A Phase 23 Study to Evaluate the Safety and Effectiveness of Enlicitide Decanoate for Children and Adolescents With Heterozygous Familial Hypercholesterolemia

What this Trial Is About

Researchers are studying whether enlicitide decanoate is safe and effective for treating children and adolescents aged 6 to 17 years with heterozygous familial hypercholesterolemia HeFH, a condition causing high levels of LDL cholesterol in the blood. The study aims to understand how enlicitide behaves in the body over time, how well children tolerate it, and whether it lowers cholesterol better than a placebo. Participants receive enlicitide decanoate orally once daily at doses based on their age. The study includes a short initial treatment of up to 2 weeks, followed by a longer treatment of up to 24 weeks comparing enlicitide to placebo. Those who complete the initial parts may join an open-label extension receiving enlicitide for up to 3 years. During the study, participants undergo blood tests to measure cholesterol levels and the amount of drug in their blood at designated times. Researchers monitor safety by tracking side effects and whether participants discontinue treatment due to adverse events, with follow-up lasting up to about 188 weeks. The study assesses changes in LDL cholesterol and other blood lipids, as well as carotid artery thickness, to evaluate effects over time.

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