A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

To be considered for this study, you would first need to have a previous diagnosis of NASH confirmed by a liver biopsy. You might also have type 2 diabetes with a large waist circumference or obesity, or have fat in your liver shown on an ultrasound scan. Generally, you would need to be 18 years or older.

When you join the study, a new liver biopsy would confirm that you have NASH with specific levels of fat (Steatosis score of 1 or more), inflammation (Activity score 3 or 4), and moderate to severe scarring (Fibrosis F2 or F3). It's important that your dosage for certain regular medications, like some diabetes treatments or Vitamin E, hasn't changed for at least three to six months before the study starts. You should also have been a stable weight for six months prior to screening.

There are also some reasons why you wouldn't be able to join. These include having other types of chronic liver diseases besides NASH, having a more advanced stage of liver scarring (cirrhosis, F4), or a history of liver cancer. Severe changes in certain blood tests (like liver enzymes or haemoglobin) would also exclude you, as would being HIV positive or having had or planning a liver transplant.

If you decide to take part in this study, you will first go through a screening process to make sure you meet all the criteria. This will likely involve a physical exam, blood tests, and potentially a new liver biopsy. Once enrolled, you will be randomly assigned to either receive the study drug, lanifibranor, or a placebo (a dummy pill) for the first part of the study. You will take tablets regularly as instructed by the study team.

During this initial period and for the second, longer part where everyone receives the active drug, you will have regular visits to the clinic. These visits will involve various assessments such as physical examinations, blood and urine tests, heart trace (ECG) recordings, and potentially repeat liver biopsies or special scans to check your liver's health. You'll also be asked about your general well-being and any side effects you might be experiencing, which helps researchers monitor your safety.

The total duration of your participation in the study will depend on how long the researchers need to collect all the necessary information, especially during the second, longer treatment phase. The team will explain the exact schedule of visits and procedures when you consider joining.