The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,350
Subcutaneous injection
Subcutaneous injection
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52
Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis
Time frame: Week 52
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52
Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Time frame: Week 52
Time to First Occurrence of Disease Progression
Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
Time frame: Up to 5 years
Percent Change from Baseline in Alanine Aminotransferase at Week 52
Time frame: Baseline, Week 52
Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52
Time frame: Baseline, Week 52
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