A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Condition(s) studied
Investigational drug(s) / intervention(s)
Enlicitide Decanoate: Oral administration
Placebo: Oral administration
Study 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.
Eligibility
Primary outcome measure(s)
- Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 — Baseline and Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C. - Number of Participants with One or More Adverse Events (AEs) — 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. - Number of Participants who Discontinue Study Drug Due to One or More AEs — 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.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| KLES Prabhakar Kore Hospital & Medical Research Centre [M] ( Site 1004) | Belagavi | Karnataka | Recruiting |
| Sir Ganga Ram Hospital ( Site 1001) | New Delhi | National Capital Territory of Delhi | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07821944 on ClinicalTrials.gov ↗ ← All trials in India