NCT07619443

Brief Summary

The goal of this study is to learn what happens to a single dose of enlicitide over time in a healthy participant's body when the participant is given a single dose of MK-7262 and what happens to a single dose of MK-7262 over time in a healthy participant's body when the participant is given a single dose of enlicitide.

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 Jul 2026

Shorter than P25 for phase_1 healthy

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 6, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2026

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2026

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 27, 2026

Last Update Submit

May 27, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-7262

    Blood samples will be collected at multiple time points to estimate the AUC0-inf of MK-7262.

    Predose and at designated time points post-dose (up to 8 days)

  • AUC0-inf of Enlicitide

    Blood samples will be collected at multiple time points to estimate the AUC0-inf of enlicitide.

    Predose and at designated time points post-dose (up to 8 days post-dose)

  • Maximum Plasma Concentration (Cmax) of MK-7262

    Blood samples will be collected at multiple time points to estimate the steady-state Cmax of MK-7262.

    Predose and at designated time points post-dose (up to 8 days post-dose)

  • Cmax of Enlicitide

    Blood samples will be collected at multiple time points to estimate the steady-state Cmax of enlicitide.

    Predose and at designated time points post-dose (up to 8 days post-dose)

Secondary Outcomes (14)

  • Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of MK-7262

    Predose and at designated time points post-dose (up to 24 hours post-dose)

  • Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-7262

    Predose and at designated time points post-dose (up to 8 days post-dose)

  • Time to Maximum Plasma Concentration (Tmax) of MK-7262

    Predose and at designated time points post-dose (up to 8 days post-dose)

  • Apparent Terminal Half-life (t1/2) of MK-7262

    Predose and at designated time points post-dose (up to 8 days post-dose)

  • Apparent Clearance (CL/F) of MK-7262

    Predose and at designated time points post-dose (up to 8 days post-dose)

  • +9 more secondary outcomes

Study Arms (3)

MK-7262

EXPERIMENTAL

Participants will receive MK-7262 orally.

Drug: MK-7262

Enlicitide

EXPERIMENTAL

Participants will receive enlicitide orally.

Drug: Enlicitide

MK-7262 plus Enlicitide

EXPERIMENTAL

Participants will receive MK-7262 and enlicitide orally.

Drug: MK-7262Drug: Enlicitide

Interventions

Oral administration

MK-7262MK-7262 plus Enlicitide

Oral administration

Also known as: enlicitide decanoate, MK-0616
EnlicitideMK-7262 plus Enlicitide

Eligibility Criteria

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

You may qualify if:

  • Is in good health before randomization
  • Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

You may not qualify if:

  • Has a history or presence of clinically significant medical or psychiatric condition or disease
  • Has a history of cancer

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

May 27, 2026

First Posted

June 2, 2026

Study Start (Estimated)

July 6, 2026

Primary Completion (Estimated)

September 5, 2026

Study Completion (Estimated)

September 12, 2026

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

More information