Fibrosis, Metabolic Dysfunction-Associated Steatohepatitis (MASH), Non Alcoholic Steatohepatitis (NASH)
Conditions
Brief summary
The primary histology endpoint will be the proportion of subjects in Cohort 1 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 Clinical Research Network [CRN] fibrosis score) at Week 52., The primary clinical outcomes endpoint 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.
Detailed description
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 no worsening of fibrosis (based on NASH CRN fibrosis score) at Week 52., Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis (defined as no increase in NAS for ballooning, inflammation, or steatosis) at Week 52., 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, AST, gamma-glutamyl transferase (GGT), and uric acid, Change from baseline total cholesterol, TG, high density lipoprotein cholesterol (HDL-C), non-HDL—C, and low-density lipoprotein cholesterol (LDL-C), Change from baseline in HbA1c and adiponectin, Change from baseline in body weight., Safety and tolerability will be assessed through the reporting of extent of exposure, AEs, and clinical assessments., Immunogenicity will be assessed through the detection and measurement of ADA, including NAb, against EFX.
Interventions
Sponsors
Akero Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary histology endpoint will be the proportion of subjects in Cohort 1 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 Clinical Research Network [CRN] fibrosis score) at Week 52., The primary clinical outcomes endpoint 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 no worsening of fibrosis (based on NASH CRN fibrosis score) at Week 52., Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis (defined as no increase in NAS for ballooning, inflammation, or steatosis) at Week 52., 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, AST, gamma-glutamyl transferase (GGT), and uric acid, Change from baseline total cholesterol, TG, high density lipoprotein cholesterol (HDL-C), non-HDL—C, and low-density lipoprotein cholesterol (LDL-C), Change from baseline in HbA1c and adiponectin, Change fr | — |
Countries
France, Germany, Italy, Poland, Spain
Outcome results
None listed