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NCT Number: NCT07300280

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

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.

Recruiting

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

888-577-8839

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-0616A

Drug

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

Other names: enlicitide/rosuvastatin calcium

Enlicitide

Drug

Oral tablet

Other names: MK-0616

Rosuvastatin

Drug

Oral tablet

Primary outcomes

  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

    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

    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

    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

    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

    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

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

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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