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

NCT03193047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-04-03

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

bempedoic acid 180mg

Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy

OTHER

placebo

Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy

DRUG

evolocumab

Monthly PCSK9i (evolocumab) background therapy

Sponsors & Collaborators

  • Esperion Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ron Haberman, MD · Esperion Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-07
Primary Completion
2018-01-29
Completion
2018-02-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193047 on ClinicalTrials.gov