A Study of Efinopegdutide in Healthy Obese Participants (MK-6024-015)
- Conditions
- Interventions
- Registration Number
- NCT06701305
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 ...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 48
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
The main exclusion criteria include but are not limited to the following:
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- History of cancer (malignancy)
- Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or Human immunodeficiency virus (HIV)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Efinopegdutide Efinopegdutide Part 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide. Part 1: Placebo Placebo Part 1: Participants receive a single SC dose of placebo. Part 2: Efinopegdutide Efinopegdutide 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. Part 2: Efinopegdutide Acetaminophen 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. Part 2: Placebo Placebo 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. Part 2: Placebo Acetaminophen 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.
- Primary Outcome Measures
Name Time Method 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.
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 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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
QPS-MRA, LLC (Site 0001)
🇺🇸South Miami, Florida, United States