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

NCT07776665 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 0616-044
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

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

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

• Maximum Observed Plasma Concentration (Cmax) of Enlicitide in Plasma

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

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

Secondary Outcomes (4)

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

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

• Cmax of Enlicitide in Plasma Under Fed vs Fasted Conditions

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

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 98 days

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 98 days

Study Arms (5)

Treatment A: Enlicitide Reference

EXPERIMENTAL

Participants will receive a single oral dose of enlicitide reference formulation.

Drug: Enlicitide

Treatment B: Enlicitide Formulation Test 1 - Fed

EXPERIMENTAL

Participants will receive a single oral dose of enlicitide formulation test 1 after a high-fat breakfast.

Drug: Enlicitide

Treatment C: Enlicitide Formulation Test 1 - Fasted

EXPERIMENTAL

Participants will receive a single oral dose of enlicitide formulation test 1 under fasted conditions.

Drug: Enlicitide

Treatment D: Enlicitide Formulation Test 2 - Fed

EXPERIMENTAL

Participants will receive a single oral dose of enlicitide formulation test 2 after a high-fat breakfast.

Drug: Enlicitide

Treatment E: Enlicitide Formulation Test 2 - Fasted

EXPERIMENTAL

Participant will receive a single oral dose of enlicitide formulation test 2 under fasted conditions.

Drug: Enlicitide

Interventions

Enlicitide DRUG

Oral Tablet

Also known as: MK-0616, enlicitide decanoate

Treatment A: Enlicitide Reference; Treatment B: Enlicitide Formulation Test 1 - Fed; Treatment C: Enlicitide Formulation Test 1 - Fasted; Treatment D: Enlicitide Formulation Test 2 - Fed; Treatment E: Enlicitide Formulation Test 2 - Fasted

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion ( Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

MK-0616

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)