Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
MENDEL
A Randomized, Placebo- and Ezetimibe-controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects With a 10-year Framingham Risk Score of 10% or Less
1 other identifier
interventional
411
5 countries
58
Brief Summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2011
Shorter than P25 for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedStudy Start
First participant enrolled
July 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2012
CompletedResults Posted
Study results publicly available
October 5, 2015
CompletedNovember 8, 2022
November 1, 2022
8 months
June 16, 2011
September 3, 2015
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was measured using ultracentrifugation.
Baseline and Week 12
Secondary Outcomes (5)
Change From Baseline in LDL-C at Week 12
Baseline and Week 12
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Baseline and Week 12
Study Arms (9)
Placebo Q2W
PLACEBO COMPARATORParticipants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Placebo Q4W
PLACEBO COMPARATORParticipants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Ezetimibe
ACTIVE COMPARATORParticipants received 10 mg ezetimibe orally once a day for 12 weeks.
Evolocumab 70 mg Q2W
EXPERIMENTALParticipants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 105 mg Q2W
EXPERIMENTALParticipants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 140 mg Q2W
EXPERIMENTALParticipants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 280 mg Q4W
EXPERIMENTALParticipants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 350 mg Q4W
EXPERIMENTALParticipants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 420 mg Q4W
EXPERIMENTALParticipants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Interventions
Administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Male or female ≥ 18 to ≤ 75 years of age
- Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and \< 190 mg/dL
- Framingham risk score of 10% or less
- Fasting triglycerides \< 400 mg/dL
You may not qualify if:
- History of coronary heart disease
- New York Heart Association (NYHA) II - IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (58)
Research Site
Birmingham, Alabama, 35216, United States
Research Site
Little Rock, Arkansas, 72205, United States
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Encinitas, California, 92024, United States
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Inglewood, California, 90301, United States
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San Diego, California, 92111, United States
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Tustin, California, 92780, United States
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DeLand, Florida, 32720, United States
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Jacksonville, Florida, 32216, United States
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Jacksonville, Florida, 32223, United States
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Miami, Florida, 33143, United States
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Miami, Florida, 33144, United States
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Ponte Vedra, Florida, 32081, United States
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Sanford, Florida, 32771, United States
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Decatur, Georgia, 30035, United States
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Chicago, Illinois, 60610, United States
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Indianapolis, Indiana, 46260, United States
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Louisville, Kentucky, 40213, United States
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Bethesda, Maryland, 20817, United States
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Brockton, Massachusetts, 02301, United States
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Brooklyn Center, Minnesota, 55430, United States
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Las Vegas, Nevada, 89148, United States
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Endwell, New York, 13760, United States
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New Windsor, New York, 12553, United States
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Raleigh, North Carolina, 27609, United States
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Raleigh, North Carolina, 27612, United States
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Fargo, North Dakota, 58103, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45246, United States
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Cleveland, Ohio, 44122, United States
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Norman, Oklahoma, 73069, United States
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Oklahoma City, Oklahoma, 73103, United States
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Duncansville, Pennsylvania, 16635, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Rapid City, South Dakota, 57702, United States
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Arlington, Texas, 76014, United States
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Boerne, Texas, 78006, United States
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San Antonio, Texas, 78205, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23294, United States
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Renton, Washington, 98057, United States
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Seattle, Washington, 98122, United States
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Maroubra, New South Wales, 2035, Australia
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Carina Heights, Queensland, 4152, Australia
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Anthée, 5520, Belgium
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Dour, 7370, Belgium
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Gozée, 6534, Belgium
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Gribomont, 6887, Belgium
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Halen, 3545, Belgium
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Ham, 3945, Belgium
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Linkebeek, 1630, Belgium
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Retie, 2470, Belgium
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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
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Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Aalborg, 9000, Denmark
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Ballerup Municipality, 2750, Denmark
Research Site
Vejle, 7100, Denmark
Related Publications (1)
Koren MJ, Scott R, Kim JB, Knusel B, Liu T, Lei L, Bolognese M, Wasserman SM. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2012 Dec 8;380(9858):1995-2006. doi: 10.1016/S0140-6736(12)61771-1. Epub 2012 Nov 6.
PMID: 23141812BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 17, 2011
Study Start
July 6, 2011
Primary Completion
March 2, 2012
Study Completion
March 2, 2012
Last Updated
November 8, 2022
Results First Posted
October 5, 2015
Record last verified: 2022-11