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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07776665
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Enlicitide — DRUG
    Oral Tablet

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Dec 14, 2026
Completion
Dec 21, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment A: Enlicitide Reference
    Participants will receive a single oral dose of enlicitide reference formulation.
  • Experimental: Treatment B: Enlicitide Formulation Test 1 - Fed
    Participants will receive a single oral dose of enlicitide formulation test 1 after a high-fat breakfast.
  • Experimental: Treatment C: Enlicitide Formulation Test 1 - Fasted
    Participants will receive a single oral dose of enlicitide formulation test 1 under fasted conditions.
  • Experimental: Treatment D: Enlicitide Formulation Test 2 - Fed
    Participants will receive a single oral dose of enlicitide formulation test 2 after a high-fat breakfast.
  • Experimental: Treatment E: Enlicitide Formulation Test 2 - Fasted
    Participant will receive a single oral dose of enlicitide formulation test 2 under fasted conditions.

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion ( Site 0001)LincolnNebraska68502
Study Coordinator
402-476-2811

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Celerion· Lincoln, NE

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