A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction Associated Steatohepatitis (MASH)

Research summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of pegozafermin for the treatment of Stage 2 or 3 liver fibrosis in adult subjects with NASH (Noncirrhotic Nonalcoholic Steatohepatitis). The study is designed to assess the efficacy and safety of 2 dose regimens of pegozafermin, administered either weekly (QW) or once every 2 weeks (Q2W) in subjects with biopsy-confirmed NASH (NAFLD activity score [NAS] ≥ 4, fibrosis stage F2 or F3 [NASH CRN system]). Approximately 840 subjects will be randomized 1:1:1 (pegozafermin 30 mg QW [n=280]: pegozafermin 44 mg Q2W [n=280]: placebo [n=280]). To maintain double dummy treatment design, approximately half of placebo subjects (n=140) will receive QW dosing, and the other half (n=140) will receive Q2W dosing. The study will consist of an up to 12-week screening period (which may be extended with Sponsor’s approval) and a 52-week double blind treatment period. The primary analysis of the study will be performed after all subjects complete 52 weeks of treatment. At the 52-week visit, subjects will be offered to continue their assigned treatment in a separate Clinical Outcomes study (Study Protocol BIO89-100-132), in which their participation will commence after completion of the 52 weeks assessments. The dose administered at the 52-week visit (after all assessments have been performed).

Principal Investigator

Dr Francesca Saffioti

Contact us

Email: ouh-tr.ctfresearch@nhs.net

IRAS number

1009791