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

July 21, 2025 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panel A: Severe Renal Impairment
Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days.
Drug: Enlicitide
Oral tablet
Other Names:
  • MK-0616
  • Enlicitide decanoate
Experimental: Panel B: Healthy
Healthy participants receive enlicitide QD for 28 days.
Drug: Enlicitide
Oral tablet
Other Names:
  • MK-0616
  • Enlicitide decanoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma
Time Frame: 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.
Pre-dose and at designated time points up to 24 hours post dose on Day 28
Maximum plasma concentration (Cmax) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 24 hours post dose on Day 28
Cmax of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 24 hours post dose on Day 28
Time to maximum plasma concentration (Tmax) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 24 hours post dose on Day 28
Tmax of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 24 hours post dose on Day 28
Apparent Clearance (CL/F) of enlicitide in plasma
Time Frame: 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.
Pre-dose and at designated time points up to 24 hours post dose on Day 28
Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma
Time Frame: 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.
Pre-dose and at designated time points up to 24 hours post dose on Day 28
Number of participants who experience one or more adverse events (AEs)
Time Frame: 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.
Up to approximately 42 days
Number of participants who discontinue study intervention due to an AE
Time Frame: 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.
Up to approximately 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2024

Primary Completion (Actual)

June 25, 2025

Study Completion (Actual)

June 25, 2025

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0616-032
  • MK-0616-032 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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