Do you have elevated low-density lipoprotein cholesterol (LDL-C) levels? Are you having trouble managing this important biomarker?
Researchers have designed an experimental 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.
Would you like to take part? Would you like a friend or family member to take part?
As a volunteer in a research study, you will receive personal study-related medical care from the study doctor and regular follow up on your health to monitor the effectiveness of the care you will receive. The results of this research will be used to find out if the experimental medication being studied will be of benefit to others with elevated lipoprotein levels or not. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Have either not received lipid-lowering therapy (LLT) or have not received certain LLTs within a specified time period prior to the study.
- Are between the ages of 18 and 64 (inclusive)
You may not qualify to participate in this study if you:
- Have a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.
- Have experienced a heart failure hospitalization within 3 months before Screening.
- Are unwilling to take a statin, and/or have a history of statin-associated muscle symptoms or other statin-related AEs to any statin and dose, and/or are known to be intolerant to 1 or more statins.
- Have 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) Have a personal or family history of hereditary muscular disorders.
- Have active or chronic hepatobiliary or hepatic disease.
- Have a known human immunodeficiency virus (HIV) infection.
- Are undergoing or previously underwent an LDL-C apheresis program within 3 months before Screening or plan to initiate an LDL-C apheresis program.
- Have received any medication that may interact with rosuvastatin within 5 half-lives prior to Screening or are planning to initiate such treatment
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
Participants who qualify for this study will receive a study-related health examination at no cost, as well as possible compensation for time and travel.
