Clinical Trial

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Recruiting Phase 2/3
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Summary
This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood. The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.
Protocol Amendment History 3 changes
notable Trial sites expanded: 33 -> 36 locations 2026-07-25
notable Trial sites expanded: 30 -> 33 locations 2026-07-03
notable Trial sites expanded: 26 -> 29 locations 2026-05-23
Trial Details
NCT Number NCT07058077
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Heterozygous Familial Hypercholesterolemia (HeFH)
Enrollment 153 participants
Start Date 2025-08-21
Primary Completion 2033-12-04 (estimated)
Study Completion 2037-01-23 (estimated)
Updated on ClinicalTrials.gov 2026-08-10