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A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)

NCT06450366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2026-03-27

Study results available
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Summary

The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.

Conditions

Interventions

DRUG

Enlicitide

Oral tablet

DRUG

Ezetimibe

Oral tablet

DRUG

Bempedoic Acid

Oral capsule

OTHER

Placebo for Enlicitide

enlicitide-matching placebo oral tablet

OTHER

Placebo for Ezetimibe

ezetimibe-matching placebo oral tablet

OTHER

Placebo for Bempedoic Acid

bempedoic acid-matching placebo oral capsule

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-08
Primary Completion
2025-02-14
Completion
2025-03-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • France
  • Israel
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06450366 on ClinicalTrials.gov