A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Trial status: Authorised
1_Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52, 2_Percent Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36, 3_Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events Up to Month 36, 4_Absolute change from baseline in ELF score at 52 weeks
1_Proportion of participants achieving the co-primary endpoints measured at 52 weeks of: _ Improvement in fibrosis by ≥1 stage without worsening of steatohepatitis -resolution of steatohepatitis without worsening of fibrosis
Description
1_Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52, 2_Percent Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36, 3_Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events Up to Month 36, 4_Absolute change from baseline in ELF score at 52 weeks
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 260 participants
Interventions
Pegozafermin
Drug
Placebo for pegozafermin. combined integral administration device: pre-filled syringe - please refer to the IMPD pegozafermin section 3.2.p.7 container closure system for detailed description.
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