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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia.

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Aug 2026

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At a glance

  • Drugs Enlicitide (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms CORALreef HeFH
  • Sponsors Merck Sharp & Dohme

Most Recent Events

  • 16 Jul 2026 Results presented in the Merck Media Release
  • 16 Jul 2026 According to a Merck media release, company announced the U.S. Food and Drug Administration (FDA) has approved LIPFENDRA (enlicitide) tablets 20 mg as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
  • 09 Nov 2025 According to Merck media release, Merck plans to share data from this trial, along with data from CORALreef Lipids and CORALreef AddOn with regulatory authorities worldwide.

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