An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Efinopegdutide (MK-6024) in Participants With Moderate and Severe Hepatic Impairment

Registration

Registration

NCT06052566

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

22

Start

2023-11-21

Primary completion

2024-12-05

Lead sponsor

Merck Sharp & Dohme LLC

Conditions

Non-alcoholic Steatohepatitis; Hepatic Impairment

Interventions

DRUG:Efinopegdutide

Results posted

TRUE

Individual participant data sharing

YES

Secondary identifiers

REGISTRY:MK-6024-014

Registered primary outcomes

• Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide [At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35]
• Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide [At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35]
• Maximum Plasma Concentration (Cmax) of Efinopegdutide [At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35]
• Time to Maximum Concentration (Tmax) of Efinopegdutide [At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35]
• Apparent Terminal Half-life (t/12) of Efinopegdutide [At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35]
• Apparent Total Clearance (CL/F) of Efinopegdutide [At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35]
• Apparent Volume of Distribution (Vz/F) of Efinopegdutide [At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35]