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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypercholesterolemia; Hyperlipidemia
• Intervention / Treatment: Other: Placebo; Drug: Enlicitide Decanoate

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enlicitide Decanoate; Participants will receive 20 mg enlicitide decanoate orally once daily (qd) for up to 24 weeks.	Drug: Enlicitide Decanoate; Oral administration; Other Names: MK-0616; enlicitide
Other: Placebo; Participants will receive placebo orally qd for up to 24 weeks.	Other: Placebo; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change From Baseline in Non High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24	Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.	Baseline and Week 24
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24	Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.	Baseline and Week 24
Percent Change From Baseline in Lipoprotein (a) (Lp(a)) at Week 24	Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a)	Baseline and Week 24
Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at 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.	Baseline and Week 24
Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at 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.	Baseline and Week 24

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Estimated): October 16, 2026
• Primary Completion (Estimated): November 26, 2027
• Study Completion (Estimated): November 26, 2027

Study Registration Dates

• First Submitted: September 9, 2026
• First Submitted That Met QC Criteria: September 9, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypercholesterolemia; Hyperlipidemias; MK-0616
• Other Study ID Numbers: 0616-038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes