HyperlipidemiaPhase 3NCT07821944
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
A Phase 3 study testing Enlicitide Decanoate in people with Hyperlipidemia and Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia, Hypercholesterolemia
- What is being tested?
- Enlicitide Decanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 15 Oct 2026to 26 Nov 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
KLES Prabhakar Kore Hospital & Medical Research Centre [M] ( Site 1004)
Belagavi, Karnataka, 590010
Study Coordinator, 8312473777
About this study
Official 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
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
- Being tested
- Enlicitide Decanoate, Placebo
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlicitide DecanoateDrug
Also called MK-0616, enlicitide
Oral administration
PlaceboOther
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Enlicitide Decanoate | Experimental | Participants will receive 20 mg enlicitide decanoate orally once daily (qd) for up to 24 weeks. Receives: Drug: Enlicitide Decanoate |
| Placebo | Other | Participants will receive placebo orally qd for up to 24 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start15 Oct 2026
- Primary completion26 Nov 2027 (estimated)
- Study completion26 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821944
- Sponsor's protocol ID
- 0616-038
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf