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NCT Number: NCT06880874

A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)

The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

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:

  • Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
  • Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2

Exclusion criteria

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

  • Has history of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
  • Has history of cancer (malignancy)
  • Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Treatment and study plan

Enlicitide

Drug

Oral Tablet

Other names: MK-0616, enlicitide decanoate

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of enlicitide in plasma

    Time frame: Pre-dose and at designated time points up to 24 hours post dose

    Blood samples will be collected to determine the AUC0-24hr of enlicitide.

  2. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide in plasma

    Time frame: Pre-dose and at designated time points up to 168 hours post dose

    Blood samples will be collected to determine the AUC0-Last of enlicitide.

  3. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide in plasma

    Time frame: Pre-dose and at designated time points up to 168 hours post dose

    Blood samples will be collected to determine the AUC0-Inf of enlicitide.

  4. Maximum Plasma Concentration (Cmax) of enlicitide in plasma

    Time frame: Pre-dose and at designated time points up to 168 hours post dose

    Blood samples will be collected to determine the Cmax of enlicitide.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 14 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. The number of participants who experience an AE will be reported.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 8 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. The number of participants who discontinue study treatment due to an AE will be reported.

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 Formulations in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Jun 15, 2025

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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