At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 303 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.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia.
In Brief
A Phase 3 clinical trial evaluating Enlicitide Decanoate and Placebo for Hypercholesterolemia and Familial Hypercholesterolemia. Completed, enrolled 303 participants across 59 sites in 17 countries.
Detailed Summary
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial 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--
CountriesAustralia, Brazil, Canada, Chile, Colombia, Czechia, Finland, Hong Kong, Hungary, Israel, Netherlands, New Zealand, Norway, Singapore, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedJul 2023
Enrollment StartAug 2023
Primary CompletionApr 2025
TodayJul 2026
First PostedJul 19, 2023
Enrollment StartAug 8, 2023
Primary CompletionApr 7, 2025
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.0 years ago
Interventions
Enlicitide Decanoatedrug
Oral tablet
Placebodrug
Oral tablet (placebo).