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

NCT06052566 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 6024-014MK-6024-014
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Non-alcoholic Steatohepatitis; Hepatic Impairment

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Number of Participants Who Experienced an Adverse Event (AE)

  Up to 35 days

• Number of Participants Who Discontinued Study Intervention Due to an AE

  Up to 35 days

Study Arms (3)

Efinopegdutide in Participants with Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.

Drug: Efinopegdutide

Efinopegdutide in Participants with Severe Hepatic Impairment

EXPERIMENTAL

Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.

Drug: Efinopegdutide

Efinopegdutide in Healthy-Matched Control Group

EXPERIMENTAL

Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.

Drug: Efinopegdutide

Interventions

Efinopegdutide DRUG

Subcutaneous injection administered at a dose of 7 mg

Also known as: MK-6024, HM12525A, JNJ-64565111

Efinopegdutide in Healthy-Matched Control Group; Efinopegdutide in Participants with Moderate Hepatic Impairment; Efinopegdutide in Participants with Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (4)

Clinical Pharmacology of Miami ( Site 0005)

Miami, Florida, 33014-3616, United States

Location

Advanced Pharma CR, LLC ( Site 0001)

Miami, Florida, 33147, United States

Location

Genesis Clinical Research, LLC ( Site 0006)

Tampa, Florida, 33603, United States

Location

American Research Corporation ( Site 0002)

San Antonio, Texas, 78215, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: November 21, 2023
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (4)