Inventiva announced the design of a proof-of-concept Phase IIa combination trial with its lead drug candidate lanifibranor and the SGLT2 inhibitor empagliflozin in patients with T2D and non-cirrhotic NASH. LEGEND (Lanifibranor in combination with the SGLT2 inhibitor empagliflozin in patients with NASH and type 2 diabetes) trial has been designed as a multi-center randomized, placebo-controlled proof-of-concept Phase IIa trial to assess the safety and efficacy of lanifibranor in combination with the SGLT2 inhibitor empagliflozin for the treatment of patients with non-cirrhotic NASH and T2D. The trial is double-blind for the placebo and lanifibranor arms and open-label for the combination of lanifibranor and empagliflozin arm. The primary efficacy endpoint of the trial is a change in Hemoglobin A1c (HbA1c) at the end of the 24-week treatment compared to baseline. Secondary endpoints include changes in liver enzymes, glycaemic and lipids parameters, inflammatory markers and body fat composition. The trial is designed to provide valuable information on body weight evolution and body fat composition in patients with NASH and T2D when treated with lanifibranor and empagliflozin. Magnetic resonance imaging (MRI) will in addition allow to collect non-invasive data on hepatic fat, inflammation and fibrosis. A total of 63 patients with non-cirrhotic NASH and T2D will be randomized into the trial, in several sites in the United States and Europe. The diagnosis of non-cirrhotic NASH will be based on historic histology evaluation or a combination of non-invasive methods including imaging and serum-based metabolic diagnostic tests (?probable NASH?). The initiation of the trial is planned for the first half of 2022 and the publication of top line results is expected for the second half of 2023.