CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 301 enrolled
Drug / intervention
Enlicitide +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06450366
NCT06450366Phase 3Completed

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

Merck Sharp & Dohme LLC·interventional·Posted Jun 10, 2024·Updated Mar 27, 2026

In Brief

A Phase 3 clinical trial evaluating Enlicitide, Ezetimibe, and 4 other interventions for Hypercholesterolemia. Completed, enrolled 301 participants across 35 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Canada, France, Israel, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20252026
First PostedJun 10, 2024
Enrollment StartJul 8, 2024
Primary CompletionFeb 14, 2025
Study CompletionMar 28, 2025
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.1 years ago

Interventions

Enlicitidedrug

Oral tablet

Ezetimibedrug

Oral tablet

Bempedoic Aciddrug

Oral capsule

Placebo for Enlicitideother

enlicitide-matching placebo oral tablet

Placebo for Ezetimibeother

ezetimibe-matching placebo oral tablet

Placebo for Bempedoic Acidother

bempedoic acid-matching placebo oral capsule