Recruiting
Phase 1

Enlicitide

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07776665

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

Interventions

Enlicitide

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT07776665

Start date

Aug 31, 2026

Status verified date

Aug, 2026

Completion date

Dec 21, 2026

Anticipated

Primary completion date

Dec 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 55

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Enlicitide

Oral Tablet

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) ]
  • Maximum Observed Plasma Concentration (Cmax) of Enlicitide in Plasma [ Time Frame: Pre-dose and at designated timepoints (up to 168 hours post dose) ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@merck.com

Locations

Celerion ( Site 0001)

Recruiting

Lincoln, Nebraska, United States, 68502

Contacts

Study Coordinator

402-476-2811

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-26.