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Active, Not Recruiting

NCT Number: NCT07216482

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEMEDIC ( Site 0201), CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enlicitide

Drug

Oral Tablet

Other names: MK-0616, Enlicitide decanoate

Rosuvastatin

Drug

Oral Capsule

Placebo for enlicitide

Drug

Oral Tablet

Placebo for Rosuvastatin

Drug

Oral Capsule

Primary outcomes

  1. Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C between participants treated with enlicitide and rosuvastatin versus placebo.

Secondary outcomes

  1. Mean Percent Change from Baseline in LDL-C at Week 8

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C.

  2. Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess mean percent change in ApoB.

  3. Number of Participants with One or More Adverse Events (AEs)

    Time frame: Up to approximately 20 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  4. Number of Participants who Discontinue Study Drug Due to One or More AEs

    Time frame: Up to approximately 12 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  5. Mean Percent Change from Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

    Blood samples will be collected at baseline and at Week 12 to assess mean percent change in LDL-C.

  6. Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess mean percent change in non-HDL-C.

  7. Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess percent change in Lp(a).

  8. Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.

  9. Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 14, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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