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Trial · Interventional

Active, not recruitingPhase 1Registry data

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

NCTNCT07300280 (opens ClinicalTrials.gov in a new tab)Other id0616A-039
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 1
Enrollment
60 participants (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
29 Dec 2025
Primary completion
14 Oct 2026 (estimated)
Completion
21 Oct 2026 (estimated)
First posted
23 Dec 2025
Last update posted
23 Sept 2026
Conditions
Healthy

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 1

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

    NCT07300280

    29 Dec 2025 to est. 21 Oct 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • MK-0616ADrug
  • EnlicitideDrug
  • RosuvastatinDrug

Arms4

  • 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

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

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

  2. AUC0-Inf of Rosuvastatin

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

    Registry description

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

  3. 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

    Registry description

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

  4. AUC0-Last of Rosuvastatin

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

    Registry description

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

  5. Maximum Plasma Concentration (Cmax) of Enlicitide

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

    Registry description

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

  6. Cmax of Rosuvastatin

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

    Registry description

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

Secondary outcomes(2)

  1. Number of Participants who Experience an Adverse Event (AE)

    Time frame · Up to approximately 9 weeks

    Registry description

    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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame · Up to approximately 8 days after first dose

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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