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.
Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results
Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL
An optimized daily dose of statin (± nonstatin LLT)
A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of statin therapy by the participant or legally acceptable representative
Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH
Has a history of nephrotic syndrome
Has any clinically significant malabsorption condition based on investigator assessment
Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
Parallel
Enlicitide Decanoate
DrugEnlicitide decanoate taken by mouth
Placebo
DrugPlacebo tablet matched to enlicitide decanoate taken by mouth
Part A: Maximum Plasma Concentration (Cmax) of Enlicitide
Blood samples will be collected to determine the Cmax of enlicitide.
Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide
Blood samples will be collected to determine the AUC0-24 of enlicitide.
Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Blood samples will be collected to determine the percent change from baseline in LDL-C.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Part B: Percent Change from Baseline in Apolipoprotein B (ApoB)
Blood samples will be collected to determine the percent change from baseline in apolipoprotein B.
Part B: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Blood samples will be collected to determine the percent change from baseline in non-HDL-C.
Part B: Percent Change from Baseline in Lipoprotein (a) (Lp(a))
Blood samples will be collected to determine the percent change from baseline in Lp(a).
Part B: Percentage of Participants With LDL-C <130 mg/dL at Week 24
The percentage of participants with LDL-C \<130 mg/dL at week 24 will be reported.
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