N Engl J Med

EASL 2025: Investigational drug didn’t reduce fibrosis in patients with MASH cirrhosis

May 13, 2025

In patients with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), efruxifermin didn’t significantly reduce fibrosis at 36 weeks. These findings were presented at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam.

Study details: The phase 2b SYMMETRY trial (NCT05039450) evaluated the efficacy and safety of efruxifermin, a bivalent fibroblast growth factor 21 (FGF21) analogue, in 181 patients with biopsy-confirmed compensated cirrhosis (stage 4 fibrosis) due to MASH. Patients were randomized to receive SC efruxifermin at doses of 28 mg or 50 mg once daily, or placebo. The primary outcome was a reduction of ≥1 stage of fibrosis without worsening of MASH at 36 weeks, with secondary outcomes assessed at 96 weeks.

Results: At 36 weeks, fibrosis reduction without worsening of MASH was observed in 13% of the placebo group, 18% of the 28-mg efruxifermin group (P=0.62), and 19% of the 50-mg efruxifermin group (P=0.52), with no statistically significant differences. At 96 weeks, the respective rates were 11%, 21%, and 29%, with the 50-mg group showing a significant improvement over placebo (difference 16 percentage points; 95% CI, 2 - 30). GI adverse events were more common in the efruxifermin groups but were mostly mild or moderate.

Source:

Noureddin M, et al. (2025, May 9). N Engl J Med. Efruxifermin in Compensated Liver Cirrhosis Caused by MASH. https://pubmed.ncbi.nlm.nih.gov/40341827/