Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT06643377Other id0616-032Other idMK-0616-032

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 27 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 22 Nov 2024
Primary completion: 25 Jun 2025
Completion: 25 Jun 2025
First posted: 16 Oct 2024
Last update posted: 20 Oct 2026
Conditions: Healthy · Renal Impairment

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 1
A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)
NCT06643377
22 Nov 2024 to 25 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

EnlicitideDrug

Arms2

Experimental
Panel A: Severe Renal Impairment
Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days.
Experimental
Panel B: Healthy
Healthy participants receive enlicitide QD for 28 days.

Primary outcomes7

Outcomes the sponsor listed as primary.

Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide
Time frame · Day 28 predose and 1, 3, 8, and 24 hours postdose
Registry description
The AUC0-24 of enlicitide in plasma is reported.
Maximum Plasma Concentration (Cmax) of Enlicitide
Time frame · Day 28 predose and 1, 3, 8, and 24 hours postdose
Registry description
The Cmax of enlicitide is reported.
Time to Maximum Plasma Concentration (Tmax) of Enlicitide in Plasma
Time frame · Day 28 predose and 1, 3, 8, and 24 hours postdose
Registry description
The Tmax of plasma enlicitide is reported.
Apparent Plasma Clearance at Steady State (CLss/F) of Enlicitide
Time frame · Day 28 predose and 1, 3, 8, and 24 hours postdose
Registry description
CLss/F of enlicitide is reported.
Apparent Plasma Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide
Time frame · Day 28 predose and 1, 3, 8, and 24 hours postdose
Registry description
The plasma Vz/F of enlicitide was to be reported. Vz/F was not reported, because blood for PK was only collected for 24 hours post dose at steady state (Day 28), thus the terminal phase could not be characterized, and Vz/F could not be calculated.
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame · Up to approximately 42 days
Registry description
The number of participants with ≥1 AE is reported. 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
Time frame · Up to approximately 28 days
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Day 28 predose and 1, 3, 8, and 24 hours postdose

Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide

Group	Value (hr*nmol/L)
Panel A: Severe Renal Impairment Participants	347
Panel B: Healthy Participants	236

Primary outcomeGeometric mean· Day 28 predose and 1, 3, 8, and 24 hours postdose

Maximum Plasma Concentration (Cmax) of Enlicitide

Group	Value (nmol/L)
Panel A: Severe Renal Impairment Participants	17.1
Panel B: Healthy Participants	13.2

Primary outcomeMedian· Day 28 predose and 1, 3, 8, and 24 hours postdose

Time to Maximum Plasma Concentration (Tmax) of Enlicitide in Plasma

Group	Value (Hour)
Panel A: Severe Renal Impairment Participants	5.48
Panel B: Healthy Participants	1.00

Primary outcomeGeometric mean· Day 28 predose and 1, 3, 8, and 24 hours postdose

Apparent Plasma Clearance at Steady State (CLss/F) of Enlicitide

Group	Value (Liters/hour)	Spread
Panel A: Severe Renal Impairment Participants	37.1	25.3
Panel B: Healthy Participants	54.5	20.5

Primary outcome· Day 28 predose and 1, 3, 8, and 24 hours postdose

Apparent Plasma Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide

Group	Value
Panel A: Severe Renal Impairment Participants	not posted
Panel B: Healthy Participants	not posted

Primary outcomeCount of participants· Up to approximately 42 days

Number of Participants Who Experience One or More Adverse Events (AEs)

Group	Value (Participants)
Panel A: Severe Renal Impairment Participants	5
Panel B: Healthy Participants	2

Primary outcomeCount of participants· Up to approximately 28 days

Number of Participants Who Discontinue Study Intervention Due to an AE

Group	Value (Participants)
Panel A: Severe Renal Impairment Participants	3
Panel B: Healthy Participants	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Panel A: Severe Renal Impairment ParticipantsParticipants with severe renal impairment received enlicitide 20 mg QD for 28 days.	0 / 15	3 / 15	4 / 15
Panel B: Healthy ParticipantsHealthy participants received enlicitide 20 mg QD for 28 days.	0 / 12	0 / 12	2 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 85 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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