A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

Inclusion Criteria:

• Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event andLDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to highrisk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.

• Is treated with a moderate- or high-intensity statin OR is treated withlow-intensity statin with documentation of intolerance to a moderate orhigh-intensity statin OR is not receiving statins with documentation of statinintolerance

• If on any lipid-lowering therapies (LLTs), should be on a stable dose with noplanned medication change.

Exclusion Criteria:

• Has a history of homozygous familial hypercholesterolemia (FH) based on genetic orclinical criteria, compound heterozygous FH, or double heterozygous FH

• Has a history of heart failure or heart failure hospitalization within 3 monthsbefore first study visit

• Is undergoing or previously underwent an LDL-C apheresis program within 3 monthsbefore first study visit or plans to initiate an LDL-C apheresis program

• Was previously treated/is being treated with certain other cholesterol loweringmedications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitorswithout adequate washout