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

March 16, 2026 updated by: Merck Sharp & Dohme LLC

A Clinical Study to Evaluate the Relative Bioavailability of FDC Tablets Containing Enlicitide and Rosuvastatin, Compared to Enlicitide and Rosuvastatin Administered Concomitantly as Single Entities, in Healthy Adult Participants

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion ( Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Rosuvastatin
Oral tablet
Drug: Enlicitide
Oral tablet
Other Names:
  • MK-0616
Experimental: MK-0616A Part 1
Participants in Part 1 will receive a single dose of MK-0616A
Drug: MK-0616A
Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets
Other Names:
  • enlicitide/rosuvastatin calcium
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
Drug: Rosuvastatin
Oral tablet
Drug: Enlicitide
Oral tablet
Other Names:
  • MK-0616
Experimental: MK-0616A Part 2
Participants in Part 2 will receive a single dose of MK-0616A formulation B
Drug: MK-0616A
Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets
Other Names:
  • enlicitide/rosuvastatin calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Pre dose and at designated time points up to 168 hours post dose
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
Time Frame: Pre dose and at designated time points up to 168 hours post dose
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
Time Frame: Pre dose and at designated time points up to 168 hours post dose
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
Time Frame: Pre dose and at designated time points up to 168 hours post dose
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
Time Frame: Pre dose and at designated time points up to 168 hours post dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who Experience an Adverse Event (AE)
Time Frame: Up to approximately 9 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to approximately 9 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 8 days after first dose
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 8 days after first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2025

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 22, 2026

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0616A-039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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