Status:
COMPLETED
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Non-alcoholic Steatohepatitis
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- 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
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06052566
Start Date
November 21 2023
End Date
December 5 2024
Last Update
October 22 2025
Active Locations (4)
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1
Clinical Pharmacology of Miami ( Site 0005)
Miami, Florida, United States, 33014-3616
2
Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida, United States, 33147
3
Genesis Clinical Research, LLC ( Site 0006)
Tampa, Florida, United States, 33603
4
American Research Corporation ( Site 0002)
San Antonio, Texas, United States, 78215