Metabolic Dysfunction-Associated Steatotic Liver Disease(MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Conditions
Brief summary
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
Detailed 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
Interventions
Sponsors
89bio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria, Belgium, Bulgaria, Czechia, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed