Recruiting
Phase 1

Enlicitide & Rosuvastatin

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07300280

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

MK-0616A

Enlicitide

Rosuvastatin

Study Details

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

Study ID

NCT07300280

Start date

Dec 29, 2025

Status verified date

Jun, 2026

Completion date

Oct 21, 2026

Anticipated

Primary completion date

Oct 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

The main inclusion criteria include but are not limited to the following:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Enlicitide + Rosuvastatin Part 1

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

experimental: MK-0616A Part 1

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

experimental: Enlicitide + Rosuvastatin Part 2

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

experimental: MK-0616A Part 2

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

Interventions

MK-0616A

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

Enlicitide

Oral tablet

Rosuvastatin

Oral tablet

Primary outcome measure

  • Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide [ Time Frame: Pre dose and at designated time points up to 168 hours post dose ]
  • AUC0-Inf of Rosuvastatin [ Time Frame: 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 [ Time Frame: Pre dose and at designated time points up to 168 hours post dose ]
  • AUC0-Last of Rosuvastatin [ Time Frame: Pre dose and at designated time points up to 168 hours post dose ]
  • Maximum Plasma Concentration (Cmax) of Enlicitide [ Time Frame: Pre dose and at designated time points up to 168 hours post dose ]
  • Cmax of Rosuvastatin [ Time Frame: Pre dose and at designated time points up to 168 hours post dose ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

Celerion ( Site 0001)

Recruiting

Tempe, Arizona, United States, 85283

Contacts

Study Coordinator

888-577-8839

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Jun 9, 2026

Last verified

Jun, 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 2026-06-09.