Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C

March 20, 2020 updated by: Esperion Therapeutics, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Triplet Therapy With Bempedoic Acid (ETC 1002) 180 mg, Ezetimibe 10 mg, and Atorvastatin 20 mg in Patients With Elevated LDL C

The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

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

  • United States
    • Illinois
      • Champaign, Illinois, United States, 61820
        • PMG Research of Christie Clinic
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • PMG Research of Cary
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte
      • Charlotte, North Carolina, United States, 28277
        • Sensenbrenner Primary Care
      • Hickory, North Carolina, United States, 28601
        • PMG Research of Hickory
      • Raleigh, North Carolina, United States, 27609
        • PMG Research of Raleigh
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount
      • Salisbury, North Carolina, United States, 28144
        • PMG Research Salisbury
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • PMG Research of Charleston
    • Virginia
      • Virginia Beach, Virginia, United States, 23451
        • Hampton Roads Center for Clinical Research

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fasting LDL-cholesterol between 130 - 189 mg/dL at screening following washout of all LDL-C-lowering drugs and nutritional supplements
  • Men and nonpregnant, nonlactating women
  • Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and nutritional supplements for 12 weeks

Exclusion Criteria:

  • Fasting blood triglycerides greater than or equal to 400 mg/dL
  • Body Mass Index (BMI) greater than 50 kg/m2
  • History of clinically significant cardiovascular disease
  • History of type 1 or type 2 diabetes

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Triplet Therapy
Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
Drug: Bempedoic acid 180mg
bempedoic acid 180 mg
Other Names:
  • ETC-1002
Drug: Ezetimibe 10mg
ezetimibe 10 mg
Other Names:
  • Zetia
Drug: Atorvastatin 20mg
atorvastatin 20 mg
Other Names:
  • Lipitor
PLACEBO_COMPARATOR: placebo
Matching placebos taken orally, daily.
Other: Placebo
placebo

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 6
Time Frame: Baseline; Week 6
Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Percent change from Baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing LDL-C values were imputed using last observation carried forward (LOCF), with only post-Baseline values carried forward. If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.
Baseline; Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Lipid Profile Parameters at Week 6
Time Frame: Baseline; Week 6
Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Baseline apolipoprotein B (apoB) was measured only at predose/Day 1. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing values were imputed using LOCF, with only post-Baseline values carried forward. non-HDL-C, non-high-density lipoprotein cholesterol; TC, total cholesterol; TG, triglycerides; HDL-C, high-density lipoprotein cholesterol.
Baseline; Week 6
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6
Time Frame: Baseline; Week 6
Percent change is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the predose Day 1/Week 0 (Treatment Visit 1) value. If only one value is available either at Week -1 (Screening Visit 2) or Week 0 (Treatment Visit 1), then that value is used as Baseline. Missing values were imputed using LOCF, with only post-Baseline values carried forward.
Baseline; Week 6
Number of Participants With LDL-C <70 mg/dL at Week 6
Time Frame: Week 6
Analysis was based on LOCF values. If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.
Week 6
Number of Participants With LDL-C Reduction ≥50% From Baseline at Week 6
Time Frame: Baseline; Week 6
If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.
Baseline; Week 6

Collaborators and Investigators

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

Sponsor

Esperion Therapeutics, Inc.

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

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 19, 2017

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

July 5, 2017

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (ACTUAL)

February 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1002-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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