Commentary
Treatment options for NASH are limited. S. M. Francque et al. (Antwerp University Hospital, Belgium) examined the effects of lanifibranor, a pan-agonist of the peroxisome proliferator–activated receptors with favourable effects on glucose and lipid metabolism, inflammation, and fibrosis, in 247 patients with active, noncirrhotic NASH.
In this phase 2b, double-blind, randomized, placebo-controlled trial, 247 patients with noncirrhotic, highly active NASH were randomly assigned to receive 1200 mg or 800 mg of lanifibranor or placebo once daily for 24 weeks. The primary endpoint was a decrease of at least 2 points in the SAF-A score without worsening of fibrosis. Secondary endpoints included resolution of NASH and regression of fibrosis.
At 24 weeks, the proportion of patients with a ≥2-point decrease in this score and no increase in fibrosis was significantly higher with a 1200-mg dose of lanifibranor than with placebo (55% vs. 33%). Liver enzyme levels decreased and the levels of the majority of lipid, inflammatory, and fibrosis biomarkers
