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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6024-015 | Other Identifier | MSD |
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The goal of this study is to learn about the safety of efinopegdutide (MK-6024) and how well overweight healthy people tolerate it. Researchers also want to know what happens to efinopegdutide in a person's body over time when taken as a single dose (Part 1) or as multiple doses (Part 2). In addition, the study will assess the amount of acetaminophen in the blood after receiving different strength doses of efinopegdutide (Part 2 only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Efinopegdutide | Experimental | Part 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide. |
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| Part 1: Placebo | Placebo Comparator | Part 1: Participants receive a single SC dose of placebo. |
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| Part 2: Efinopegdutide | Experimental | Part 2: Participants receive multiple SC doses of efinopegdutide titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of efinopegdutide, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83. |
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| Part 2: Placebo | Placebo Comparator | Part 2: Participants receive multiple SC doses of Placebo titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of Placebo, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efinopegdutide | Drug | Subcutaneous injectable solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: 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 35 days |
| Part 1: 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 35 days |
| Part 1: Maximum Plasma Concentration (Cmax) of Efinopegdutide | Blood samples will be collected to determine the Cmax of Efinopegdutide. | Pre-dose and at designated time points up to 35 days post dose |
| Part 1: Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide | Blood samples will be collected to determine the Tmax of Efinopegdutide. | Pre-dose and at designated time points up to 35 days post dose |
| Part 1: Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-last) of Efinopegdutide | Blood samples will be collected to determine the AUC0-last of Efinopegdutide. | Pre-dose and at designated time points up to 35 days post dose |
| Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Efinopegdutide |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: AUC0-Inf of Acetaminophen | Blood samples will be collected to determine the AUC0-inf of Acetaminophen. | At designated time points up to approximately 184 days |
| Part 2: Cmax of Acetaminophen |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main 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 |
|---|---|---|---|---|---|---|
| QPS-MRA, LLC (Site 0001) | South Miami | Florida | 33143 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | Subcutaneous injectable solution |
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| Acetaminophen | Drug | Oral solution |
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Blood samples will be collected to determine the AUC0-Inf of Efinopegdutide.
| Pre-dose and at designated time points up to 35 days post dose |
| Part 1: Apparent Terminal Half-life (t1/2) of Efinopegdutide | Blood samples will be collected to determine the t1/2 of Efinopegdutide. | Pre-dose and at designated time points up to 35 days post dose |
| Part 1: Apparent Clearance (CL/F) of Efinopegdutide | Blood samples will be collected to determine the CL/F of Efinopegdutide. | Pre-dose and at designated time points up to 35 days post dose |
| Part 1: Apparent volume of distribution during terminal phase (Vz/F) of Efinopegdutide | Blood samples will be collected to determine the Vz/F of Efinopegdutide. | Pre-dose and at designated time points up to 35 days post dose |
| Part 2: 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 184 days |
| Part 2: 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 184 days |
| Part 2: Cmax of Efinopegdutide | Blood samples will be collected to determine the Cmax of Efinopegdutide. | At designated time points up to approximately 184 days |
| Part 2: Tmax of Efinopegdutide | Blood samples will be collected to determine the Tmax of Efinopegdutide. | At designated time points up to approximately 184 days |
| Part 2: Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Interval (AUC0-tau) of Efinopegdutide | Blood samples will be collected to determine the AUC0-tau of Efinopegdutide. | At designated time points up to approximately 184 days |
| Part 2: t1/2 of Efinopegdutide | Blood samples will be collected to determine the CL/F of Efinopegdutide. | At designated time points up to approximately 184 days |
| Part 2: Vz/F of Efinopegdutide | Blood samples will be collected to determine the Vz/F of Efinopegdutide. | At designated time points up to approximately 184 days |
| Part 2: Concentration Immediately Before the Next Dose is Administered (Ctrough) of Efinopegdutide | Blood samples will be collected to determine the Ctrough of Efinopegdutide. | At designated time points up to approximately 184 days |
Blood samples will be collected to determine the Cmax of Acetaminophen.
| At designated time points up to approximately 184 days |
| Part 2: Tmax of Acetaminophen | Blood samples will be collected to determine the Tmax of Acetaminophen. | At designated time points up to approximately 184 days |
| Part 2: t1/2 of Acetaminophen | Blood samples will be collected to determine the t1/2 of Acetaminophen. | At designated time points up to approximately 184 days |
| Aniline Compounds |
| D000588 | Amines |