CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,912 enrolled
Drug / intervention
Enlicitide Decanoate +1 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/NCT05952856
NCT05952856Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

Merck Sharp & Dohme LLC·interventional·Posted Jul 19, 2023·Updated Sep 10, 2025

In Brief

A Phase 3 clinical trial evaluating Enlicitide Decanoate and Placebo for Hypercholesterolemia and Familial Hypercholesterolemia. Completed, enrolled 2,912 participants across 168 sites in 14 countries.

Detailed Summary

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Familial Hypercholesterolemia
CountriesArgentina, China, Colombia, Germany, Israel, Italy, Japan, Mexico, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedJul 19, 2023
Enrollment StartAug 10, 2023
Primary CompletionJul 28, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 3.0 years ago

Interventions

Enlicitide Decanoatedrug

Oral tablet

Placebodrug

Oral tablet