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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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