A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
Phase 3 – large-scale trial before approval
Conditions:
Hyperlipidemia
Sponsor: Merck Sharp & Dohme LLC
trial.available_in:
БГ
Overview
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.
Who can participate
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 underwent an LDL-C apheresis program within 3 months before Screening or plans to initiate an LDL-C apheresis program.
* Has received any medication that may interact with rosuvastatin within 5 half-lives prior to Screening or is planning to initiate such treatment.
БГ