A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH.
Sven M FrancquePierre BedossaVlad RatziuQuentin M AnsteeElisabetta BugianesiArun J SanyalRohit LoombaStephen A HarrisonRozalina BalabanskaLyudmila MatevaNicolas LanthierNaim AlkhouriChristophe MorenoJörn Markus SchattenbergDiana Stefanova-PetrovaLuisa VonghiaRégine RouzierMaeva GuillaumeAlexander HodgeManuel Romero-GómezPhilippe Huot-MarchandMartine BaudinMarie-Paule RichardJean-Louis AbitbolPierre BroquaJean-Louis JunienManal F Abdelmaleknull nullPublished in: The New England journal of medicine (2021)
In this phase 2b trial involving patients with active NASH, the percentage of patients who had a decrease of at least 2 points in the SAF-A score without worsening of fibrosis was significantly higher with the 1200-mg dose of lanifibranor than with placebo. These findings support further assessment of lanifibranor in phase 3 trials. (Funded by Inventiva Pharma; NATIVE ClinicalTrials.gov number, NCT03008070.).