Inventiva has announced screening of first participant in LEGEND Phase IIa combination trial of the company’s lead product candidate, lanifibranor, along with empagliflozin.

The orally available small molecule, lanifibranor activates all three-peroxisome proliferator-activated receptor (PPAR) isoforms in order to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body.

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The placebo-controlled, multi-centre, randomised, Phase IIa proof-of-concept study has been designed to evaluate the efficacy and safety of lanifibranor along with empagliflozin to treat non-cirrhotic non-alcoholic steatohepatitis (NASH) and type-2 diabetes (T2D) in adult patients.

The company stated that the trial is an open label for the combination of lanifibranor and the SGLT2 inhibitor empagliflozin arm and double-blind for the placebo and lanifibranor arms.

A total of 63 participants with non-cirrhotic NASH and T2D are expected to be recruited in the trial.

The non-cirrhotic NASH diagnosis in the trial will be based on a historic histology assessment or a combination of non-invasive techniques, such as imaging and serum-based metabolic diagnostic tests.

The company noted that the Phase IIa study will provide information regarding the evolution of body weight and body fat composition in NASH and T2D patients when treated with lanifibranor in combination with empagliflozin.

Inventiva chief medical officer Dr. Michael Cooreman said: “We are delighted to see the initiation of this Proof-of-Concept study, which we believe will further draw attention to NASH as a multisystemic liver disease with a highly relevant cardiometabolic aspect.

“This clinical trial is anticipated to not only add to the body of evidence demonstrating the therapeutic benefits of lanifibranor on the broad spectrum of the disease biology of NASH, but should also provide insights on how the complementary mechanisms of action of a pan-PPAR agonist and an SGLT2 inihibitor could enhance the therapeutic benefits of lanifibranor.”

Change in Hemoglobin A1c (HbA1c) at the end of the 24-week treatment will be the study’s primary efficacy endpoint.

Changes in body fat composition, liver enzymes, inflammatory markers, and glycaemic and lipids parameters will be some of the secondary endpoints of the study.

More than 30 sites the UK, Belgium, France, Netherlands, and the US have already been qualified to participate in the study.

The topline data from the trial are expected to be published in the second half of next year.