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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-023 | Other Identifier | MSD |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide Decanoate and Semaglutide | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide Decanoate | Drug | multiple doses, oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate | 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 | 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 | 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 | 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 | 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 | Blood samples will be collected to determine the Tmax of semaglutide. | At designated timepoints (up to approximately 2 weeks postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) | 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion (Site 0001) | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
| C000591245 | semaglutide |
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| Semaglutide | Drug | multiple doses, oral tablet |
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| Up to approximately 12 weeks |
| Number of Participants Who Discontinue Study Due to a TEAE | 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 |