A Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041)

June 1, 2026 updated by: Merck Sharp & Dohme LLC

A Clinical Study to Evaluate the Relative Bioavailability of Enlicitide Tablet Formulations Compared to the Reference Formulation in Healthy Adult Participants

The goal of this study is to learn what happens to enlicitide (MK-0616) in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of enlicitide and if people tolerate it.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion ( 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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

  • Is in good health
  • Has a body-mass index (BMI) between 18 and 32 kg/m^2

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

  • Has a history of clinically significant gastrointestinal disease that may impact drug absorption
  • Has a history of cancer (malignancy)

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose regimen A
Participants receive enlicitide orally at dose regimen A.
Drug: Enlicitide
Oral administration
Other Names:
  • MK-0616
Experimental: Dose regimen B
Participants receive enlicitide orally at dose regimen B.
Drug: Enlicitide
Oral administration
Other Names:
  • MK-0616
Active Comparator: Dose regimen C
Participants receive enlicitide orally at dose regimen C.
Drug: Enlicitide
Oral administration
Other Names:
  • MK-0616

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide
Time Frame: At designated timepoints up to approximately 50 days
Blood samples will be collected to determine the AUC0-Last of enlicitide.
At designated timepoints up to approximately 50 days
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide
Time Frame: At designated timepoints up to approximately 50 days
Blood samples will be collected to determine the AUC0-Inf of enlicitide.
At designated timepoints up to approximately 50 days
Maximum Plasma Concentration (Cmax) of enlicitide
Time Frame: At designated timepoints up to approximately 50 days
Blood samples will be collected to estimate Cmax of enlicitide.
At designated timepoints up to approximately 50 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 56 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 56 days
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 56 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 56 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)

March 23, 2026

Primary Completion (Actual)

May 18, 2026

Study Completion (Actual)

May 25, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0616-041
  • MK-0616-041 (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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