A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)
- Registration Number
- NCT06643377
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel A: Severe Renal Impairment Enlicitide Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days. Panel B: Healthy Enlicitide Healthy participants receive enlicitide QD for 28 days.
- Primary Outcome Measures
Name Time Method Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma Pre-dose and at designated time points up to 24 hours post dose on Day 28 AUC0-24 of enlicitide in plasma will be determined.
Maximum plasma concentration (Cmax) of enlicitide in plasma Pre-dose and at designated time points up to 24 hours post dose on Day 28 Cmax of enlicitide in plasma will be determined.
Time to maximum plasma concentration (Tmax) of enlicitide in plasma Pre-dose and at designated time points up to 24 hours post dose on Day 28 Tmax of enlicitide in plasma will be determined.
Apparent Clearance (CL/F) of enlicitide in plasma Pre-dose and at designated time points up to 24 hours post dose on Day 28 CL/F of enlicitide in plasma will be determined.
Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma Pre-dose and at designated time points up to 24 hours post dose on Day 28 Vz/F of enlicitide in plasma will be determined.
Number of participants who experience one or more adverse events (AEs) Up to approximately 42 days 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 intervention due to an AE Up to approximately 28 days 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Nature Coast Clinical Research - Inverness ( Site 0002)
🇺🇸Inverness, Florida, United States
Genesis Clinical Research, LLC ( Site 0001)
🇺🇸Tampa, Florida, United States
Velocity Clinical Research, Hallandale Beach ( Site 0006)
🇺🇸Hallandale Beach, Florida, United States
Jacksonville Center for Clinical Research ( Site 0004)
🇺🇸Jacksonville, Florida, United States
Velocity Clinical Research, New Smyrna Beach ( Site 0003)
🇺🇸Edgewater, Florida, United States