Inventiva Reports the US FDA’s Acceptance of IND for Review of Lanifibranor and Empagliflozin for the Treatment of NASH and T2D
Shots:
- The US FDA has accepted the IND application to initiate the P-II (LEGEND) POC study to evaluate the safety & efficacy of lanifibranor + empagliflozin (SGLT2 inhibitor) in 63 patients with T2D & non-cirrhotic NASH. The trial is expected to be initiated in H1’22 & the results are expected in H2’23
- The primary efficacy of EPs is a change in HbA1c @24wk. treatment compared to baseline while 2EPs include changes in liver enzymes, glycaemic & lipids parameters, inflammatory markers & body fat composition
- The trial is designed to provide information on body weight evolution & body fat composition in patients with the same indication. Lanifibranor is being evaluated in the P-III (NATiV3) trial for NASH
Ref: Globe Newswire | Image: Inventiva
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