A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Compensated Cirrhosis

1_At interim analysis: Proportion of subjects achieving fibrosis regression, defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy, 2_At study completion: Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events

1_At interim analysis and study completion: Change from baseline in ELF score, 2_At interim analysis and study completion: Change from baseline in ALT, 3_At interim analysis and study completion: Change from baseline in FibroScan VCTE, 4_At study completion: Proportion of subjects who develop CSPH, 5_At study completion: Time to progression to large gastric or esophageal varices and/or varices with “red-wale” signs or endoscopic treatment of esophageal or gastric varices, 6_At study completion: Time to clinically important ascites as determined by the onset of Grade ≥2 (clinically apparent) ascites leading to diagnostic paracentesis or initiation of specific treatment for ascites (e.g., diuretics, therapeutic paracentesis, or TIPS), 7_At study completion: Time to overt hepatic encephalopathy (altered mental status without alternate explanation requiring acute medical attention and either initiation of specific therapy or modification of existing treatment)

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