A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)

NCT07300280 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 0616A-039
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This goal of this trial is to learn about two medicines, enlicitide and rosuvastatin, in healthy people. Researchers will compare the amounts of enlicitide and rosuvastatin in a person's body over time, when they are given as separate medicines and when they are combined into one tablet.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide

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

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

• AUC0-Inf of Rosuvastatin

  Blood samples will be collected to determine the AUC0-inf of rosuvastatin in plasma

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

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

  Blood samples will be collected to determine the AUC0-last of enlicitide in plasma

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

• AUC0-Last of Rosuvastatin

  Blood samples will be collected to determine the AUC0-last of rosuvastatin in plasma

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

• Maximum Plasma Concentration (Cmax) of Enlicitide

  Blood samples will be collected to determine the cmax of enlicitide in plasma

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

• Cmax of Rosuvastatin

  Blood samples will be collected to determine the cmax of rosuvastatin in plasma

  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 9 weeks

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

  Up to approximately 8 days after first dose

Study Arms (4)

Enlicitide + Rosuvastatin Part 1

EXPERIMENTAL

Participants in Part 1 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet

Drug: Enlicitide; Drug: Rosuvastatin

MK-0616A Part 1

EXPERIMENTAL

Participants in Part 1 will receive a single dose of MK-0616A

Drug: MK-0616A

Enlicitide + Rosuvastatin Part 2

EXPERIMENTAL

Participants in Part 2 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet

Drug: Enlicitide; Drug: Rosuvastatin

MK-0616A Part 2

EXPERIMENTAL

Participants in Part 2 will receive a single dose of MK-0616A formulation B

Drug: MK-0616A

Interventions

MK-0616A DRUG

Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets

Also known as: enlicitide/rosuvastatin calcium

MK-0616A Part 1; MK-0616A Part 2

Enlicitide DRUG

Oral tablet

Also known as: MK-0616

Enlicitide + Rosuvastatin Part 1; Enlicitide + Rosuvastatin Part 2

Rosuvastatin DRUG

Oral tablet

Enlicitide + Rosuvastatin Part 1; Enlicitide + Rosuvastatin Part 2

Eligibility Criteria

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

You may qualify if:

• Is medically healthy with no clinically significant medical history
• Is a non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to study entry

You may not qualify if:

• Is unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to study entry
• Is a female participant of childbearing potential

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

Rosuvastatin Calcium; MK-0616

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: December 10, 2025
• First Posted: December 23, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 22, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)