Inventiva Announces Full Enrollment in Phase 3 NATiV3 Trial for Lanifibranor in Patients with MASH and Advanced Fibrosis

Inventiva Announces Completion of Patient Enrollment in NATiV3 Phase 3 Clinical Trial

Daix, France and New York City, NY, USA – April 1, 2025 – Inventiva, a clinical-stage biopharmaceutical company specializing in the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and other diseases with significant unmet medical needs, made an exciting announcement today. The company has completed patient enrollment in its NATiV3 Phase 3 clinical trial, having randomized the last patient in the main cohort.

Inventiva’s NATiV3 trial is a pivotal study designed to evaluate the efficacy and safety of its lead compound, odalasparanib, in patients with NASH (non-alcoholic steatohepatitis), a severe form of MASH. The trial enrolled 1,419 patients in total – 1,009 in the main cohort and 410 in the exploratory cohort.

Exceeding Original Targets

The company initially aimed to enroll 969 patients in the main cohort and 350 in the exploratory cohort. However, the strong interest and demand for the trial led to the enrollment of 1009 patients in the main cohort and 410 patients in the exploratory cohort, surpassing the original targets.

Impact on Patients

For individuals diagnosed with NASH, this development brings hope for a potential new treatment option. NASH is a chronic liver condition that affects millions of people worldwide, often leading to cirrhosis, liver failure, and even cancer. Current treatments are limited, and many patients do not respond well to them or experience side effects. Odalasparanib, if proven effective and safe in the NATiV3 trial, could provide a much-needed alternative for patients.

Global Implications

The successful completion of patient enrollment in the NATiV3 Phase 3 clinical trial is not just a victory for Inventiva but also for the global community. NASH is a growing health concern, and its prevalence is expected to continue increasing as obesity and diabetes rates rise. The development of an effective and safe treatment for NASH could significantly improve the lives of millions of people and reduce the burden on healthcare systems.

Conclusion

Inventiva’s announcement of the completion of patient enrollment in its NATiV3 Phase 3 clinical trial marks an important milestone in the quest for a new treatment for NASH. With the randomization of the last patient in the main cohort, the trial is now fully underway, and the results are eagerly anticipated. The potential impact on patients and the global community is significant, and the success of the trial could pave the way for a new era in the treatment of NASH and other metabolic diseases.

  • Inventiva completes patient enrollment in NATiV3 Phase 3 clinical trial for NASH treatment
  • 1,419 patients enrolled in total, surpassing initial targets
  • Odalasparanib, Inventiva’s lead compound, could provide a much-needed alternative for NASH patients
  • Successful trial results could significantly improve lives of millions and reduce healthcare burden

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