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Completed

NCT Number: NCT06699329

A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023)

The goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate and semaglutide alone or at the same time. Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Semaglutide is a drug used to treat type 2 diabetes.

Researchers want to learn what happens to the amount of semaglutide and enlicitide decanoate in a person's blood when each drug is taken alone and when they are taken together.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

  • Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
  • Medically healthy with no clinically significant medical history

Exclusion criteria

The key exclusion criteria include but are not limited to the following:

  • History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
  • History of cancer

Treatment and study plan

Enlicitide Decanoate

Drug

multiple doses, oral tablet

Other names: MK-0616

semaglutide

Drug

multiple doses, oral tablet

Other names: Rybelsus

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to 24 hours postdose)

    Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.

  2. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Semaglutide

    Time frame: At designated timepoints (up to 24 hours postdose)

    Blood samples will be collected to determine the AUC0-24hrs of semaglutide.

  3. Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 2 weeks postdose)

    Blood samples will be collected to determine the Cmax of enlicitide decanoate.

  4. Maximum Plasma Concentration (Cmax) of Semaglutide

    Time frame: At designated timepoints (up to approximately 2 weeks postdose)

    Blood samples will be collected to determine the Cmax of semaglutide.

  5. Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 2 weeks postdose)

    Blood samples will be collected to determine the Tmax of enlicitide decanoate.

  6. Time to Maximum Plasma Concentration (Tmax) of Semaglutide

    Time frame: At designated timepoints (up to approximately 2 weeks postdose)

    Blood samples will be collected to determine the Tmax of semaglutide.

Secondary outcomes

  1. Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)

    Time frame: Up to approximately 12 weeks

    An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who experience a TEAE will be reported.

  2. Number of Participants Who Discontinue Study Due to a TEAE

    Time frame: Up to approximately 12 weeks

    An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who discontinue study due to a TEAE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Effect of MK-0616 and Semaglutide on Their Respective Pharmacokinetics in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

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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