A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
Non-alcoholic Steatohepatitis, Hepatic Impairment
About this trial
This is an interventional treatment trial for Non-alcoholic Steatohepatitis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Efinopegdutide in Participants with Moderate Hepatic Impairment
Efinopegdutide in Participants with Severe Hepatic Impairment
Efinopegdutide in Healthy-Matched Control Group
Participants with moderate hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.
Participants with severe hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Healthy matched participants receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.