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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 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.

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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.

Conditions Studied

Arteriosclerosis Hypercholesterolaemia

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

FieldValue
Enrollment Target 14,550 participants
Start Date 2023-10-09
Est. Completion 2029-11-29
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06008756

The ClinicalTrials.gov registry entry for NCT06008756 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 14,550 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 251-participant average among 5 other Arteriosclerosis trials with a reported enrollment target (5697% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.