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

NCT07821944 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 0616-038
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hyperlipidemia; Hypercholesterolemia

Outcome Measures

Primary Outcomes (3)

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

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

  Baseline and Week 24

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

  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.

  Up to approximately 32 Weeks

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

  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.

  Up to approximately 24 Weeks

Secondary Outcomes (5)

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

  Baseline and Week 24

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

  Baseline and Week 24

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

  Baseline and Week 24

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

  Baseline and Week 24

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

  Baseline and Week 24

Study Arms (2)

Enlicitide Decanoate

EXPERIMENTAL

Participants will receive 20 mg enlicitide decanoate orally once daily (qd) for up to 24 weeks.

Drug: Enlicitide Decanoate

Placebo

OTHER

Participants will receive placebo orally qd for up to 24 weeks.

Other: Placebo

Interventions

Enlicitide Decanoate DRUG

Oral administration

Also known as: MK-0616, enlicitide

Enlicitide Decanoate

Placebo OTHER

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hyperlipidemias; Hypercholesterolemia

Interventions

MK-0616

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): October 16, 2026
• Primary Completion (Estimated): November 26, 2027
• Study Completion (Estimated): November 26, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share