  
The relationship is indicated by a “yes” or “no” response to the question: Is there a 
reasonable possibility that the event may have been caused by the device? 
The investigator must assess whether the adverse event is possibly related to any other 
study-mandated activity or procedure.  This relationship is indicated by a “yes” or “no” 
response to the question: “Is there a reasonable possibility that the event may have 
been caused by a study activity/procedure”? 


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Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 1 of 2 
CONFIDENTIAL 
 
 
Amendment 6 
 
Title:  A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the 
Long-term Safety and Efficacy of AMG 145 
Amgen Protocol Number: 20120138 
EudraCT Number: 2012-004357-83 
OSLER 2  
Open Label Study of Long Ter
 
 
m Evaluation Against LDL-C Trial 
 
Amendment 1 Date :  12 February 2013 
Amendment 2 Date:  30 April 2013 
Superseding Amendment 2 Date:  23 May 2013 
Amendment 3 Date:  15 November 2013 
Superseding Amendment 3 Date:  15 February 2014 
Superseding Amendment 3 Date:  24 February 2014 
Amendment 4 Date:  15 April 2014 
Amendment 5 Date:  19 December 2014 
Amendment 6 Date:  03 April  2015 
 
Rationale: 
This document provides the rationale and detailed list of changes for Amendment 6, 
dated 03 April 2015, from Amendment 5 of the study protocol, dated 19 December 2014. 
The purpose of the amendment is to: 
• 
Update exclusion criteria to include methods of effective birth control in the 
protocol language 


Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 2 of 2 
CONFIDENTIAL 
 
 
Description of Changes: 
Section: Header 
Replace: 
19 December 2014 
With: 
03 April 2015 
Section: Coverpage 
Add: 
Amendment 6 Date:  03 April 2015 
Section: 4.2 Exclusion Criteria 
Second Criterion, Bullet point 2 
Replace: 
o Acceptable methods of effective contraception are defined in the ICF.  Where 
required by local laws, regulations and/or guidelines, additional 
country-specific requirements are outlined in a country-specific protocol 
supplement. 
With: 
o Acceptable methods of effective birth control include: sexual 
abstinence (when this is in line with the preferred and usual lifestyle of 
the subject [periodic abstinence (eg, calendar, ovulation, 
symptothermal, post-ovulation methods), declaration of abstinence for 
the duration of a trial, and withdrawal are not acceptable methods of 
contraception]), surgical contraceptive methods (vasectomy or bilateral 
tubal ligation), use of hormonal birth control methods (pills, shots, 
implants or patches), intrauterine devices (IUDs), or two (2) barrier 
methods (each partner must use one barrier method) with  
spermicide – males must use a condom with spermicide; females must 
choose either a diaphragm with spermicide, OR cervical cap with 
spermicide, OR contraceptive sponge with spermicide. Note: Additional 
medications given during treatment with evolocumab may alter the 
contraceptive requirements. These additional medications may require 
an increase in the number of contraceptive methods and/or length of 
time that contraception is to be utilized after the last dose of 
protocol-required therapies. The investigator is to discuss these 
contraceptive changes with the study subject.  


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Product:  AMG 145 
Protocol Number:  20120138 
Date:  23 May 2013 
Page 1 of 1 
 
Amendment 2 - Superseding Amendment 
Protocol Title:  “A Multicenter, Controlled, Open-label 
Extension (OLE) Study to Assess the Long-term Safety 
and Efficacy of AMG 145” 
Amgen Protocol Number AMG 145  20120138 
 
Amendment Date: 
23 May 2013 
Rationale: 
This protocol is being amended to support feedback received from VHP to include a 
minor administrative change to Protocol Amendment 2.   
 
Description of Changes: 
Section:  Study Schema 
Changes:   
• 
Addition of one blue triangle on Day 1 indicating in-clinic administration of IP.   


Product:  AMG 145 
Protocol Number:  20120138 OSLER 2  
Date:  12 February 2013 
Page 1 of 27 
 
Amendment 1 
Protocol Title:  “A Multicenter, Controlled, Open-label 
Extension (OLE) Study to Assess the Long-term Safety 
and Efficacy of AMG 145” 
Amgen Protocol Number AMG 145  20120138 
 
Amendment Date: 
12 February 2013 
Rationale: 
This protocol is being amended to support feedback received from FDA and our Data 
Monitoring Committee (DMC) to include a standard of care (SOC) group for the first 
year.  Doing so increases the scientific rigor of the study and reduces undue relatedness 
and causality of adverse events in subjects receiving AMG 145. 
Additional major changes include: 
 
Reduction to 2 years duration – to facilitate cost containment as 2+ year data will 
be captured through other OLE/Outcomes studies.   
 
Inclusion of Q2W dose regimen – for consistency with other Phase 3 studies and 
opportunity to allow subjects to experience different dosing regimens  
 
Alignment of assessments with other approved longer term AMG 145 studies, eg, 
118 - for consistency with other Phase 3 studies and pooling of data  
 
Addition of extra visits for AMG 145 naïve subjects requiring training on use of 
prefilled AI/pen – to improve opportunity for successful in-home use 
administration of AMG 145 

SAP_001.pdf: 
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