NCT07058077

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

An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions

Type	Name	Description
DRUG	Enlicitide Decanoate	Enlicitide decanoate taken by mouth
DRUG	Placebo	Placebo tablet matched to enlicitide decanoate taken by mouth

Timeline

• Start date: 2025-08-21
• Primary completion: 2033-12-04
• Completion: 2037-01-23
• First posted: 2025-07-10
• Last updated: 2026-04-13

Locations

23 sites across 12 countries: United States, Australia, Belgium, Brazil, China, Colombia, Finland, Netherlands, New Zealand, Singapore, Spain, United Kingdom

Regulatory

• FDA-regulated drug study