Phase
Condition
Liver Disease
Primary Biliary Cholangitis
Treatment
Efinopegdutide
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 orbreastfeeding, is not a participant of childbearing potential (POCBP), or is a POCBPand agrees to follow contraceptive guidance during the study intervention period andfor at least 35 days after the last dose of study intervention.
For participants with moderate or severe hepatic impairment: Have a diagnosis ofchronic (>6 months), stable, hepatic impairment with features of cirrhosis due toany etiology (stability of hepatic disease should correspond to no acute episodes ofillness within the previous 2 months due to deterioration in hepatic function).
Exclusion
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 humanimmunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit.
Participants with moderate or severe hepatic impairment who received antiviraland/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 anymedication, including prescription and nonprescription drugs or herbal remediesbeginning approximately 2 weeks (or 5 half-lives) prior to administration of theinitial dose of study intervention, throughout the study (including washoutintervals between treatment periods), until the poststudy visit.
Study Design
Connect with a study center
Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida 33147
United StatesSite Not Available
Clinical Pharmacology of Miami ( Site 0005)
Miami, Florida 33014-3616
United StatesSite Not Available
Genesis Clinical Research, LLC ( Site 0006)
Tampa, Florida 33603
United StatesSite Not Available
American Research Corporation ( Site 0002)
San Antonio, Texas 78215
United StatesSite Not Available
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