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

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  • Inventiva (NASDAQ: 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 (NYSE: 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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