Have you been diagnosed with Non-alcoholic Steatohepatitis (NASH)?
The NATiV3 trial may be an option for you.
NASH is a silent and progressive liver disease affecting 1 in 10 adults in the United States. Currently, there is no approved pharmaceutical treatment for the disease.
Be part of developing a new NASH treatment.
Have you been diagnosed with Non-alcoholic Steatohepatitis (NASH)?
The NATiV3 trial may be an option for you.
NASH is a silent and progressive liver disease affecting 1 in 10 adults in the United States. Currently, there is no approved pharmaceutical treatment for the disease.
Be part of developing a new NASH treatment.
About NATiV3, a Phase 3 Clinical trial in 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. In addition, the trial will evaluate whether lanifibranor reduces the risk for liver transplant or other late-stage liver events, like cirrhosis in the long term.
Around 1,000 people throughout the world who have NASH with fibrosis will participate in the NATiV3 clinical trial.
About lanifibranor
The investigational drug in the NATiV3 trial is called lanifibranor. Lanifibranor is a small molecule and is a drug that is taken orally once a day. Lanifibranor is designed to work by targeting your liver. It may help repair liver damage and control cardiovascular risk factors by decreasing inflammation and reducing fat and sugar in the blood. Lanifibranor has been studied in over 500 healthy volunteers and patients with metabolic and liver diseases and has shown good safety results. More research like this NATiV3 clinical trial is needed to learn more about lanifibranor and the treatment of patients with NASH with fibrosis.
Lanifibranor is called an investigational drug because it is currently being evaluated in clinical trials. The results from previous trials and NATiV3 will be used for possible future approvals of Lanifibranor as a treatment for NASH, including in the United States by the Food and Drug Administration (FDA).
Although NASH affects a growing number of people, there is still no approved treatment for the condition. There is an urgent need to develop treatment options for patients with NASH and clinical research is essential to this process. This clinical trial is an important step in that process.
What will happen during the trial
If you are eligible and choose to participate in the NATiV3 clinical trial, you will:
Receive lanifibranor (if you are randomly assigned to the investigational drug group (800mg/day or 1200mg/day) or receive a placebo (if you are randomly assigned to the placebo group) in the first part of the trial for 72 weeks or up to maximum 120 weeks. In the second part of the trial which will last 48 weeks, you will receive lanifibranor, even if you were randomly assigned to the placebo group in the first past of the trial. This second part of the trial does not have a placebo group anymore
Receive regular health assessments and trial-related tests and procedures
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
In the first part of this trial, each participant will be selected at random to receive either lanifibranor or the placebo. Neither the participants nor the study staff will know whether a participant is receiving lanifibranor or placebo.
If you are randomly selected to receive the placebo, you will still receive the complete range of medical care and health assessments. The clinical study team will at your side and available any time during the entire duration of the study. For the second part of the trial (48 weeks), all patients will only receive lanifibranor.
The participation of patients to clinical trials is crucial to advancing new medications to treat liver disease. We are thankful for your consideration. If you have any questions about your participation in clinical trials, contact your physician for further guidance.
Learn more
The links below provide additional information about liver function, NASH, clinical trials, and other organizations that work to promote education, treatment, and research options for liver disease.
Patient Advocacy Groups
