A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia
Merck Sharp & Dohme LLC
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
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugEnlicitide
Oral Tablet
- DrugRosuvastatin
Oral Capsule
- DrugPlacebo for Enlicitide
Oral Tablet
- DrugPlacebo for Rosuvastatin
Oral Capsule
Locations (89)
- Central Research Associates ( Site 0009)Birmingham, Alabama
- G&L Research ( Site 0024)Foley, Alabama
- Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)Phoenix, Arizona
- Alliance for Multispecialty Research LLC ( Site 0049)Tempe, Arizona
- Chemidox Clinical Trials ( Site 0008)Lancaster, California
- Clinical Trials Research ( Site 0036)Sacramento, California