
Inventiva, a clinical-stage biopharmaceutical company, has announced promising results from the LEGEND trial, which evaluated the combination of lanifibranor and empagliflozin for treating metabolic dysfunction-associated steatohepatitis (MASH) in patients with type-2 diabetes (T2D). These findings will be presented during an oral plenary session at the upcoming EASL Steatotic Liver Disease (SLD) Summit 2025 in Portugal.
The LEGEND trial, a Phase II multi-center, randomized, placebo-controlled study, assessed the safety and efficacy of lanifibranor (800mg/once daily) alone and in combination with empagliflozin, a SGLT2 inhibitor, over 24 weeks. The study achieved its primary endpoint by demonstrating a significant reduction in HbA1c levels in both active treatment groups compared to placebo. Additionally, secondary endpoints showed statistically significant improvements in liver injury markers, glucose and lipid metabolism, and hepatic steatosis.
Notably, the combination of lanifibranor and empagliflozin provided metabolic and liver health benefits without causing weight gain—a common concern in treatments for such conditions. The trial also confirmed the safety and tolerability of lanifibranor alone or in combination with empagliflozin, with no reported safety concerns.
This breakthrough highlights the potential of combining therapies to address the complex needs of patients with MASH and T2D. The LEGEND trial underscores Inventiva’s focus on advancing innovative oral therapies for diseases with significant unmet needs, particularly MASH, a chronic liver disease with no approved treatments.
Lanifibranor, Inventiva’s lead drug candidate, is also undergoing a pivotal Phase III trial (NATiV3) for MASH. The company continues to explore its robust pipeline, which includes preclinical programs and ongoing research in nuclear receptors and epigenetic modulation.
With these results, Inventiva is advancing the frontiers of metabolic and liver health treatments, offering hope for improved outcomes for patients with MASH and type-2 diabetes.