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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Hepatic Impairment; Non-alcoholic Steatohepatitis

Treatments: Drug: Efinopegdutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06052566

6024-014

MK-6024-014 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Efinopegdutide in Participants with Moderate Hepatic Impairment

Experimental group

Description:

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

Treatment:

Drug: Efinopegdutide

Efinopegdutide in Participants with Severe Hepatic Impairment

Experimental group

Description:

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

Treatment:

Drug: Efinopegdutide

Efinopegdutide in Healthy-Matched Control Group

Experimental group

Description:

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

Treatment:

Drug: Efinopegdutide