Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant (CLEAR Serenity)

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

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg Compared to Placebo Added to Background Lipid-Modifying Therapy in Patients With Elevated LDL-C Who Are Statin Intolerant

The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

345

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

  • Canada
      • Brossard, Canada
      • Chicoutimi, Canada
      • Gatineau, Canada
      • London, Canada
      • Longueuil, Canada
      • Mirabel, Canada
      • Montréal, Canada
      • Newmarket, Canada
      • Oakville, Canada
      • Peterborough, Canada
      • Pointe-Claire, Canada
      • Saint-Jérôme, Canada
      • Sarnia, Canada
      • Toronto, Canada
      • Victoriaville, Canada
  • United States
    • Arizona
      • Gilbert, Arizona, United States
    • California
      • Anaheim, California, United States
      • Long Beach, California, United States
      • Sacramento, California, United States
      • Santa Ana, California, United States
      • Torrance, California, United States
      • Ventura, California, United States
    • Connecticut
      • Hamden, Connecticut, United States
    • Florida
      • Daytona Beach, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Miami, Florida, United States
        • Site 1
      • Miami, Florida, United States
        • Site 2
      • Orlando, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Savannah, Georgia, United States
    • Idaho
      • Meridian, Idaho, United States
    • Illinois
      • Evanston, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
      • Waterloo, Iowa, United States
    • Louisiana
      • Monroe, Louisiana, United States
      • Slidell, Louisiana, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New Jersey
      • Somerset, New Jersey, United States
    • New York
      • Binghamton, New York, United States
      • Endwell, New York, United States
      • New Windsor, New York, United States
    • North Carolina
      • Greensboro, North Carolina, United States
      • Morganton, North Carolina, United States
      • Mount Airy, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
      • Marion, Ohio, United States
      • Maumee, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
      • Langhorne, Pennsylvania, United States
    • Rhode Island
      • Cumberland, Rhode Island, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Summerville, South Carolina, United States
    • Tennessee
      • Jackson, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Dallas, Texas, United States
        • Site 1
      • Dallas, Texas, United States
        • Site 2
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Clinton, Utah, United States
    • Virginia
      • Hampton, Virginia, United States
    • Wisconsin
      • Kenosha, Wisconsin, United States

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:

  • Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
  • Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
  • Be statin-intolerant (unable to tolerate 2 or more statins)

Exclusion Criteria:

  • Total fasting triglyceride ≥500 mg/dL
  • Renal dysfunction or nephrotic syndrome or history of nephritis
  • Body Mass Index (BMI) ≥50 kg/m2
  • Significant cardiovascular disease or cardiovascular event in the past 3 months

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bempedoic acid
bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
Drug: bempedoic acid
bempedoic acid 180 mg tablet
Other Names:
  • ETC-1002
Placebo Comparator: placebo
Matching placebo tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
Other: placebo
Matching placebo tablet
Other Names:
  • placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline; Week 12
PCFB was calculated as the ([post-Baseline (BL) value minus the BL value] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. PCFB in LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.
Baseline; Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in LDL-C at Week 24
Time Frame: Baseline; Week 24
PCFB was calculated as the ([post-BL value minus the BL value] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available then that single value was used as BL. PCFB in LDL-C was analyzed using ANCOVA, with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.
Baseline; Week 24
Percent Change From Baseline in the Lipid Profile at Week 12
Time Frame: Baseline; Week 12
PCFB was calculated as: ([post-BL value minus the BL value] divided by the BL value) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. apoB and TC BL were defined as the last non-missing value on/prior to Day 1. PCFB was analyzed using ANCOVA, with treatment and group stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing data at Week 12 who were no longer taking study treatment (ST), missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking ST, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.
Baseline; Week 12
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 12
Time Frame: Baseline; Week 12
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline for hsCRP is defined as the last non-missing value on or prior to Day 1. Percent change from Baseline in hsCRP, non-parametric (Wilcoxon rank-sum test) analysis with Hodges-Lehmann estimates and confidence interval was performed.
Baseline; Week 12
Absolute Change From Baseline in LDL-C at Week 12 and Week 24
Time Frame: Baseline; Week 12; Week 24
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 last two non-missing values on or prior to Day 1.
Baseline; Week 12; Week 24

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

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)

November 16, 2016

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

March 16, 2018

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 9, 2016

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

  • 1002-046

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 Hypercholesterolemia

Clinical Trials on bempedoic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe