Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Inclusion Criteria:

• Meets one of the following:

1. Age ≥18 years with a history of a major atherosclerotic cardiovascular disease (ASCVD) event defined as at least 1 of the following: ≥30 days post MI (presumed Type 1 due to plaque rupture or erosion); ≥30 days post ischemicstroke (presumed due to atherosclerosis); or ≥30 days post successfulperipheral (carotid or lower extremity) arterial revascularization (surgical orendovascular) or major (ankle or above) amputation due to atherosclerosis; or

2. High risk for first major ASCVD event defined as at least 1 of the following:Age ≥50 years with evidence of coronary artery disease; Age ≥50 years withevidence of atherosclerotic cerebrovascular disease; Age ≥50 years withevidence of peripheral arterial disease; or Age ≥60 years with diabetesmellitus and at least one of the following: microvascular disease or urinealbumin-creatinine ratio ≥30 mg/mmol within 6 months before Visit 1, dailyinsulin use, or diabetes for ≥10 years

• Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening)as follows:

1. History of major ASCVD Event: LDL-C ≥70 mg/dL (1.81 mmol/L) OR non-HDL-C ≥100mg/dL (2.59 mmol/L)

2. High risk for first major ASCVD Event: LDL-C ≥90 mg/dL (2.33 mmol/L) ORnon-HDL-C ≥120 mg/dL (3.11 mmol/L)

• Is treated with moderate- or high-intensity statin (± nonstatin lipid-loweringtherapy [LLT]) at Visit 1

• Is on a stable dose of all background LLTs (including statin and nonstatin agents)for at least 30 days before Visit 1 (Screening) with no medication or dose changesplanned during the participation in the study

Exclusion Criteria:

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

• Has New York Heart Association Class IV heart failure, last known Left VentricularEjection Fraction ≤25% by any imaging method, or had a Heart Failure hospitalizationwithin 3 months before Visit 1 (Screening)

• Has recurrent ventricular tachycardia within 3 months prior to randomization

• Has a planned arterial revascularization procedure

• Is undergoing or previously underwent an LDL-C apheresis program within 3 monthsbefore Visit 1 (Screening) 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.

• Has a fasting triglyceride value ≥400 mg/dL (≥4.52 mmol/L) at Visit 1 (Screening)