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

Inclusion Criteria:

Inclusion criteria include, but are not limited to:

• Has possible or definite diagnosis of HeFH based on a locally accepted diagnosticalgorithm or diagnosis by genetic testing results

• Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL

• Is receiving either:

• An optimized daily dose of statin (± nonstatin LLT)

• A nonstatin LLT with documented intolerance to at least 2 different statins, ordocumented intolerance to 1 statin plus refusal of statin therapy by theparticipant or legally acceptable representative

• Is on a stable dose of all background LLTs for at least 30 days prior to screening,with no medication or dose changes planned during participation in Part A or Part B

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

• Has a history of homozygous FH based on genetic or clinical criteria, or history ofknown compound heterozygous FH, or double heterozygous FH

• Has a history of nephrotic syndrome

• Has any clinically significant malabsorption condition based on investigatorassessment

• Was previously treated/is being treated with certain other cholesterol loweringmedications, including proprotein convertase subtilisin/kexin type 9 (PCSK9)inhibitors without adequate washout