Oral and Gastrointestinal
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction Associated Steatohepatitis (MASH)
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of pegozafermin for the treatment of Stage 2 or 3 liver fibrosis in adult subjects with NASH (Noncirrhotic Nonalcoholic Steatohepatitis).
The study is designed to assess the efficacy and safety of 2 dose regimens of pegozafermin, administered either weekly (QW) or once every 2 weeks (Q2W) in subjects with biopsy-confirmed NASH (NAFLD activity score [NAS] ≥ 4, fibrosis stage F2 or F3 [NASH CRN system]).
Approximately 840 subjects will be randomized 1:1:1 ...
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