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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6024-011 | Other Identifier | MSD | |
| 2020-005136-30 | Registry Identifier | EU CT |
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The goal of this study is to learn about the safety and whether people tolerate a study medicine called efinopegdutide. The study will also measure what happens to efinopegdutide in a healthy person's body over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efinopegdutide Low Dose | Experimental | Participants receive low dose efinopegdutide at a single dose on day 1 |
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| Efinopegdutide Medium dose | Experimental | Participants receive medium dose efinopegdutide at a single dose on day 1 |
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| Efinopegdutide High Dose | Experimental | Participants receive high dose efinopegdutide at a single dose on day 1 |
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| Efinopegdutide Multiple Dose | Experimental | Participants receive multiple doses of efinopegdutide over 78 days |
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| Placebo | Placebo Comparator | Participants receive placebo to match efinopegdutide dose and regimen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efinopegdutide | Drug | Subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 112 days |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 78 days |
| Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose | Blood samples will be collected to determine the Cmax of efinopegdutide when administered as a single dose | At designated time points up to 35 days |
| Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose | Blood samples will be collected to determine the Tmax of efinopegdutide when administered as a single dose | At designated time points up to 35 days |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose | Blood samples will be collected to determine the AUC0-last of efinopegdutide when administered as a single dose | At designated timepoints up to 35 days |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Weight | Change from baseline in weight will be computed for participants who received multiple doses of efinopegdutide | Baseline and day 112 |
| Change from Baseline in HDL Cholesterol |
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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 |
|---|---|---|---|---|---|---|
| Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001) | Shanghai | Shanghai Municipality | 200032 | China |
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| Label | URL |
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| Merck Clinical Trials Information | View source |
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| Placebo | Drug | placebo matching efinopegdutide |
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Blood samples will be collected to determine the AUC0-inf of efinopegdutide when administered as a single dose |
| At designated timepoints up to 35 days |
| Terminal half life (t1/2) of Efinopegdutide- single dose | Blood samples will be collected to determine the t1/2 of efinopegdutide when administered as a single dose | At designated timepoints up to 35 days |
| Apparent Clearance (CL) of Efinopegdutide- single dose | Blood samples will be collected to determine the CL of efinopegdutide when administered as a single dose | At designated timepoints up to 35 days |
| Volume of Distribution (Vz) of Efinopegdutide- single dose | Blood samples will be collected to determine the Vz of efinopegdutide when administered as a single dose | At designated timepoints up to 35 days |
| Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose | Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered | At designated time points up to 112 days |
| Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose | Blood samples will be collected to determine the Cmin of efinopegdutide when multiple doses are administered | At designated time points up to 112 days |
| Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose | Blood samples will be collected to determine the Tmax of efinopegdutide when multiple doses are administered | At designated time points up to 112 days |
| Terminal half life (t1/2) of Efinopegdutide- multiple dose | Blood samples will be collected to determine the t1/2 of efinopegdutide when multiple doses are administered | At designated timepoints up to 112 days |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose | Blood samples will be collected to determine the AUC0-last of efinopegdutide when multiple doses are administered | At designated timepoints up to 112 days |
| Apparent Clearance (CL) of Efinopegdutide- multiple dose | Blood samples will be collected to determine the CL of efinopegdutide when multiple doses are administered | At designated timepoints up to 112 days |
| Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose | Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered | At designated timepoints up to 112 days |
| Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose | Blood samples will be collected to determine the AUC0 to tau of efinopegdutide when multiple doses are administered | At designated timepoints up to 78 days |
Change from baseline in HDL cholesterol will be computed for participants who received multiple doses of efinopegdutide
| Baseline and day 112 |
| Change from Baseline in LDL Cholesterol | Change from baseline in LDL cholesterol will be computed for participants who received multiple doses of efinopegdutide | Baseline and day 112 |
| Change from Baseline in Total Cholesterol | Change from baseline in total cholesterol will be computed for participants who received multiple doses of efinopegdutide | Baseline and day 112 |
| Change from Baseline in Triglycerides | Change from baseline in triglycerides will be computed for participants who received multiple doses of efinopegdutide | Baseline and day 112 |
| Number of participants with anti drug antibodies (ADA) to efinopegdutide | Blood samples will be collected to determine the number of participants with ADA to efinopegdutide | At designated timepoints up to 112 days |