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NCT Number: NCT07619443

A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003)

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.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Lincoln, Nebraska, 68502, United States

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

402-476-2811

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

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

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

Treatment and study plan

MK-7262

Drug

Oral administration

Enlicitide

Drug

Oral administration

Other names: enlicitide decanoate, MK-0616

Primary outcomes

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

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

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

  2. AUC0-inf of Enlicitide

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

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

  3. Maximum Plasma Concentration (Cmax) of MK-7262

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

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

  4. Cmax of Enlicitide

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

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

Secondary outcomes

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

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

    Blood samples will be collected at multiple time points to estimate the AUC0-24 of MK-7262.

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

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

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

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

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

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

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

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

    Blood samples will be collected at multiple time points to estimate the t1/2 of MK-7262.

  5. Apparent Clearance (CL/F) of MK-7262

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

    Blood samples will be collected at multiple time points to estimate the CL/F of MK-7262.

  6. Apparent Volume of Distribution During Terminal Phase (Vz/F)of MK-7262

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

    Blood samples will be collected at multiple time points to estimate the Vz/F of MK-7262.

  7. AUC0-24 of Enlicitide

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

    Blood samples will be collected at multiple time points to estimate the AUC0-24 of enlicitide.

  8. AUC0-last of Enlicitide

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

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

  9. Tmax of Enlicitide

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

    Blood samples will be collected at multiple time points to estimate the Tmax of enlicitide.

  10. t1/2 of Enlicitide

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

    Blood samples will be collected at multiple time points to estimate the t1/2 of enlicitide.

  11. CL/F of Enlicitide

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

    Blood samples will be collected at multiple time points to estimate the CL/F of enlicitide.

  12. Vz/F of Enlicitide

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

    Blood samples will be collected at multiple time points to estimate the Vz/F of enlicitide.

  13. Number of Participants Who Experience One or More Adverse Events (AEs)

    Time frame: Up to approximately 8 weeks

    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. The number of participants that experience AEs will be reported.

  14. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 6 weeks

    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. The number of participants that discontinue study intervention due to an AE will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Clinical Drug-Drug Interaction Study to Evaluate the Mutual Pharmacokinetic Effects of MK-7262 and Enlicitide in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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