Inventiva Completes Last Patient Last Visit in Phase 3 NATiV3 Trial of Lanifibranor in MASH; Topline Data Expected Q4 2026 With NDA H1 2027
Inventiva SA (NASDAQ: IVA) announced Wednesday September 2, 2026 completion of the last patient's final 72-week visit in the Phase 3 NATiV3 study of lanifibranor (a pan-PPAR α/δ/γ agonist) in adults with biopsy-proven non-cirrhotic MASH and F2/F3 fibrosis. Enrollment: 1,009 patients in the main cohort plus an additional 410 patients in the exploratory cohort. NATiV3 assesses lanifibranor on histological endpoints including MASH resolution and improvement of fibrosis of at least one stage after 72 weeks of treatment. Inventiva expects to report topline data in Q4 2026 with NDA filing planned for H1 2027. Lanifibranor differentiates from the standard-of-care Madrigal Rezdiffra (resmetirom, THR-β agonist, approved March 2024) plus the emerging Boehringer Ingelheim survodutide, Novo Nordisk semaglutide MASH, and Akero Therapeutics efruxifermin (FGF21) programs by engaging three complementary PPAR isoforms in parallel to address steatosis, inflammation, and fibrosis.