Clinical trial NCT06643377: A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)
Official title: An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Renal Impairment
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 24 hours post dose on Day 28
measure: Maximum plasma concentration (Cmax) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 24 hours post dose on Day 28
measure: Time to maximum plasma concentration (Tmax) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 24 hours post dose on Day 28
measure: Apparent Clearance (CL/F) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 24 hours post dose on Day 28
measure: Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 24 hours post dose on Day 28
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to approximately 42 days
measure: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to approximately 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Edgewater
country: United States
facility: Velocity Clinical Research, New Smyrna Beach ( Site 0003)
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0006)
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research - Inverness ( Site 0002)
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research ( Site 0004)
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC ( Site 0001)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: