alcohol-related liver disease
Conditions
Brief summary
Change in Enhanced Liver Fibrosis (ELF)
Detailed description
Supportive secondary endpoints:, Change in Pro-peptide of Collagen 3 (Pro-C3), Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE), Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP), Change in Alanine Aminotransferase (ALT), Change in Aspartate Aminotransferase (AST), Supportive secondary endpoints to secondary objectives:, Number of treatment-emergent adverse events, Change in Phosphatidylethanol (PEth), Change in alcohol amount measured by timeline follow-back (TLFB), Change in total cholesterol
Interventions
DRUGcagrilintide
DRUGPlacebo (zalfermin) + Placebo
(semaglutide)
DRUGsemaglutide
DRUGPlacebo (cagrilintide) + placebo (semaglutide)
DRUGzalfermin
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Enhanced Liver Fibrosis (ELF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Supportive secondary endpoints:, Change in Pro-peptide of Collagen 3 (Pro-C3), Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE), Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP), Change in Alanine Aminotransferase (ALT), Change in Aspartate Aminotransferase (AST), Supportive secondary endpoints to secondary objectives:, Number of treatment-emergent adverse events, Change in Phosphatidylethanol (PEth), Change in alcohol amount measured by timeline follow-back (TLFB), Change in total cholesterol | — |
Countries
Bulgaria, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Spain
Outcome results
None listed