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A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2025

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At a glance

  • Drugs Bempedoic acid (Primary)
  • Indications Cardiovascular disorders; Coronary artery disease; Hypercholesterolaemia; Intracranial-Arteriosclerosis; Peripheral arterial disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms CLEAR Outcomes; CVOT
  • Sponsors Esperion Therapeutics

Most Recent Events

  • 18 Nov 2025 According to a HLS Therapeutics media release, based on results form this trial the Health Canada has approved NILEMDO (bempedoic acid) for use in Canada and has issued a Notice of Non-Compliance (NON) for NEXLIZET (bempedoic acid and ezetimibe).
  • 08 May 2025 According to an Esperion Therapeutics media release, in Q4 2024, Esperion submitted New Drug Submissions to Health Canada for both NEXLETOL and NEXLIZET1. Under this agreement, HLS will be responsible for obtaining Health Canada approval, which is expected by the end of 2025.
  • 06 May 2025 According to an Esperion Therapeutics media release, post-hoc analysis data from this study was published in Journal of Clinical Lipidology.

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