Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH

Key Points

• To assess the efficacy and safety of the FGF21 analogue pegozafermin in patients with nonalcoholic steatohepatitis (NASH).
• Conducted a randomized, controlled phase 2b clinical trial (ENLIVEN; ClinicalTrials.gov number, NCT04929483) evaluating pegozafermin treatment.
• Treatment with pegozafermin resulted in improvements in fibrosis (numerical event rates, effect sizes, and p-values not reported in abstract).
• The observed therapeutic improvements support advancing pegozafermin into phase 3 clinical evaluation.