NCT06008756

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14,550 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.

Conditions

• Arteriosclerosis
• Hypercholesterolaemia

Interventions

Type	Name	Description
DRUG	Enlicitide Decanoate	Enlicitide Decanoate 20 mg tablet taken by mouth.
DRUG	Placebo	Placebo tablet matched to enlicitide decanoate taken by mouth.

Timeline

• Start date: 2023-10-09
• Primary completion: 2029-11-29
• Completion: 2029-11-29
• First posted: 2023-08-24
• Last updated: 2025-11-13

Locations

669 sites across 29 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Puerto Rico, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study