A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With FibrosisThe study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
null
Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
18 to 80
Critères de participation
Key Inclusion Criteria:
* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
* Biopsy-confirmed MASH with fibrosis stage F2 or F3
* Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants).
Key Exclusion Criteria:
* Chronic liver diseases other than MASH
* Evidence of cirrhosis on screening liver biopsy
* Have type 1 diabetes or poorly controlled type 2 diabetes
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
* Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening
Other inclusion and exclusion criteria may apply.
Lieu de l'étude
89bio Clinical Study Site
89bio Clinical Study SiteOttawa, Ontario
Canada
Contactez l'équipe d'étude
89bio Clinical Study Site
89bio Clinical Study Site
89bio Clinical Study SiteVancouver, British Columbia
Canada
Contactez l'équipe d'étude
89bio Clinical Study Site
89bio Clinical Study SiteToronto, Ontario
Canada
Contactez l'équipe d'étude
89bio Clinical Study Site
89bio Clinical Study SiteToronto, Ontario
Canada
Contactez l'équipe d'étude
89bio Clinical Study Site
89bio Clinical Study Site
89bio Clinical Study SiteCalgary, Alberta
Canada
Contactez l'équipe d'étude
89bio Clinical Study Site
89bio Clinical Study Site
89bio Clinical Study SiteLondon, Ontario
Canada
Contactez l'équipe d'étude
89bio Clinical Study Site
89bio Clinical Study Site
89bio Clinical Study SiteVaughan, Ontario
Canada
Contactez l'équipe d'étude
89bio Clinical Study Site
89bio Clinical Study Site
89bio Clinical Study SiteVancouver, British Columbia
Canada
Contactez l'équipe d'étude
89bio Clinical Study Site
89bio Clinical Study Site
89bio Clinical Study SiteWinnipeg, Manitoba
Canada
Contactez l'équipe d'étude
89bio Clinical Study Site
- Étude parrainée par
- 89bio, Inc.
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06318169