HealthyPhase 1NCT06643377

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

A Phase 1 study testing Enlicitide in people with Healthy and Renal Impairment, run by Merck Sharp & Dohme LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Renal Impairment
What is being tested?: Enlicitide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 5 sitesUnited States
Study dates: 22 Nov 2024to 25 Jun 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Velocity Clinical Research, New Smyrna Beach ( Site 0003)
Edgewater, Florida, 32132
Velocity Clinical Research, Hallandale Beach ( Site 0006)
Hallandale, Florida, 33009
Nature Coast Clinical Research - Inverness ( Site 0002)
Inverness, Florida, 34452
Jacksonville Center for Clinical Research ( Site 0004)
Jacksonville, Florida, 32216
Genesis Clinical Research, LLC ( Site 0001)
Tampa, Florida, 33603

Other trials in United States

About this study

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

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.

Conditions: Healthy, Renal Impairment
Being tested: Enlicitide
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EnlicitideDrug
Also called Enlicitide decanoate, MK-0616
Oral tablet

Study groups in NCT06643377
Study group	Role	What they receive
Panel A: Severe Renal Impairment	Experimental	Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days. Receives: Drug: Enlicitide
Panel B: Healthy	Experimental	Healthy participants receive enlicitide QD for 28 days. Receives: Drug: Enlicitide

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide
The AUC0-24 of enlicitide in plasma is reported.
Measured: Day 28 predose and 1, 3, 8, and 24 hours postdose
Maximum Plasma Concentration (Cmax) of Enlicitide
The Cmax of enlicitide is reported.
Measured: Day 28 predose and 1, 3, 8, and 24 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Enlicitide in Plasma
The Tmax of plasma enlicitide is reported.
Measured: Day 28 predose and 1, 3, 8, and 24 hours postdose
Apparent Plasma Clearance at Steady State (CLss/F) of Enlicitide
CLss/F of enlicitide is reported.
Measured: Day 28 predose and 1, 3, 8, and 24 hours postdose
Apparent Plasma Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide
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.
Measured: Day 28 predose and 1, 3, 8, and 24 hours postdose
Number of Participants Who Experience One or More Adverse Events (AEs)
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.
Measured: Up to approximately 42 days
Number of Participants Who Discontinue Study Intervention Due to an AE
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.
Measured: Up to approximately 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 202425 Jun 2025

First posted16 Oct 2024
Study start22 Nov 2024
Primary completion25 Jun 2025
Study completion25 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06643377
Sponsor's protocol ID: 0616-032
Other IDs: MK-0616-032
Status last verified: Jul 2026
First submitted: 14 Oct 2024
Last updated: 20 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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