Inventiva reports last patient visit completed in NATiV3 Phase 3 lanifibranor trial

Inventiva announced on September 2, 2026 that the last patient in the NATiV3 Phase 3 clinical trial evaluating lanifibranor for treatment of patients with MASH with moderate and advanced fibrosis has completed their final 72-week visit.¹

The trial enrolled a substantial patient population. NATiV3 included 1,009 adults with biopsy-proven non-cirrhotic MASH and F2/F3 fibrosis, plus an additional 410 patients in an exploratory cohort.¹ With this last visit complete, all patients have now finished the 72-week treatment period.¹

The study design tested two dosing regimens. NATiV3 is structured as a randomized, double-blind, placebo-controlled trial assessing the long-term efficacy and safety of lanifibranor at 800mg and 1200mg daily doses in patients with the same biopsy-confirmed MASH and fibrosis criteria, measuring histological endpoints such as MASH resolution and at least one-stage improvement in fibrosis after 72 weeks.¹ Additionally, an exploratory cohort enrolled 410 patients with MASH spanning F1 through F4 fibrosis stages.¹

Patients had the option to continue further. Following the 72-week treatment period, participants could enter a 48-week open-label extension in which all patients, including those originally on placebo, receive active lanifibranor treatment, generating additional long-term safety data.¹

On timing, Inventiva reaffirmed it expects topline NATiV3 results in the fourth quarter of 2026, consistent with prior guidance.¹ Should those results be positive, the company said it plans to pursue regulatory submission in the first half of 2027 and is preparing for a possible U.S. launch of lanifibranor in 2028, contingent on FDA approval.¹

Separately, Inventiva also confirmed it will participate in several investor conferences during September 2026, and moved its first-half 2026 financial results date to Monday, September 28, 2026, revised from an earlier date of September 25.