Non-alcoholic steatohepatitis (NASH)
Conditions
Brief summary
Improvement in liver fibrosis and no worsening of NASH (Yes/No) from baseline (week 0) to week 52
Detailed description
Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) from baseline (week 0) to week 52., Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No) from baseline (week 0) to week 52., Change in histology-assessed liver collagen proportionate area from baseline (week 0) to week 52., Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No) from baseline (week 0) to week 52., Improvement in liver fibrosis (Yes/No) from baseline (week 0) to week 52., Progression of liver fibrosis (Yes/No) from baseline (week 0) to week 52. For subjects with fibrosis stage 2 or 3 at baseline., Worsening in steatohepatitis (Yes/No) from baseline (week 0) to week 52., Improvement in ballooning (Yes/No) from baseline (week 0) to week 52., Improvement in inflammation (Yes/No) from baseline (week 0) to week 52., Improvement in steatosis (Yes/No) from baseline (week 0) to week 52., Change in ALT from baseline (week 0) to week 52., Change in AST from baseline (week 0) to week 52., Change in inflammation assessed by HsCRP from baseline (week 0) to week 52., Change in ELF score from baseline (week 0) to week 52., Change in HbA1c from baseline (week 0) to week 52. For subjects with type 2 diabetes., Change in triglycerides from baseline (week 0) to week 52., Change in free fatty acids from baseline (week 0) to week 52., Change in LDL cholesterol from baseline (week 0) to week 52., Change in HDL cholesterol from baseline (week 0) to week 52., Relative change in body weight from baseline (week 0) to week 52., Change in SF-36 bodily pain from baseline (week 0) to week 52., Change in NASH-CHECK pain from baseline (week 0) to week 52., Change in PROMIS Fatigue score from baseline (week 0) to week 52., Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to week 59.
Interventions
DRUGPlacebo C
DRUGSemaglutide B placebo PDS290 pen-injector
DRUGCagrilintide A 10 mg/mL cartridge
DRUGNNC0174-0833 A Placebo
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in liver fibrosis and no worsening of NASH (Yes/No) from baseline (week 0) to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) from baseline (week 0) to week 52., Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No) from baseline (week 0) to week 52., Change in histology-assessed liver collagen proportionate area from baseline (week 0) to week 52., Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No) from baseline (week 0) to week 52., Improvement in liver fibrosis (Yes/No) from baseline (week 0) to week 52., Progression of liver fibrosis (Yes/No) from baseline (week 0) to week 52. For subjects with fibrosis stage 2 or 3 at baseline., Worsening in steatohepatitis (Yes/No) from baseline (week 0) to week 52., Improvement in ballooning (Yes/No) from baseline (week 0) to week 52., Improvement in inflammation (Yes/No) from baseline (week 0) to week 52., Improvement in steatosis (Yes/No) from baseline (week 0) to week 52., Change in ALT from baseline (week 0) to week | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Italy, Poland, Portugal, Spain
Outcome results
None listed