Inventiva has reported positive topline findings from a Phase II trial of lanifibranor to treat patients with nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2D).

During the trial, 38 patients were randomised into two arms to treat them with either a placebo or 800mg of lanifibranor per day for 24 weeks.

Results showed that the trial achieved its primary efficacy endpoint, with a 44% decrease of intrahepatic triglycerides (IHTG) measured with the help of proton magnetic resonance spectroscopy (1H-MRS) in NAFLD and T2D patients who received lanifibranor, against 12% in the placebo arm.

They also showed a statistically important higher proportion of patients achieving a liver triglyceride reduction of more than 30%, and NAFLD resolution with lanifibranor, in comparison with a placebo.

In addition, the study showed a significant impact on various secondary endpoints such as glycemic control, atherogenic dyslipidemia, hepatic insulin action, insulin-stimulated muscle glucose disposal, and amelioration of the adipose tissue dysfunction, with an increase in plasma adiponectin.

It was also found that treatment with 800mg of lanifibranor per day for 24 weeks was well tolerated.  No safety concerns were observed during the trial.

Inventiva expects to provide additional secondary endpoints, including multiple cardiometabolic health markers, in future scientific conferences and publications.

University of Florida Department of Medicine Division of Endocrinology, Diabetes and Metabolism professor and the trial’s principal investigator Dr Kenneth Cusi said: “This is an important study for a drug that has already shown promising results in patients with NASH.

“Lanifibranor is an insulin-sensitiser, with demonstrated effects to reverse steatohepatitis and fibrosis.

“The positive results of our study on hepatic fat and liver and muscle insulin sensitivity, as well as fat metabolism, within just 24 weeks of treatment confirm the robustness of the mechanism of action of lanifibranor in key tissues, and its potential to manage patients with T2D, but also patients with pre-diabetes and obesity.”