The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
762
Subcutaneous injection
Subcutaneous injection
Proportion of Participants Achieving Fibrosis Regression
Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.
Time frame: Baseline through Month 24
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
Time frame: Baseline up to 5 years
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score
Time frame: Baseline, up to Month 60
Change from Baseline in Alanine Aminotransferase (ALT) Level
Time frame: Baseline, up to Month 60
Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)
Time frame: Baseline, up to Month 60
Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)
Time frame: Baseline up to Month 60
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89bio Clinical Study Site
Birmingham, Alabama, United States
RECRUITING89bio Clinical Study Site
Homewood, Alabama, United States
RECRUITING89bio Clinical Study Site
Chandler, Arizona, United States
RECRUITING89bio Clinical Study Site
Flagstaff, Arizona, United States
WITHDRAWN89bio Clinical Study Site
Peoria, Arizona, United States
RECRUITING89bio Clinical Study Site
Phoenix, Arizona, United States
RECRUITING89bio Clinical Study Site
Tucson, Arizona, United States
RECRUITING89bio Clinical Study Site
Tucson, Arizona, United States
RECRUITING89bio Clinical Study Site
Tucson, Arizona, United States
RECRUITING89bio Clinical Study Site
Little Rock, Arkansas, United States
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