clinical trial · NCT07058077
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Merck Sharp & Dohme LLC·phase3·recruiting·n = 153
Heterozygous Familial Hypercholesterolemia (HeFH)Enlicitide DecanoatePlacebo
brief 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.
started
Aug 21, 2025
primary completion
Dec 4, 2033
completion
Jan 23, 2037
last updated
Jul 2, 2026
official title
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol