A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)

NCT06880874 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-035MK-0616-035
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of enlicitide in plasma

  Blood samples will be collected to determine the AUC0-24hr of enlicitide.

  Pre-dose and at designated time points up to 24 hours post dose

• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide in plasma

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

  Pre-dose and at designated time points up to 168 hours post dose

• Area Under the Concentration-Time Curve from Time 0 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 time points up to 168 hours post dose

• Maximum Plasma Concentration (Cmax) of enlicitide in plasma

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

  Pre-dose and at designated time points up to 168 hours post dose

Secondary Outcomes (2)

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

  Up to approximately 14 days

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

  Up to approximately 8 days

Study Arms (2)

Treatment A: enlicitide reference tablet

EXPERIMENTAL

Participants receive a single oral dose of enlicitide reference tablet.

Drug: Enlicitide

Treatment B: enlicitide test tablet

EXPERIMENTAL

Participants receive a single oral dose of enlicitide test tablet.

Drug: Enlicitide

Interventions

Enlicitide DRUG

Oral Tablet

Also known as: MK-0616, enlicitide decanoate

Treatment A: enlicitide reference tablet; Treatment B: enlicitide test tablet

Eligibility Criteria

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

You may qualify if:

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
• Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

You may not qualify if:

• Has history of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
• Has history of cancer (malignancy)
• Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion ( Site 0001)

Tempe, Arizona, 85283, 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: March 12, 2025
• First Posted: March 18, 2025
• Study Start: April 2, 2025
• Primary Completion: May 16, 2025
• Study Completion: May 31, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)