About the Study
NATiV3 is a clinical trial for adults 18 years of age and older with NASH and liver fibrosis stage 2 or 3. The purpose of the trial is to evaluate if an oral investigational drug, called lanifibranor, is a safe and effective potential treatment option for NASH.
This clinical trial evaluates if there are any improvements in liver tissue such as reduction of scars (fibrosis) and/or other NASH lesions (such as fat or inflammation) that can impact how your liver works. This trial will also investigate if there is improvement in the way you feel after taking lanifibranor. It will also evaluate whether lanifibranor reduces the risk for liver transplant or other late-stage liver events, like cirrhosis in the long term.
Around 2,000 people throughout the world who have NASH with fibrosis will participate in the NATiV3 clinical trial.
Study Criteria
To qualify, participants must:
- Be 18 years of age or older
- Have been diagnosed with or be at risk for NASH with fibrosis
- Have stable body weight in the last 6 months
- Be willing to have a liver biopsy
Why Participate?
There is no cost to participate and health insurance is not required to participate. Participants will receive the investigational medicine (lanifibranor) or placebo at no cost, as well as regular health assessments and trial-related tests and procedures. If eligible, you will also be closely monitored for your NASH and related medical conditions during the trial and receive regular medical care from healthcare providers with experience in NASH. Reimbursement for travel expenses and compensation for your loss of time may be available.
