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NCT Number: NCT07776665

A Clinical Trial of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-044)

The goal of this trial is to learn what happens to different formulations (types) of enlicitide in a healthy person's body over time. Researchers will compare the amount of enlicitide in a healthy person's body over time when different formulations are given on an empty stomach and after a high-fat meal.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is in good health
  • Has a body-mass index (BMI) between ≥18.0 and ≤32.0 kg/m^2

Exclusion criteria

  • Has history of gastrointestional (GI) disease which might affect food and drug absorption or has had gastric bypass or similar surgery. Examples of GI disease include (but are not limited to) recurrent vomiting, inflammatory bowel disease, chronic intestinal disease accompanied by a disturbance in digestion and absorption, Roemheld's syndrome, and severe hernia
  • Has a history of cancer (malignancy)
  • Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
  • Is lactose intolerant

Treatment and study plan

Enlicitide

Drug

Oral Tablet

Other names: MK-0616, enlicitide decanoate

Primary outcomes

  1. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Enlicitide in Plasma

    Time frame: Pre-dose and at designated timepoints (up to 168 hours post dose)

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

  2. Maximum Observed Plasma Concentration (Cmax) of Enlicitide in Plasma

    Time frame: Pre-dose and at designated timepoints (up to 168 hours post dose)

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

Secondary outcomes

  1. AUC0-inf of Enlicitide in Plasma Under Fed vs Fasted Conditions

    Time frame: Pre-dose and at designated timepoints (up to 168 hours post dose)

    Blood samples will be collected to determine the AUC0-inf of enlicitide under fed and fasted conditions.

  2. Cmax of Enlicitide in Plasma Under Fed vs Fasted Conditions

    Time frame: Pre-dose and at designated timepoints (up to 168 hours post dose)

    Blood samples will be collected to determine the Cmax of enlicitide under fed and fasted conditions.

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

    Time frame: Up to approximately 98 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.

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

    Time frame: Up to approximately 98 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 Test Formulations Under Fed and Fasted Conditions and Compare to the Reference FMF Tablet in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 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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