A Randomized, Controlled Trial of the Pan-PPAR Agonist Lan ifi branor in NASH

摘要

Methods:In this phase 2b,double-blind,randomized,placebo-controlled trial,patients with noncirrhotic,highly active NASH were randomly assigned in a 1:1:1 ratio to receive 1200 mg or 800 mg of lanifibranor or placebo once daily for 24 weeks.The primary end point was a decrease of at least 2 points in the SAF-A score(the activity part of the Steatosis,Activity,Fibrosis[SAF]scoring system that incorporates scores for ballooning and inflammation)without worsening of fibrosis;SAF-A scores range from 0 to 4,with higher scores indicating more-severe disease activity.Secondary end points included resolution of NASH and regression of fibrosis.