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NCT Number: NCT07821944

A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)

Researchers are looking for new ways to treat high cholesterol. Cholesterol is a type of fat in the blood.

Enlicitide (also known as enlicitide decanoate or MK-0616), the study medicine, is in a class of medicines designed to lower low-density lipoprotein cholesterol (LDL-C). LDL-C is sometimes called "bad cholesterol."

The goal of this study is to learn if enlicitide works better than placebo to lower the amount of LDL-C in a person's blood. Researchers also want to learn about the safety of enlicitide and if people tolerate it.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • History of a major atherosclerotic cardiovascular disease (ASCVD) event or if no history of a major ASCVD event, has one or more of the following: possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH), diabetes mellitus, stable angina pectoris, transient ischemic attack or symptomatic peripheral arterial disease
  • Has a low-density lipoprotein cholesterol (LDL-C) ≥55 mg/dL or ≥70 mg/dL depending on medical history
  • Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
  • If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Had a heart failure hospitalization within 3 months before Screening
  • Has unstable angina, a myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening
  • Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
  • Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
  • Has a history of nephrotic syndrome
  • Has poorly controlled diabetes mellitus
  • Has hyperthyroidism or inadequately controlled hypothyroidism
  • Is actively receiving chemotherapy for malignancy or has a history of malignancy ≤3 years before Screening

Treatment and study plan

Enlicitide Decanoate

Drug

Oral administration

Other names: MK-0616, enlicitide

Placebo

Other

Oral administration

Primary outcomes

  1. Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

    Time frame: Baseline and Week 24

    Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.

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

    Time frame: Up to approximately 32 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.

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

    Time frame: Up to approximately 24 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.

Secondary outcomes

  1. Mean Percent Change From Baseline in Non High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24

    Time frame: Baseline and Week 24

    Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.

  2. Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24

    Time frame: Baseline and Week 24

    Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.

  3. Percent Change From Baseline in Lipoprotein (a) (Lp(a)) at Week 24

    Time frame: Baseline and Week 24

    Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a)

  4. Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24

    Time frame: Baseline and Week 24

    Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.

  5. Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24

    Time frame: Baseline and Week 24

    Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate in Adults With Hyperlipidemia in India

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 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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