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)

November 4, 2022 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

411

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Maroubra, New South Wales, Australia, 2035
        • Research Site
    • Queensland
      • Carina Heights, Queensland, Australia, 4152
        • Research Site
  • Belgium
      • Anthée, Belgium, 5520
        • Research Site
      • Dour, Belgium, 7370
        • Research Site
      • Gozee, Belgium, 6534
        • Research Site
      • Gribomont, Belgium, 6887
        • Research Site
      • Halen, Belgium, 3545
        • Research Site
      • Ham, Belgium, 3945
        • Research Site
      • Linkebeek, Belgium, 1630
        • Research Site
      • Retie, Belgium, 2470
        • Research Site
  • Canada
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • Research Site
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M9W 4L6
        • Research Site
    • Quebec
      • Granby, Quebec, Canada, J2G 8Z9
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Encinitas, California, United States, 92024
        • Research Site
      • Inglewood, California, United States, 90301
        • Research Site
      • San Diego, California, United States, 92111
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Jacksonville, Florida, United States, 32223
        • Research Site
      • Miami, Florida, United States, 33144
        • Research Site
      • Miami, Florida, United States, 33143
        • Research Site
      • Ponte Vedra, Florida, United States, 32081
        • Research Site
      • Sanford, Florida, United States, 32771
        • Research Site
    • Georgia
      • Decatur, Georgia, United States, 30035
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Research Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Research Site
    • New York
      • Endwell, New York, United States, 13760
        • Research Site
      • New Windsor, New York, United States, 12553
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45246
        • Research Site
      • Cleveland, Ohio, United States, 44122
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Research Site
      • Boerne, Texas, United States, 78006
        • Research Site
      • San Antonio, Texas, United States, 78205
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Research Site
      • Richmond, Virginia, United States, 23294
        • Research Site
    • Washington
      • Renton, Washington, United States, 98057
        • Research Site
      • Seattle, Washington, United States, 98122
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of coronary heart disease
  • New York Heart Association (NYHA) II - IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Other: Placebo to Evolocumab
Administered by subcutaneous injection
Placebo Comparator: Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Other: Placebo to Evolocumab
Administered by subcutaneous injection
Active Comparator: Ezetimibe
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
Drug: Ezetimibe
Administered orally once a day
Other Names:
  • Zetia
Experimental: Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Evolocumab 105 mg Q2W
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Evolocumab 350 mg Q4W
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation.
Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2011

Primary Completion (Actual)

March 2, 2012

Study Completion (Actual)

March 2, 2012

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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