Inventiva Plans To Start Lanifibranor Combo Study In NASH, Diabetes In 2022

  • Inventiva IVA announced the design of Phase 2a combination trial of lanifibranor in patients with type 2 diabetes (T2D) and non-cirrhotic non-alcoholic steatohepatitis (NASH).
  • The trial will assess lanifibranor combined with Eli Lilly And Co's LLY Jardiance (empagliflozin).
  • The trial's primary efficacy endpoint 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. 
  • 63 patients with non-cirrhotic NASH and T2D will be randomized into the trial. 
  • The Company plans to initiate the trial in 1H of 2022, with top-line results in 2H of 2023.
  • Related: Fast Track Status Expanded For Inventiva's NASH Treatment.
  • Price Action: IVA shares closed at $15 on Wednesday.
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