Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06008756 · ClinicalTrials.gov registry record · Phase 3
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
A Phase 3 study of Arteriosclerosis and Hypercholesterolaemia, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 14,550
- Enrollment target
- 20
- Study locations
NCT06008756: Active Phase 3 study of Arteriosclerosis and Hypercholesterolaemia, sponsored by Merck Sharp & Dohme.
NCT06008756 is a Phase 3 study of Arteriosclerosis and Hypercholesterolaemia that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 14,550 participants, above the 251-participant average among 5 other Arteriosclerosis trials with a reported enrollment target (5697% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06008756, a Phase 3 study of Arteriosclerosis and Hypercholesterolaemia, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 14,550 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Time to the first occurrence of CHD death-based MACE-plus, which is defined as any of the following: coronary heart disease death, myocardial infarction (MI), ischemic stroke (fatal and nonfatal), acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or peripheral).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Enlicitide Decanoate
Study Locations (20)
California
- National Heart Institute-Research ( Site 0077) - Beverly Hills
- UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0130) - La Jolla
- Chemidox Clinical Trials ( Site 0145) - Lancaster
- Velocity Clinical Research, Westlake ( Site 0039) - Los Angeles
- Carbon Health - Pasadena ( Site 0149) - Pasadena
- Carbon Health - San Mateo - Hillsdale Mall ( Site 0151) - San Mateo
- America Clinical Trials-Research Dept ( Site 0104) - Tarzana
- Premiere Medical Center ( Site 0093) - Toluca Lake
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0058) - Torrance
Alabama
- Advanced Cardiovascular - Alexander City ( Site 0156) - Alexander City
- Central Research Associates ( Site 0118) - Birmingham
- St. Vincent's Birmingham Hospital ( Site 0181) - Birmingham
- Central Alabama Research ( Site 0109) - Birmingham
- Alliance for Multispecialty Research, LLC ( Site 0076) - Daphne
- G&L Research ( Site 0042) - Foley
Arizona
- NextStage Clinical Research - Phoenix - (01) ( Site 0191) - Glendale
- Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0066) - Phoenix
Colorado
- University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0146) - Aurora
- South Denver Cardiology Associates ( Site 0167) - Littleton
Arkansas
- Medical Investigations Inc. ( Site 0188) - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,550 participants |
| Start Date | 2023-10-09 |
| Est. Completion | 2029-11-29 |
| Phase | Phase 3 |
What the registry record for NCT06008756 still lists
NCT06008756 is an interventional study that assigns participants to a tested intervention. Its 14,550 participants enrollment target places it among the larger protocols in the corpus, above the 251-participant average among 5 other Arteriosclerosis trials with a reported enrollment target (5697% higher).
The record links to 2 conditions, with Arteriosclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06008756 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT06008756 about?
NCT06008756 is a clinical study titled "Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes". 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 decanoat...
What is the current status of trial NCT06008756?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 14,550 participants. The study started on 2023-10-09. Estimated completion is 2029-11-29.
What conditions does trial NCT06008756 study?
This clinical trial studies the following conditions: Arteriosclerosis, Hypercholesterolaemia.
What interventions are being tested in trial NCT06008756?
The interventions under investigation include: Placebo (DRUG), Enlicitide Decanoate (DRUG).
Who is sponsoring clinical trial NCT06008756?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06008756 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Arteriosclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
RECRUITING · NA
-
Sapphire 3 CTO Study
COMPLETED · NA
-
Distributed Registry
COMPLETED
-
A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation
COMPLETED · Phase 1
-
CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05359016 · 14,600 participants · NA
Evaluating Innovative Technologies and Approaches to Addressing Cervical Cancer in Gaza and Maputo Cidade Provinces in Mozambique
- NCT05591066 · 14,400 participants · NA
The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now
- NCT06849869 · 14,820 participants · NA
Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change
- NCT00857922 · 15,000 participants
Neurosciences Research Repository
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI