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

Phase 1

Completed

Brief Summary: 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.
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Recruitment & Eligibility

Inclusion Criteria

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

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

Arm && Interventions

Group	Intervention	Description
Enlicitide Decanoate and Semaglutide	Enlicitide Decanoate	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.
Enlicitide Decanoate and Semaglutide	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate	At designated timepoints (up to 24 hours postdose)	Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Semaglutide	At designated timepoints (up to 24 hours postdose)	Blood samples will be collected to determine the AUC0-24hrs of semaglutide.
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate	At designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Maximum Plasma Concentration (Cmax) of Semaglutide	At designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the Cmax of semaglutide.
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate	At designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Time to Maximum Plasma Concentration (Tmax) of Semaglutide	At designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the Tmax of semaglutide.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)	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.
Number of Participants Who Discontinue Study Due to a TEAE	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.