A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)

An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06643377

Enrollment

Registered

2024-10-16

Start date

2024-11-22

Completion date

2025-06-25

Last updated

2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Renal Impairment

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.

Interventions

DRUGEnlicitide

Oral tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026