A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)

Korábbi kezelés

• Had a heart failure hospitalization within 3 months before Screening
• Has unstable angina, a myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening
• Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
• Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors

Más betegség

• Has a history of nephrotic syndrome
• Has poorly controlled diabetes mellitus

Életkor

• Is actively receiving chemotherapy for malignancy or has a history of malignancy ≤3 years before Screening

Egyéb

• The main exclusion criteria include but are not limited to the following:
• Has hyperthyroidism or inadequately controlled hypothyroidism

• The main inclusion criteria include but are not limited to the following:
• History of a major atherosclerotic cardiovascular disease (ASCVD) event or if no history of a major ASCVD event, has one or more of the following: possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH), diabetes mellitus, stable angina pectoris, transient ischemic attack or symptomatic peripheral arterial disease
• Has a low-density lipoprotein cholesterol (LDL-C) ≥55 mg/dL or ≥70 mg/dL depending on medical history
• Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
• If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change