Benzinga | Oct 28, 2021 07:15AM EDT

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

* 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.