Testing a new medication for lowering cholesterol in people with severe kidney issues
Official title: An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment
Run by Merck Sharp & Dohme LLC · NCT06643377 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new medication to see if it can lower cholesterol levels in people with severe kidney problems compared to healthy individuals.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 5 sites (Edgewater, Florida and 4 other locations) |
| Trial ID | NCT06643377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with severe renal impairment and a stable dose of statin therapy.
✕Probably not a fit
Patients with a history of renal artery stenosis or those who have had a functioning renal transplant in the past 5 years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study investigates the pharmacokinetics of enlicitide, a new medication designed to reduce low-density lipoprotein cholesterol (LDL-C) levels, in individuals with severe renal impairment compared to healthy participants. The study aims to understand how the body processes enlicitide over a 24-hour period in both groups. Participants will be monitored for the total amount of enlicitide in their system to determine if there are significant differences between those with kidney issues and healthy individuals. The study is interventional and is classified as Phase 1, focusing on safety and dosage.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with severe renal impairment who need to manage high cholesterol levels.
How similar studies have gone: While this approach is novel in the context of severe renal impairment, similar studies have shown promise in understanding pharmacokinetics of medications in different populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Body Mass Index (BMI) between 18 and 40 kg/m\^2, inclusive * On a stable dose of statin therapy; no changes to dose or type of statin therapy for at least 2 months Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * History or presence of renal artery stenosis * Had a functioning renal transplant in the past 5 years and is taking transplant medication * History of gastrointestinal (GI) disease which might affect food and drug absorption Panel A: Participants with Severe Renal Impairment: - History of any illness, other than hypercholesterolemia and Renal Impairment Panel B: Healthy Participants: - History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases, other than hypercholesterolemia
Where it's running
-
Velocity Clinical Research, New Smyrna Beach ( Site 0003)
Edgewater, Florida, United States Recruiting -
Velocity Clinical Research, Hallandale Beach ( Site 0006)
Hallandale Beach, Florida, United States Recruiting -
Nature Coast Clinical Research - Inverness ( Site 0002)
Inverness, Florida, United States Recruiting -
Jacksonville Center for Clinical Research ( Site 0004)
Jacksonville, Florida, United States Recruiting -
Genesis Clinical Research, LLC ( Site 0001)
Tampa, Florida, United States Recruiting
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.