drugset / Trial / NCT07058077

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

NCT07058077

Phase 2/3 Recruiting 153 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-08-21
Primary completion
2033-12-04
Completion
2037-01-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Enlicitide Decanoate Unknown Oral