Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH

This phase 2b, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of pegozafermin, a long-acting FGF21 analogue, in 222 patients with biopsy confirmed noncirrhotic NASH and moderate to severe fibrosis (F2 or F3). Participants received subcutaneous pegozafermin (15 mg weekly, 30 mg weekly, or 44 mg every 2 weeks) or placebo for 24 weeks. The primary endpoints were fibrosis improvement (≥1 stage reduction without worsening of NASH) and NASH resolution without worsening of fibrosis. Results showed significant improvements in fibrosis with the 30 mg (26% vs. 7% placebo; P=0.009) and 44 mg (27% vs. 7%; P=0.008) doses. NASH resolution rates were also higher with pegozafermin (23–37% vs. 2% placebo). Adverse events included nausea and diarrhea. The study supports advancing pegozafermin to phase 3 trials for NASH treatment.

This phase 2b, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of pegozafermin, a long-acting FGF21 analogue, in 222 patients with biopsy confirmed noncirrhotic NASH and moderate to severe fibrosis (F2 or F3). Participants received subcutaneous pegozafermin (15 mg weekly, 30 mg weekly, or 44 mg every 2 weeks) or placebo for 24 weeks. The primary endpoints were fibrosis improvement (≥1 stage reduction without worsening of NASH) and NASH resolution without worsening of fibrosis. Results showed significant improvements in fibrosis with the 30 mg (26% vs. 7% placebo; P=0.009) and 44 mg (27% vs. 7%; P=0.008) doses. NASH resolution rates were also higher with pegozafermin (23–37% vs. 2% placebo). Adverse events included nausea and diarrhea. The study supports advancing pegozafermin to phase 3 trials for NASH treatment.