Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 (MENDEL-2)

November 4, 2022 updated by: Amgen

A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

615

Phase

  • Phase 3

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
      • Darlinghurst, New South Wales, Australia, 2010
        • Research Site
      • Maroubra, New South Wales, Australia, 2035
        • Research Site
    • Queensland
      • Carina Heights, Queensland, Australia, 4152
        • Research Site
      • Sherwood, Queensland, Australia, 4075
        • Research Site
  • Belgium
      • Anthée, Belgium, 5520
        • Research Site
      • Bruxelles, Belgium, 1080
        • 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
      • Tessenderlo, Belgium, 3980
        • 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
  • France
      • Gières, France, 38610
        • Research Site
      • Grenoble Cedex 9, France, 38043
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Research Site
      • Seoul, Korea, Republic of, 120-752
        • Research Site
      • Seoul, Korea, Republic of, 138-736
        • Research Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Research Site
    • Gauteng
      • Alberton, Gauteng, South Africa, 1449
        • Research Site
      • Johannesburg, Gauteng, South Africa, 2196
        • Research Site
    • Western Cape
      • Parow, Western Cape, South Africa, 7505
        • Research Site
      • Somerset West, Western Cape, South Africa, 7130
        • Research Site
      • Worcester, Western Cape, South Africa, 6850
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Research Site
      • Kaohsiung, Taiwan, 83301
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
  • Turkey
      • Istanbul, Turkey, 34093
        • Research Site
      • Istanbul, Turkey, 34662
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Carmichael, California, United States, 95608
        • Research Site
      • Encinitas, California, United States, 92024
        • Research Site
      • San Diego, California, United States, 92111
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Miami, Florida, United States, 33144
        • Research Site
      • Ponte Vedra, Florida, United States, 32081
        • Research Site
      • Sanford, Florida, United States, 32771
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • 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
      • Edina, Minnesota, United States, 55435
        • Research Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • 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
      • Akron, Ohio, United States, 44311
        • Research Site
      • Cincinnati, Ohio, United States, 45236
        • Research Site
      • Cincinnati, Ohio, United States, 45246
        • Research Site
      • Cincinnati, Ohio, United States, 45212
        • 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
      • Anderson, South Carolina, United States, 29621
        • Research Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Research Site
    • Texas
      • Boerne, Texas, United States, 78006
        • Research Site
      • Dallas, Texas, United States, 75230
        • Research Site
      • San Antonio, Texas, United States, 78205
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • 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, 98104
        • 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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female ≥ 18 to ≤ 80 years of age
  • National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less
  • Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL
  • Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

  • History of coronary heart disease
  • New York Heart Association (NYHA) III or IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
  • Uncontrolled hypothyroidism or hyperthyroidism

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) and placebo tablets once a day for up to 12 weeks.
Biological: Placebo to Evolocumab
Administered by subcutaneous injection
Other: Placebo to Ezetimibe
Administered orally once daily
Placebo Comparator: Placebo QM
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
Biological: Placebo to Evolocumab
Administered by subcutaneous injection
Other: Placebo to Ezetimibe
Administered orally once daily
Active Comparator: Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Biological: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Ezetimibe
Administered orally once a day
Other Names:
  • Zetia
Active Comparator: Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Biological: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Ezetimibe
Administered orally once a day
Other Names:
  • Zetia
Experimental: Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Other: Placebo to Ezetimibe
Administered orally once daily
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Experimental: Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Other: Placebo to Ezetimibe
Administered orally once daily
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Time Frame: Weeks 10 and 12
Weeks 10 and 12
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Time Frame: Week 12
Week 12
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Lipoprotein (a) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in VLDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in 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)

January 21, 2013

Primary Completion (Actual)

October 10, 2013

Study Completion (Actual)

October 29, 2013

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 9, 2013

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

  • 20110114

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.

Clinical Trials on Hyperlipidemia

Clinical Trials on Placebo to Evolocumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe