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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts 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 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Enlicitide 		Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
  • Drug: Enlicitide
    Oral Tablet
    Other names:
    • MK-0616
    • Enlicitide decanoate
  • Drug: Placebo for Rosuvastatin
    Oral Capsule
Experimental
Enlicitide + Rosuvastatin 		Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
  • Drug: Enlicitide
    Oral Tablet
    Other names:
    • MK-0616
    • Enlicitide decanoate
  • Drug: Rosuvastatin
    Oral Capsule
Active Comparator
Rosuvastatin 		Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
  • Drug: Rosuvastatin
    Oral Capsule
  • Drug: Placebo for Enlicitide
    Oral Tablet
Placebo Comparator
Placebo 		Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.
  • Drug: Placebo for Enlicitide
    Oral Tablet
  • Drug: Placebo for Rosuvastatin
    Oral Capsule

Recruiting Locations

Central Research Associates ( Site 0009)
Birmingham, Alabama 35205
Contact:
Study Coordinator
205-327-1077

G&L Research ( Site 0024)
Foley, Alabama 36535
Contact:
Study Coordinator
251-943-2980

Chemidox Clinical Trials ( Site 0008)
Lancaster, California 93534
Contact:
Study Coordinator
833-324-3643

Clinical Trials Research ( Site 0036)
Sacramento, California 95821
Contact:
Study Coordinator
916-487-8230

Legacy Clinical Trials ( Site 0044)
Colorado Springs, Colorado 80909
Contact:
Study Coordinator
719-387-7572

Soffer Health Institute ( Site 0046)
Hollywood, Florida 33020
Contact:
Study Coordinator
305-792-0555

Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
Winter Park, Florida 32789
Contact:
Study Coordinator
407-740-8078

Monroe Biomedical Research ( Site 0004)
Louisville, Kentucky 40213
Contact:
Study Coordinator
502-515-5672

Jubilee Clinical Research ( Site 0031)
Las Vegas, Nevada 89106
Contact:
Study Coordinator
702-631-5000

Provecta Research Network LLC ( Site 0022)
Houston, Texas 77027
Contact:
Study Coordinator
346-735-8990

Clinical Trials of Texas, Inc. ( Site 0010)
San Antonio, Texas 78229
Contact:
Study Coordinator
210-949-0122

National Clinical Research, Inc ( Site 0028)
Richmond, Virginia 23294
Contact:
Study Coordinator
804-755-2300

More Details

NCT ID
NCT07216482
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center