Clinical Trials
A Cardiovascular Outcomes Trial Is in Progress
ESPERION has initiated a global cardiovascular outcomes trial (CVOT)—CLEAR Outcomes—and plans to submit the trial results to health authorities in 2023 for potential inclusion in product labeling.
Cardiovascular Risk Reduction TRIAL1,2
ASCVD/High-risk Primary
Prevention
CLEAR Outcomes:
(N=14,032)
4.75
years
CLEAR Outcomes (1002-043) is a Phase 3, event-driven, randomized, multicenter, double-blind, placebo-controlled trial designed to evaluate whether treatment with bempedoic acid reduces the risk of cardiovascular events. The primary endpoint of the study is the effect of bempedoic acid on major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization; also referred to as “four-component major adverse cardiovascular events”). It is designed to provide 90% power to detect an approximately 15% relative risk reduction in the primary endpoint in the bempedoic acid treatment group as compared to the placebo group, and is expected to complete with a minimum of 1,620 patients experiencing the primary endpoint. The study enrolled 14,032 patients at over 1,400 sites in 32 countries. Based on estimated cardiovascular event rates, we expect the CLEAR Outcomes trial to conclude in the second half of 2022.1-3

For a comprehensive look at inclusion and exclusion criteria, and endpoint information, please visit www.clinicaltrials.gov.
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References: 1. Esperion completes patient enrollment in the global CLEAR cardiovascular outcomes trial for bempedoic acid [press release]. Ann Arbor, Michigan: Esperion Therapeutics, Inc.; September 5, 2019. Accessed January 16, 2020. 2. Ruscica M, Banach M, Sahebkar A, Corsini A, Sirtori CR. ETC-1002 (Bempedoic acid) for the management of hyperlipidemia: from preclinical studies to phase 3 trials. Exp Opin Pharmacother. 2019. doi:10.1080/14656566.2019.1583209. 3. Data on file. Esperion Therapeutics, Inc. 2020.