The NATIVE trial is a 24-week, placebo controlled, double blinded phase IIb study in patients with NASH. The purpose of this study is to evaluate the efficacy and the safety of two doses of lanifibranor (800mg, 1200 mg per day) for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis. The trial is open and recruiting patients.
The primary endpoint of the trial is a responder analysis based on the improvement of the SAF (steatosis/activity/fibrosis) activity score after 24 weeks. Responder is defined as a patient showing a decrease from baseline of at least 2 points of the SAF activity score combining hepatocellular inflammation and ballooning without worsening of fibrosis.
Who can participate in the NATIVE trial?
- Adults, age ≥18 years.
- NASH histological diagnosis requiring the combined presence of steatosis, lobular inflammation, liver cell ballooning, confirmed on a liver biopsy performed ≤ 6 months before. Patients will have to have a liver biopsy performed again after 24 weeks of treatment.
- SAF Activity score of 3 or 4 (>2), SAF Steatosis score ≥ 1, SAF Fibrosis score < 4
- Compensated liver disease
- No other causes of chronic liver disease
- If applicable, have a stable type 2 diabetes
- Have a stable weight since the liver biopsy was performed
- Negative pregnancy test or post-menopausal. Women with childbearing potential must be using a highly effective method of contraception.
Details of the trial, trial centers and inclusion/exclusion criteria can be found here. The recruitment of patients has been completed.