A Study of Efinopegdutide in Healthy Obese Participants (MK-6024-015)

Phase 1
Active, not recruiting
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
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
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Exclusion Criteria

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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Part 1: EfinopegdutideEfinopegdutidePart 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide.
Part 1: PlaceboPlaceboPart 1: Participants receive a single SC dose of placebo.
Part 2: EfinopegdutideEfinopegdutidePart 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: EfinopegdutideAcetaminophenPart 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: PlaceboPlaceboPart 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: PlaceboAcetaminophenPart 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
NameTimeMethod
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 AEUp 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 EfinopegdutidePre-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 EfinopegdutidePre-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 EfinopegdutidePre-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 EfinopegdutidePre-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 EfinopegdutidePre-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 EfinopegdutidePre-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 EfinopegdutidePre-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 AEUp 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 EfinopegdutideAt designated time points up to approximately 184 days

Blood samples will be collected to determine the Cmax of Efinopegdutide.

Part 2: Tmax of EfinopegdutideAt 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 EfinopegdutideAt 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 EfinopegdutideAt 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 EfinopegdutideAt 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 EfinopegdutideAt designated time points up to approximately 184 days

Blood samples will be collected to determine the Ctrough of Efinopegdutide.

Secondary Outcome Measures
NameTimeMethod
Part 2: AUC0-Inf of AcetaminophenAt designated time points up to approximately 184 days

Blood samples will be collected to determine the AUC0-inf of Acetaminophen.

Part 2: Cmax of AcetaminophenAt designated time points up to approximately 184 days

Blood samples will be collected to determine the Cmax of Acetaminophen.

Part 2: Tmax of AcetaminophenAt designated time points up to approximately 184 days

Blood samples will be collected to determine the Tmax of Acetaminophen.

Part 2: t1/2 of AcetaminophenAt 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

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