In individuals with biopsy-confirmed nonalcoholic steatohepatitis (NASH) with fibrosis, the reductions in liver fat content (LFC) with efruxifermin correlated with improvements in markers of liver injury, fibrosis, metabolic parameters, and histologic features, according to updates from the phase IIa BALANCED study presented at ILC 2021.
A long-acting FGF21* analogue, once-weekly efruxifermin, irrespective of dose, has been shown to reduce LFC (as per MRI-PDFF**) vs placebo at 12 weeks in F1–F3 NASH patients. [Hepatology 2020;72;1S;6A] Eighty participants were randomized 1:1:1:1 to receive either efruxifermin 28, 50, or 70 mg, or placebo. Of these, 68 had available MRI-PDFF assessments at baseline and week 12 (n=50 achieved ≥30-percent relative LFC reduction at week 12 [MRI-PDFF responders]). Forty-two of the MRI-PDFF responders comprised the Biopsy Analysis Set (BAS; those with baseline and post-treatment biopsies). [Nat Med 2021;doi:10.1038/s41591-021-01425-3]
