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

Exploring a new cholesterol treatment for young patients with high cholesterol.

Recruiting
6-17 years
All
Phase 2/3

This study checks if a medication called enlicitide decanoate can safely and effectively lower bad cholesterol in kids with heterozygous familial hypercholesterolemia (HeFH). HeFH is a condition where cholesterol levels are too high. The medicine enlicitide stops a protein called PCSK9, which helps lower cholesterol levels in the blood. The study also wants to know how enlicitide works in a child's body over time compared to a placebo, which is a fake treatment with no medicine.

To join the study, kids must have a certain level of bad cholesterol and already be taking cholesterol-lowering treatments like statins. Some kids can't join if they have other serious health problems or have taken certain other cholesterol medicines recently.

  • The study involves taking a new medication and comparing it to a placebo.
  • Participants should be on a stable cholesterol-lowering treatment before joining.
  • Children with certain medical conditions are not eligible.
Study details
    Heterozygous Familial Hypercholesterolemia (HeFH)

NCT07058077

Merck Sharp & Dohme LLC

17 October 2026

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