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
Sponsor: Merck Sharp & Dohme LLC
Listed as NCT06008756, this observational or N/A phase trial focuses on Arteriosclerosis and Hypercholesterolaemia and remains ongoing. Sponsored by Merck Sharp & Dohme LLC, it has been updated 28 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
28 versions recorded-
Apr 28, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE3 → None
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Dec 2025 — Apr 2026 [monthly]
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▶ Show 23 earlier versions
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Aug 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE3
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE3
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Dec 2023 — Jan 2024 [monthly]
Recruiting PHASE3
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Nov 2023 — Dec 2023 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Oct 2023 — Nov 2023 [monthly]
Not Yet Recruiting PHASE3
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Sep 2023 — Oct 2023 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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.
Contact Information
- Merck Sharp & Dohme LLC
For direct contact, visit the study record on ClinicalTrials.gov .