Inventiva Completes Enrollment In Phase 3 Trial For MASH Drug; Topline Results Expected In 2026

Inventiva has completed patient enrollment for its Phase 3 NATiV3 trial, which is evaluating lanifibranor as a treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH). The trial exceeded its initial enrollment targets, with 1,009 patients in the primary cohort and 410 patients in the exploratory cohort. This milestone is crucial for progressing toward regulatory approval, as the trial aims to assess the drug’s efficacy in non-cirrhotic MASH patients with F2/F3 fibrosis over 72 weeks.

Frederic Cren, CEO and co-founder of Inventiva, commented, “The completion of enrollment of NATiV3 marks a significant milestone in the development of lanifibranor. With topline results expected in the second half of 2026, lanifibranor could be the next oral therapy approved for treating patients with MASH. On behalf of the entire Inventiva team, I would like to express our deepest gratitude to the patients, investigators and staff at clinical trial sites participating in the NATiV3 trial worldwide, our partners and collaborators whose commitment has made it possible to reach this major milestone. I would also like to thank the Inventiva team, which has dedicated themselves to achieving this critical milestone.”

NATiV3 trial is a critical element of Inventiva’s €348 million financing plan, enabling access to the second €116 million payment. The financial agreement with the third patient required the approval of the last subject in the study by April 30, 2025, and less than a 30% drop-out rate at week 72. The exploratory cohort delivers supplemental non-invasive tests that supplement the regulatory safety information required for future approval submissions. 

Prof. Arun Sanyal, M.D., Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University and co-principal investigator of NATiV3, said in a statement, “The compelling data from the NATIVE Phase 2b trial of lanifibranor after just six months of treatment, instil strong confidence in the potential of lanifibranor to become a cornerstone therapy for patients with MASH if approved. The unmet medical need for patients with MASH is significant, and lanifibranor’s unique mechanism of action could offer a tailored and promising potential solution, particularly for patients with advanced fibrosis and type 2 diabetes. I am eager to see the topline results and look forward to collaborating closely with Inventiva to ensure a successful NDA filing.”

The regulatory pathway for lanifibranor will advance through Phase 3 topline results, which Inventiva expects during the second half of 2026. The twice-daily dose of the drug has two options, 800 mg or 1200 mg, for testing in MASH resolution and fibrosis improvement. The exploratory cohort data will improve regulatory submission by demonstrating lanifibranor's ability to become a breakthrough therapy for MASH patients.