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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 Fibrosis

The 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.

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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 Site
Ottawa, Ontario
Canada

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Primary Contact

89bio Clinical Study Site

89bio Clinical Study Site
89bio Clinical Study Site
Vancouver, British Columbia
Canada

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89bio Clinical Study Site
89bio Clinical Study Site
Toronto, Ontario
Canada

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89bio Clinical Study Site
89bio Clinical Study Site
Toronto, Ontario
Canada

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Primary Contact

89bio Clinical Study Site

89bio Clinical Study Site
89bio Clinical Study Site
Calgary, Alberta
Canada

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Primary Contact

89bio Clinical Study Site

89bio Clinical Study Site
89bio Clinical Study Site
London, Ontario
Canada

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Primary Contact

89bio Clinical Study Site

89bio Clinical Study Site
89bio Clinical Study Site
Vaughan, Ontario
Canada

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Primary Contact

89bio Clinical Study Site

89bio Clinical Study Site
89bio Clinical Study Site
Vancouver, British Columbia
Canada

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Primary Contact

89bio Clinical Study Site

89bio Clinical Study Site
89bio Clinical Study Site
Winnipeg, Manitoba
Canada

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Primary Contact

89bio Clinical Study Site

Étude parrainée par
89bio, Inc.
Participants recherchés
Plus d'informations
ID de l'étude: NCT06318169