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Clinical Trials in the USA / NCT07776665
Active, not recruiting Phase 1

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

NCT07776665 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1
Started
2026-08-31
Last updated
2026-09-18

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

Enlicitide →

Enlicitide: Oral Tablet

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
55 Years
Healthy volunteers
Accepted
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 gastrointestinal (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

Primary outcome measure(s)

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Enlicitide in Plasma — Pre-dose and at designated timepoints (up to 168 hours post dose)
    Blood samples will be collected to determine the AUC0-inf of enlicitide.
  • Maximum Observed Plasma Concentration (Cmax) of Enlicitide in Plasma — Pre-dose and at designated timepoints (up to 168 hours post dose)
    Blood samples will be collected to determine the Cmax of enlicitide.

Trial sites (1)

FacilityCityRegionStatus
Celerion ( Site 0001) Lincoln Nebraska

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07776665 on ClinicalTrials.gov ↗ ← All trials in the USA