A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides

Phase 2 Completed 177 enrolled Esperion Therapeutics, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.

Timeline

Start: 2010-12
Primary completion: 2011-08-23
Completion: 2011-08-23

Outcome

Met primary endpoint

paper versus a reduction of 2.1 ± 2.2% with placebo (all, p < 0.0001) PMID 23770179 ↗

Publications

Results Ballantyne CM, Davidson MH, Macdougall DE, Bays HE, Dicarlo LA, Rosenberg NL, Margulies J, Newton RS. Efficacy and safety of a novel dual modulator of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase in patients with hypercholesterolemia: results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. J Am Coll Cardiol. 2013 Sep 24;62(13):1154-62. doi: 10.1016/j.jacc.2013.05.050. Epub 2013 Jun 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bempedoic acid	Small molecule	40 mg	—
Subject	Bempedoic acid	Small molecule	80 mg	—
Subject	Bempedoic acid	Small molecule	120 mg	—