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Completed

NCT Number: NCT07481708

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

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.

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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

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Enlicitide

Drug

Oral administration

Other names: MK-0616

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Jun 2, 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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