CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
bempedoic acid 180mg +2 moredrug
Likely dose
Bempedoic acid 180 mg orally once dailyAI-extracted
Key inclusion· 3
  • ✓Age ≥18 years
  • ✓Fasting LDL-C ≥160 mg/dL at screening AND ≥70 mg/dL after PCSK9i therapy
  • ✓Non-pregnant, non-lactating women and men
Key exclusion· 13
  • ✕Heterozygous or homozygous familial hypercholesterolemia
  • ✕Fasting triglycerides ≥500 mg/dL
  • ✕eGFR <30 mL/min/1.73 m²
  • ✕Known cardiovascular disease, peripheral arterial disease, or cerebrovascular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03193047
NCT03193047Phase 2Completed
CompareCT.gov

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

Esperion Therapeutics, Inc.·interventional·Posted Jun 20, 2017·Updated Apr 3, 2020

In Brief

A Phase 2 clinical trial evaluating bempedoic acid 180mg, placebo, and 1 other intervention for Hypercholesterolemia. Completed, enrolled 59 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 20, 2017
Enrollment StartApr 7, 2017
Primary CompletionJan 29, 2018
Study CompletionFeb 19, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.0 years ago

Interventions

bempedoic acid 180mgdrug

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

placeboother

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

evolocumabdrug

Monthly PCSK9i (evolocumab) background therapy