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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Arteriosclerosis, Hypercholesterolaemia

In brief

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.

Key facts

Study ID: NCT06008756
Run by: Merck Sharp & Dohme LLC
People needed: 14550
Starts: 2023-10-09
Expected to finish: 2031-11-29
Last updated by the study team: 2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Meets one of the following:
Age ≥18 years with a history of a major atherosclerotic cardiovascular disease (ASCVD) event defined as at least 1 of the following: ≥30 days post MI (presumed Type 1 due to plaque rupture or erosion); ≥30 days post ischemic stroke (presumed due to atherosclerosis); or ≥30 days post successful peripheral (carotid or lower extremity) arterial revascularization (surgical or endovascular) or major (ankle or above) amputation due to atherosclerosis; or
High risk for first major ASCVD event defined as at least 1 of the following: Age ≥50 years with evidence of coronary artery disease; Age ≥50 years with evidence of atherosclerotic cerebrovascular disease; Age ≥50 years with evidence of peripheral arterial disease; or Age ≥60 years with diabetes mellitus and at least one of the following: microvascular disease or urine albumin-creatinine ratio ≥30 mg/mmol within 6 months before Visit 1, daily insulin use, or diabetes for ≥10 years
Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening) as follows:
History of major ASCVD Event: LDL-C ≥70 mg/dL (1.81 mmol/L) OR non-HDL-C ≥100 mg/dL (2.59 mmol/L)
High risk for first major ASCVD Event: LDL-C ≥90 mg/dL (2.33 mmol/L) OR non-HDL-C ≥120 mg/dL (3.11 mmol/L)
Is treated with moderate- or high-intensity statin (± nonstatin lipid-lowering therapy [LLT]) at Visit 1
Is on a stable dose of all background LLTs (including statin and nonstatin agents) for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study

You may not qualify if…

Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
Has New York Heart Association Class IV heart failure, last known Left Ventricular Ejection Fraction ≤25% by any imaging method, or had a Heart Failure hospitalization within 3 months before Visit 1 (Screening)
Has recurrent ventricular tachycardia within 3 months prior to randomization
Has a planned arterial revascularization procedure
Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program
Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout.
Has a fasting triglyceride value ≥400 mg/dL (≥4.52 mmol/L) at Visit 1 (Screening)

Where it is running

Rochester Clinical Research, Inc. ( Site 0098) — Rochester, New York, United States
Corcare ( Site 0511) — Toronto, Ontario, Canada
Advanced Cardiovascular - Alexander City ( Site 0156) — Alexander City, Alabama, United States
Central Research Associates ( Site 0118) — Birmingham, Alabama, United States
St. Vincent's Birmingham Hospital ( Site 0181) — Birmingham, Alabama, United States
Central Alabama Research ( Site 0109) — Birmingham, Alabama, United States
Alliance for Multispecialty Research, LLC ( Site 0076) — Daphne, Alabama, United States
G&L Research ( Site 0042) — Foley, Alabama, United States
NextStage Clinical Research - Phoenix - (01) ( Site 0191) — Glendale, Arizona, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0066) — Phoenix, Arizona, United States
Medical Investigations Inc. ( Site 0188) — Little Rock, Arkansas, United States
National Heart Institute-Research ( Site 0077) — Beverly Hills, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0130) — La Jolla, California, United States
Chemidox Clinical Trials ( Site 0145) — Lancaster, California, United States
Velocity Clinical Research, Westlake ( Site 0039) — Los Angeles, California, United States
Carbon Health - Pasadena ( Site 0149) — Pasadena, California, United States
Carbon Health - San Mateo - Hillsdale Mall ( Site 0151) — San Mateo, California, United States
America Clinical Trials-Research Dept ( Site 0104) — Tarzana, California, United States
Premiere Medical Center ( Site 0093) — Toluca Lake, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0058) — Torrance, California, United States
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0146) — Aurora, Colorado, United States
South Denver Cardiology Associates ( Site 0167) — Littleton, Colorado, United States
Cardiology Associates of Fairfield County, P.C. ( Site 0159) — Stamford, Connecticut, United States
Chase Medical Research, LLC ( Site 0046) — Waterbury, Connecticut, United States
NYU Langone Health ( Site 0099) — New York, New York, United States

Full record on ClinicalTrials.gov

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