Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

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) 180mg QD When Added to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)-Inhibitor Therapy

The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.

Study Overview

Study Type

Interventional

Enrollment (Actual)

59

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

    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center

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:

  • Age ≥18 years or legal age of majority depending on regional law
  • Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL
  • Men and nonpregnant, nonlactating women

Exclusion Criteria:

  • Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia
  • Total fasting TG ≥500 mg/dL
  • Renal dysfunction or a glomerulonephropathy; eGFR <30 mL/min/1.73 m2
  • Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or cerebrovascular disease (CD)
  • History of type 1 or type 2 diabetes
  • Uncontrolled hypertension
  • Uncontrolled hypothyroidism
  • Liver disease or dysfunction
  • Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass)
  • History of hematologic or coagulation disorders
  • History of malignancy (except non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ)
  • Unexplained creatine kinase (CK) >3 × ULN
  • Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib
  • Pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 30 days after the end of treatment

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 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
Other Names:
  • ETC-1002
Monthly PCSK9i (evolocumab) background therapy
Other Names:
  • Repatha
Placebo Comparator: placebo
Matching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
Monthly PCSK9i (evolocumab) background therapy
Other Names:
  • Repatha
Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy

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 Month 2
Time Frame: Baseline; Month 2
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 average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate. Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward).
Baseline; Month 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in LDL-C at Month 1
Time Frame: Baseline; Month 1
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 average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis.
Baseline; Month 1
Absolute Change From Baseline in LDL-C at Month 1 and Month 2
Time Frame: Baseline; Month 1 and Month 2
Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the average of the Screening Visit 4 and the Day 1 value. If only 1 value is available, then that single value is used as Baseline. Change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
Baseline; Month 1 and Month 2
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
Time Frame: Baseline; Month 1 and Month 2
Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline apolipoprotein B (apoB) is defined as the Day 1 value. Baseline total cholesterol (TC) and non-high-density lipoprotein cholesterol (non-HDL-C) are defined as the average of the Month -1 (Screening Visit 4) and the Day 1 (Treatment Visit 1) values. If a missing value presented at Month -1 or Day 1, then the last non-missing value prior to the first dose of double-blind study medication (including unscheduled assessments) within Month -1 and Day 1 was used to compute the Baseline measurements. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
Baseline; Month 1 and Month 2
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2
Time Frame: Baseline; Month 1 and Month 2
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 Day 1 value. Percent change from Baseline was analyzed using a non-parametric approach. Missing Month 2 data were handled by LOCF. Observed data were used for analysis at Month 1.
Baseline; Month 1 and Month 2
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Time Frame: up to Month 2 (until 30 days after last dose)
Treatment-emergent AEs (TEAEs) and SAEs (TESAEs) were reported and defined as any AE that began or worsened after the first dose of investigational medicinal product.
up to Month 2 (until 30 days after last dose)
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2
Time Frame: Month 1 and Month 2
The number of participants with ALT or AST >3x ULN was measured.
Month 1 and Month 2

Collaborators and Investigators

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

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)

April 7, 2017

Primary Completion (Actual)

January 29, 2018

Study Completion (Actual)

February 19, 2018

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 20, 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

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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