A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)

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

The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment; Non-alcoholic Steatohepatitis
• Intervention / Treatment: Drug: Efinopegdutide

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014-3616
      • Clinical Pharmacology of Miami ( Site 0005)
    • Miami, Florida, United States, 33147
      • Advanced Pharma CR, LLC ( Site 0001)
    • Tampa, Florida, United States, 33603
      • Genesis Clinical Research, LLC ( Site 0006)
  • Texas
    • San Antonio, Texas, United States, 78215
      • American Research Corporation ( Site 0002)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• A participant assigned female at birth is eligible to participate if not pregnant or breastfeeding, is not a participant of childbearing potential (POCBP), or is a POCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 35 days after the last dose of study intervention.
• For participants with moderate or severe hepatic impairment: Have a diagnosis of chronic (>6 months), stable, hepatic impairment with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function).

Exclusion Criteria:

• History of cancer (malignancy).
• Had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
• Participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit.
• Participants with moderate or severe hepatic impairment who received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start.
• Healthy participants who are unable to refrain from or anticipate the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efinopegdutide in Participants with Moderate Hepatic Impairment; Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.	Drug: Efinopegdutide; Subcutaneous injection administered at a dose of 7 mg; Other Names: MK-6024; HM12525A; JNJ-64565111
Experimental: Efinopegdutide in Participants with Severe Hepatic Impairment; Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Drug: Efinopegdutide; Subcutaneous injection administered at a dose of 7 mg; Other Names: MK-6024; HM12525A; JNJ-64565111
Experimental: Efinopegdutide in Healthy-Matched Control Group; Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.	Drug: Efinopegdutide; Subcutaneous injection administered at a dose of 7 mg; Other Names: MK-6024; HM12525A; JNJ-64565111

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide	Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.	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	Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-last.	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	Blood samples collected at multiple timepoints post-dose were used to determine the Cmax.	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	Blood samples collected at multiple timepoints post-dose were used to determine the 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	Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.	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	Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.	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	Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced an Adverse Event (AE)	An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.	Up to 35 days
Number of Participants Who Discontinued Study Intervention Due to an AE	An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.	Up to 35 days

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): December 5, 2024
• Study Completion (Actual): December 5, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 6024-014; MK-6024-014 (Registry Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No