StoryTest
Inventiva completes enrollment of its 1,009-patient phase 3 NATiV3 trial of lanifibranor in MASH
Inventiva finished randomising patients into NATiV3, the phase 3 trial of its daily pan-PPAR pill in MASH with moderate to advanced liver scarring. The main cohort beat its target of 969 with 1,009 patients, and an exploratory cohort added 410. The trial tests two doses against placebo for 72 weeks, with biopsy-based endpoints.
- Main cohort 1,009 (target 969); exploratory cohort 410 (target 350).
- Doses: 800 mg and 1,200 mg once daily vs placebo.
- Endpoints: MASH resolution and at least one-stage fibrosis improvement after 72 weeks.
- Lanifibranor holds FDA Breakthrough Therapy and Fast Track designations.