NCT06450366

A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Enlicitide	Oral tablet
DRUG	Ezetimibe	Oral tablet
DRUG	Bempedoic Acid	Oral capsule
OTHER	Placebo for Enlicitide	enlicitide-matching placebo oral tablet
OTHER	Placebo for Ezetimibe	ezetimibe-matching placebo oral tablet
OTHER	Placebo for Bempedoic Acid	bempedoic acid-matching placebo oral capsule

Timeline

• Start date: 2024-07-08
• Primary completion: 2025-02-14
• Completion: 2025-03-28
• First posted: 2024-06-10
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

35 sites across 8 countries: United States, Argentina, Canada, France, Israel, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study