Testing a new medication for lowering cholesterol in people with severe kidney issues
An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment
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 |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 5 sites (Edgewater, Florida and 4 other locations) |
| Trial ID | NCT06643377 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with severe renal impairment and a stable dose of statin therapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Edgewater, Florida and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.