A randomised double-blind placebo-controlled multicentre Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis | NYU Langone Health

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A randomised double-blind placebo-controlled multicentre Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Nonalcoholic Steatohepatitis (nash)
Age: Between 18 Year(s) - 100 Year(s)
Gender: Male or Female

Other Inclusion Criteria:
1. If biopsy performed before screening, histological diagnosis of NASH with liver fibrosis made no more than 6 months before screening
2. The patient will be willing to continue on the study in case of moving or relocation during the first 72 weeks of the study.
3. Patient agrees to follow recommendations with lifestyle modifications, which will be monitored throughout the whole study period.

You may not be eligible for this study if the following are true:

1. Documented causes of chronic liver disease other than NASH including, but not restricted to:
  - Drug-induced liver disease
  - Autoimmune hepatitis
  - Wilson’s disease
  - Haemochromatosis
  - Primary biliary cholangitis
  - Primary sclerosing cholangitis
  - Alpha-1-antitrypsin deficiency
  - Chronic portal vein thrombosis or splenic vein thrombosis
2. History or current diagnosis of hepatocellular carcinoma (HCC)
3. History of or planned liver transplant
4. Positive human immunodeficiency virus (HIV) serology
5. Diabetes mellitus other than type 2 (e.g. type 1, endocrinopathy, and genetic syndromes)
6. Current treatment with insulin
7. Women currently breastfeeding