Healthy
Conditions
Brief summary
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).
Interventions
DRUGEfinopegdutide
Subcutaneous injectable solution
DRUGPlacebo
Subcutaneous injectable solution
DRUGAcetaminophen
Oral solution
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Is in good health * Has body mass index (BMI) between 29 kg/m\^2 and 38 kg/m\^2
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Concentration Immediately Before the Next Dose is Administered (Ctrough) of Efinopegdutide | At designated time points up to approximately 184 days | Blood samples will be collected to determine the Ctrough of Efinopegdutide. |
| Part 2: Tmax of Efinopegdutide | At designated time points up to approximately 184 days | Blood samples will be collected to determine the Tmax of Efinopegdutide. |
| Part 2: Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Interval (AUC0-tau) of Efinopegdutide | At designated time points up to approximately 184 days | Blood samples will be collected to determine the AUC0-tau of Efinopegdutide. |
| Part 2: t1/2 of Efinopegdutide | At designated time points up to approximately 184 days | Blood samples will be collected to determine the CL/F of Efinopegdutide. |
| Part 2: Vz/F of Efinopegdutide | At designated time points up to approximately 184 days | Blood samples will be collected to determine the Vz/F of Efinopegdutide. |
| Part 1: Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 35 days | 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. |
| Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 35 days | 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. |
| Part 1: Maximum Plasma Concentration (Cmax) of Efinopegdutide | Pre-dose and at designated time points up to 35 days post dose | Blood samples will be collected to determine the Cmax of Efinopegdutide. |
| Part 1: Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide | Pre-dose and at designated time points up to 35 days post dose | Blood samples will be collected to determine the Tmax of Efinopegdutide. |
| Part 1: Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-last) of Efinopegdutide | Pre-dose and at designated time points up to 35 days post dose | Blood samples will be collected to determine the AUC0-last of Efinopegdutide. |
| Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Efinopegdutide | Pre-dose and at designated time points up to 35 days post dose | Blood samples will be collected to determine the AUC0-Inf of Efinopegdutide. |
| Part 1: Apparent Terminal Half-life (t1/2) of Efinopegdutide | Pre-dose and at designated time points up to 35 days post dose | Blood samples will be collected to determine the t1/2 of Efinopegdutide. |
| Part 1: Apparent Clearance (CL/F) of Efinopegdutide | Pre-dose and at designated time points up to 35 days post dose | Blood samples will be collected to determine the CL/F of Efinopegdutide. |
| Part 1: Apparent volume of distribution during terminal phase (Vz/F) of Efinopegdutide | Pre-dose and at designated time points up to 35 days post dose | Blood samples will be collected to determine the Vz/F of Efinopegdutide. |
| Part 2: Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 184 days | 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. |
| Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 184 days | 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. |
| Part 2: Cmax of Efinopegdutide | At designated time points up to approximately 184 days | Blood samples will be collected to determine the Cmax of Efinopegdutide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Cmax of Acetaminophen | At designated time points up to approximately 184 days | Blood samples will be collected to determine the Cmax of Acetaminophen. |
| Part 2: Tmax of Acetaminophen | At designated time points up to approximately 184 days | Blood samples will be collected to determine the Tmax of Acetaminophen. |
| Part 2: t1/2 of Acetaminophen | At designated time points up to approximately 184 days | Blood samples will be collected to determine the t1/2 of Acetaminophen. |
| Part 2: AUC0-Inf of Acetaminophen | At designated time points up to approximately 184 days | Blood samples will be collected to determine the AUC0-inf of Acetaminophen. |
Countries
United States
Outcome results
None listed