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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)

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Ezetimibe
Placebo to Evolocumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring High cholesterol, Proprotein convertase subtilisin/kexin type 9 (PCSK9), Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo Q2W

Placebo Q4W

Ezetimibe

Evolocumab 70 mg Q2W

Evolocumab 105 mg Q2W

Evolocumab 140 mg Q2W

Evolocumab 280 mg Q4W

Evolocumab 350 mg Q4W

Evolocumab 420 mg Q4W

Arm Description

Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.

Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.

Participants received 10 mg ezetimibe orally once a day for 12 weeks.

Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was measured using ultracentrifugation.

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2011
Last Updated
November 4, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01375777
Brief Title
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
Acronym
MENDEL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2011 (Actual)
Primary Completion Date
March 2, 2012 (Actual)
Study Completion Date
March 2, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
High cholesterol, Proprotein convertase subtilisin/kexin type 9 (PCSK9), Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Q2W
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Arm Title
Placebo Q4W
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Arm Title
Ezetimibe
Arm Type
Active Comparator
Arm Description
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
Arm Title
Evolocumab 70 mg Q2W
Arm Type
Experimental
Arm Description
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Arm Title
Evolocumab 105 mg Q2W
Arm Type
Experimental
Arm Description
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Arm Title
Evolocumab 140 mg Q2W
Arm Type
Experimental
Arm Description
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Arm Title
Evolocumab 280 mg Q4W
Arm Type
Experimental
Arm Description
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Arm Title
Evolocumab 350 mg Q4W
Arm Type
Experimental
Arm Description
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Arm Title
Evolocumab 420 mg Q4W
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Zetia
Intervention Description
Administered orally once a day
Intervention Type
Other
Intervention Name(s)
Placebo to Evolocumab
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
LDL-C was measured using ultracentrifugation.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in LDL-C at Week 12
Description
LDL-C was measured using ultracentrifugation.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Research Site
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Research Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32223
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Research Site
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Research Site
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30035
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Research Site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Research Site
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Research Site
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Research Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Research Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Research Site
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Research Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Research Site
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Research Site
City
Carina Heights
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
Research Site
City
Anthée
ZIP/Postal Code
5520
Country
Belgium
Facility Name
Research Site
City
Dour
ZIP/Postal Code
7370
Country
Belgium
Facility Name
Research Site
City
Gozee
ZIP/Postal Code
6534
Country
Belgium
Facility Name
Research Site
City
Gribomont
ZIP/Postal Code
6887
Country
Belgium
Facility Name
Research Site
City
Halen
ZIP/Postal Code
3545
Country
Belgium
Facility Name
Research Site
City
Ham
ZIP/Postal Code
3945
Country
Belgium
Facility Name
Research Site
City
Linkebeek
ZIP/Postal Code
1630
Country
Belgium
Facility Name
Research Site
City
Retie
ZIP/Postal Code
2470
Country
Belgium
Facility Name
Research Site
City
Bay Roberts
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A0A 1G0
Country
Canada
Facility Name
Research Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Research Site
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Research Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23141812
Citation
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.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

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