NATIiV3 Study for NASH and Stage 3 Liver Fibrosis

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A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

Sex at Birth: Any
Age: Adult (18 - 64), Older Adult (65+)
Accepting Healthy People: No
Type: Interventional / Therapeutic
Trial Phase: Phase III
Conditions Being Studied: Liver, Nonalcoholic Fatty Liver Disease

Study Purpose

NASH is a liver disease associated with inflammation and liver cell injury visible under a microscope with a liver biopsy. This condition may lead to advanced scarring of the liver called fibrosis and cirrhosis and deserves serious medical management. The study has 2 main goals: 1. Evaluate if the study medication improves your liver tissue scars (fibrosis) and resolves NASH. This is assessed by a biopsy of your liver that will be done after 72 weeks of treatment. 2. Evaluate on the long term if the study medication can delay the complications that can ultimately damage the liver function (NASH disease progression). You will continue the same treatment until the study collects enough information, without exceeding 7 years, and a final liver biopsy will be done.