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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-21

Study Completion Date

2024-12-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-alcoholic Steatohepatitis Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Efinopegdutide

Intervention Type DRUG

Subcutaneous injection administered at a dose of 7 mg

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.

Group Type EXPERIMENTAL

Efinopegdutide

Intervention Type DRUG

Subcutaneous injection administered at a dose of 7 mg

Efinopegdutide in Healthy-Matched Control Group

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

Group Type EXPERIMENTAL

Efinopegdutide

Intervention Type DRUG

Subcutaneous injection administered at a dose of 7 mg

Interventions

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Efinopegdutide

Subcutaneous injection administered at a dose of 7 mg

Intervention Type DRUG

Other Intervention Names

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MK-6024 HM12525A JNJ-64565111

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes