NCT07481708

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
2mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

March 16, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Expected
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 16, 2026

Last Update Submit

March 16, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide

    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

    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

    Blood samples will be collected to estimate Cmax of enlicitide.

    At designated timepoints up to approximately 50 days

Secondary Outcomes (2)

  • Number of Participants Who Experience an Adverse Event (AE)

    Up to approximately 56 days

  • Number of Participants Who Discontinue Study Intervention Due to an AE

    Up to approximately 56 days

Study Arms (3)

Dose regimen A

EXPERIMENTAL

Participants receive enlicitide orally at dose regimen A.

Drug: Enlicitide

Dose regimen B

EXPERIMENTAL

Participants receive enlicitide orally at dose regimen B.

Drug: Enlicitide

Dose regimen C

ACTIVE COMPARATOR

Participants receive enlicitide orally at dose regimen C.

Drug: Enlicitide

Interventions

EnlicitideDRUG

Oral administration

Also known as: MK-0616
Dose regimen ADose regimen BDose regimen C

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

MK-0616

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 19, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

More information