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Trial · Interventional

RecruitingPhase 3Registry data

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

NCTNCT07821944 (opens ClinicalTrials.gov in a new tab)Other id0616-038
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
150 participants (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Triple masking
Countries
1 country

India

Start
15 Oct 2026
Primary completion
26 Nov 2027 (estimated)
Completion
26 Nov 2027 (estimated)
First posted
16 Sept 2026
Last update posted
22 Oct 2026
Conditions
Hyperlipidemia · Hypercholesterolemia

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 3

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

    NCT07821944

    15 Oct 2026 to est. 26 Nov 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Enlicitide DecanoateDrug
  • PlaceboOther

Arms2

  • Experimental

    Enlicitide Decanoate

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

  • Other

    Placebo

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

Primary outcomes3

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline and Week 24

    Registry description

    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

    Registry description

    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

    Registry description

    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(5)

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

    Time frame · Baseline and Week 24

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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