Metabolic Dysfunction-Associated Steatohepatitis (MASH), Non Alcoholic Steatohepatitis (NASH)
Conditions
Brief summary
The primary clinical outcomes analysis will be Event-Free Survival (EFS). EFS will be assessed by time from randomization to the first clinical event including evidence of disease progression, liver decompensation events, liver transplantation or eligibility for liver transplantation, and all-cause mortality., Primary Endpoint at Week 96 based on liver biopsy (Cohort 1 only): The primary histology efficacy analysis will be conducted when all of the planned subjects in Cohort 1 complete the Week 96 visit (or prematurely discontinue). A Cochran-Mantel-Haenszel (CMH) test will be used to compare the differences in proportions of subjects who achieve a ≥ 1 stage improvement in fibrosis without worsening of steatohepatitis at Week 96 between the EFX arm and placebo arm, adjusting for stratification factors
Detailed description
Change from baseline in ELF score and components (tissue inhibitor of metalloproteinase-1 [TIMP-1], hyaluronic acid [HA], amino terminal pro-peptide of type 3 procollagen [PIIINP]), pro-peptide of type 3 procollagen (Pro-C3), and liver stiffness assessed by FibroScan, Change from baseline in ALT and AST, Change from baseline in total cholesterol, TG, high density lipoprotein cholesterol (HDL-C), non-HDL-C, and low-density lipoprotein cholesterol (LDL-C), Change from baseline in HbA1c, C-peptide, adiponectin, insulin, and HOMA-IR, Change from baseline in body weight, Cohort 1 only: Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 96, Cohort 1 only: Proportion of subjects who achieve NASH/MASH resolution (defined as a NAS of 0–1 for inflammation and 0 for ballooning) as determined by the NASH CRN criteria at Week 96, Cohort 1 only: Proportion of subjects who achieve NASH/MASH resolution (defined as a NAS of 0–1 for inflammation and 0 for ballooning) AND ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 96
Interventions
Sponsors
Akero Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical outcomes analysis will be Event-Free Survival (EFS). EFS will be assessed by time from randomization to the first clinical event including evidence of disease progression, liver decompensation events, liver transplantation or eligibility for liver transplantation, and all-cause mortality., Primary Endpoint at Week 96 based on liver biopsy (Cohort 1 only): The primary histology efficacy analysis will be conducted when all of the planned subjects in Cohort 1 complete the Week 96 visit (or prematurely discontinue). A Cochran-Mantel-Haenszel (CMH) test will be used to compare the differences in proportions of subjects who achieve a ≥ 1 stage improvement in fibrosis without worsening of steatohepatitis at Week 96 between the EFX arm and placebo arm, adjusting for stratification factors | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in ELF score and components (tissue inhibitor of metalloproteinase-1 [TIMP-1], hyaluronic acid [HA], amino terminal pro-peptide of type 3 procollagen [PIIINP]), pro-peptide of type 3 procollagen (Pro-C3), and liver stiffness assessed by FibroScan, Change from baseline in ALT and AST, Change from baseline in total cholesterol, TG, high density lipoprotein cholesterol (HDL-C), non-HDL-C, and low-density lipoprotein cholesterol (LDL-C), Change from baseline in HbA1c, C-peptide, adiponectin, insulin, and HOMA-IR, Change from baseline in body weight, Cohort 1 only: Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 96, Cohort 1 only: Proportion of subjects who achieve NASH/MASH resolution (defined as a NAS of 0–1 for inflammation and 0 for ballooning) as determined by the NASH CRN criteria at Week 96, Cohort 1 only: Proportion of subjects who achieve NASH/MASH resolution (defined as a NAS of 0–1 for inflammati | — |
Countries
France, Germany, Italy, Poland, Spain
Outcome results
None listed