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.
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part A: Maximum Plasma Concentration (Cmax) of Enlicitide
Timeframe: At designated timepoints (up to 24 hours postdose on day 14)
Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide
Timeframe: At designated timepoints (up to 24 hours postdose on day 14)
Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Timeframe: Baseline and Week 24
Number of Participants Who Experience an Adverse Event (AE)
Timeframe: Up to approximately 188 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Timeframe: Up to approximately 180 weeks