A Single and Multiple-Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Efinopegdutide (MK-6024) in Otherwise Healthy Obese Participants and the Effect of Multiple Doses of Efinopegdutide on the Pharmacokinetics of Acetaminophen

Registration

Registration

NCT06701305

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

COMPLETED

Enrollment

48

Start

2024-06-13

Primary completion

2025-02-18

Lead sponsor

Merck Sharp & Dohme LLC

Conditions

Healthy

Interventions

DRUG:Efinopegdutide; DRUG:Placebo; DRUG:Acetaminophen

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER:MK-6024-015

Registered primary outcomes

• Part 1: Number of Participants Who Experience an Adverse Event (AE) [Up to approximately 35 days]
• Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE [Up to approximately 35 days]
• Part 1: Maximum Plasma Concentration (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 [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 [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 [Pre-dose and at designated time points up to 35 days post dose]
• Part 1: Apparent Terminal Half-life (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 [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 [Pre-dose and at designated time points up to 35 days post dose]
• Part 2: Number of Participants Who Experience an Adverse Event (AE) [Up to approximately 184 days]
• Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE [Up to approximately 184 days]
• Part 2: Cmax of Efinopegdutide [At designated time points up to approximately 184 days]
• Part 2: 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 [At designated time points up to approximately 184 days]
• Part 2: t1/2 of Efinopegdutide [At designated time points up to approximately 184 days]
• Part 2: 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 [At designated time points up to approximately 184 days]