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

November 19, 2024 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

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
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • 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

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enlicitide Decanoate and Semaglutide

Period 1: Participants receive an oral dose of enlicitide decanoate every day for 1 week.

Period 2: Participants receive an oral dose of semaglutide every day for 6 weeks.

Period 3: Participants receive an oral dose of both enlicitide decanoate and semaglutide every day for 1 week.
Drug: Enlicitide Decanoate
multiple doses, oral tablet
Other Names:
  • MK-0616
Drug: Semaglutide
multiple doses, oral tablet
Other Names:
  • Rybelsus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At designated timepoints (up to 24 hours postdose)
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.
At designated timepoints (up to 24 hours postdose)
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.
At designated timepoints (up to approximately 2 weeks postdose)
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.
At designated timepoints (up to approximately 2 weeks postdose)
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.
At designated timepoints (up to approximately 2 weeks postdose)
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.
At designated timepoints (up to approximately 2 weeks postdose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 12 weeks
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.
Up to approximately 12 weeks

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)

January 22, 2024

Primary Completion (Actual)

May 24, 2024

Study Completion (Actual)

May 24, 2024

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0616-023
  • MK-0616-023 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/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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