Condition

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Non-alcoholic Steatohepatitis (NASH)  

Purpose of the study

The 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]).

Official Title

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis.    NCT06318169

Who is eligible to participate?

Inclusion Criteria

• At least 1 metabolic risk factor.
• Biopsy-confirmed MASH with fibrosis stage F2 or F3 per NASH clinical research network (CRN) system and NAS ≥4, with a score at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation or NAS <4 and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of at least 1 in steatosis. A historical biopsy must be within 6 months of screening visit.
• Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and <50.0 kilograms (kg)/meters squared (m^2). Exclusion Criteria Chronic liver diseases other than MASH/NASH. Evidence of cirrhosis on screening liver biopsy Have type 1 diabetes or poorly controlled type 2 diabetes Participants taking Vitamin E (>400 IU/day) or pioglitazone must be on stable dose for at least 6 months prior to screening.

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane