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A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)

NCT07216482

Active Not RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Hyperlipidemia

Interventions: Enlicitide, Rosuvastatin, Placebo for Enlicitide, Placebo for Rosuvastatin

Countries: United States, Argentina, Australia, Brazil, Canada, Hungary, Israel, New Zealand

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 overview

Sex: ALL

Age: 18 Years to 64 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.
Locations (89)
  • Birmingham, Alabama, United States
  • Foley, Alabama, United States
  • Phoenix, Arizona, United States
  • Tempe, Arizona, United States
  • Lancaster, California, United States
  • Sacramento, California, United States
  • Colorado Springs, Colorado, United States
  • Fort Myers, Florida, United States
  • Hollywood, Florida, United States
  • Lake City, Florida, United States
  • Miami Lakes, Florida, United States
  • Tampa, Florida, United States
  • Winter Park, Florida, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Newton, Kansas, United States
  • Topeka, Kansas, United States
  • Louisville, Kentucky, United States
  • Las Vegas, Nevada, United States
  • Elmer, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Norman, Oklahoma, United States
  • Yardley, Pennsylvania, United States
  • Houston, Texas, United States
  • Odessa, Texas, United States
  • Pearland, Texas, United States
  • San Antonio, Texas, United States
  • San Antonio, Texas, United States
  • Tomball, Texas, United States
  • + 59 more on CT.gov