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Inventiva 337HNAS20011 (NATiV3): 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 steatoh

Clinical Trial Details

This study is for men and women who have been diagnosed with non-cirrhotic nonalcoholic Steatohepatitis (NASH) and liver fibrosis. This study will test the experimental/investigational drug named lanifibranor to help in the treatment of non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis (the amount of scarring), and how safe it is to use in people.

The investigational drug lanifibranor has not been approved by the U.S. Food and Drug Administration (FDA) in the United States for the treatment of non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis (the amount of scarring).

Participatants will be randomized (assigned by chance like the flip of a coin) to one of the following study groups:

  • Group A: Lanifibranor 800mg per day
  • Group B: Lanifibranor 1200mg per day
  • Group C: Matching placebo

The placebo tablet will look like lanifibranor but will not contain active medicine/ingredients.

Total study participation will last about 5 to 7 years depending on when participation begins and participants will be compensated for their time. 

Key Eligibility: 
  1. Men and women who are 18 years of age and older.
  2. Have been diagnosed with non-cirrhotic Nonalcoholic Steatohepatitis (NASH) and liver fibrosis.

Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2202024401

ClinicalTrials.gov:

NCT04849728

Sponsor:

Inventiva 337HNAS20011 (NATiV3)

Status

Open to Enrollment

Age Group

Adult

Sponsor