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 for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 to 75
Participation Criteria
Key Inclusion Criteria:
* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF)
* Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation (qualifying biopsy must be either within 6 months of screening visit \[with additional requirements\] or obtained during screening period)
* Body mass index (BMI) at screening ≥25.0 (≥23 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2)
Key Exclusion Criteria:
* Chronic liver diseases other than MASH/NASH
* History or 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) must be on stable dose for at least 6 months prior to screening
Other inclusion and exclusion criteria may apply.
Study Location
89bio Clinical Study Site
89bio Clinical Study SiteOttawa, Ontario
Canada
Contact Study Team
89bio Clinical Study Site
89bio Clinical Study Site
89bio Clinical Study SiteVancouver, British Columbia
Canada
Contact Study Team
89bio Clinical Study Site
89bio Clinical Study Site
89bio Clinical Study SiteToronto, Ontario
Canada
Contact Study Team
89bio Clinical Study Site
- Study Sponsored By
- 89bio, Inc.
- Participants Required
- More Information
- Study ID:
NCT06318169