A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
Trial Parameters
Brief Summary
Researchers designed a study medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C). In this study, researchers want to learn about giving enlicitide with another medicine called rosuvastatin. Rosuvastatin is a standard (usual) treatment to lower LDL-C. The goal of this study is to learn if enlicitide given with rosuvastatin works better than placebo on lowering LDL-C in a person's blood. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine.
Eligibility Criteria
Inclusion Criteria: -Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study. Exclusion Criteria: * Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH. * Had a heart failure hospitalization within 3 months before Screening. * Is unwilling to take a statin, and/or has a history of statin-associated muscle symptoms or other statin-related AEs to any statin and dose, and/or is known to be intolerant to 1 or more statins. * Has a history of any of the following conditions: (1) Myopathy, myositis, rhabdomyolysis, or unexplained muscle pain; (2) Muscular or neuromuscular disease; (3) Neuropathy, fibromyalgia, or chronic pain; or (4) Has a personal or family history of hereditary muscular disorders. * Has active or chronic hepatobiliary or hepatic disease. * Has known human immunodeficiency virus (HIV) infection. * Is undergoing or previously underwe