This study aims to examine the safety and effectiveness of new drug lanifibranorin patients with type 2 diabetes (T2D) and non-alcoholic fatty liver disease (NAFLD). The main outcome to be measured will be a change in intrahepatic triglyceride (amount of fats within the liver). This study is being conducted in the United States.
The details
T2D and NAFLD are closely related and often exist together. In T2D, the body loses the ability to control blood glucose levels. The liver is heavily involved in the control of blood glucose. Therefore, when there is a build-up of fat on the liver (like in NAFLD), the body finds it harder to control blood glucose. This can lead to the development of T2D. An ideal treatment for NAFLD would be to decrease the amount of fat build-up in the liver.
This study aims to examine the safety and effectiveness of the drug lanifibranor in patients with T2D and NAFLD. The main outcome to be measured will be a change in intrahepatic triglycerides (IHTG).
Who are they looking for?
This study is recruiting 74 patients. Patients must have a fasting blood glucose between 100 – 250 mg/dL and a HbA1c between 6-9.5%. Patients must have no new diabetic symptoms in the past 3 months. They also must be on a stable dose of their allowed diabetic medications for the past two months. Participants must have adequate kidney and liver function tests, as well as normal blood cell counts. Patients must not have any other cause of chronic liver disease other than NAFLD. Women of child-bearing age must be using a highly effective form of contraception.
Patients are excluded if they currently drink (or have in the past 6 months) 3 or more alcoholic drinks per day for men and 2 or more for women. Patients must not have had a weight change of greater than 5kg in the past 3 months or be on an anti-obesity drug. Patients must not be taking corticosteroids. Patients must not have been taking high-dose estrogens, methotrexate, tetracycline, amiodarone or blood thinners in the previous 6 months. Patients must not have any lung disease, organ transplantation, serious psychiatric diseases, claustrophobia, bone disease or cancer. Patients must not have active hepatitis B, C or HIV. Patients must not have any metallic implant that prevents MRI scanning.
How will it work
The will be two groups for this study. Patients will be randomly assigned to receive either 800mg/day of lanifibranor (tablets) or a placebo. Patients will be treated for 24 weeks. The study will last for 34-36 weeks in total. Imaging and blood tests will be carried out at the beginning. Patients will be followed up every 4 weeks. The test from the start of the study will be repeated after 24 weeks of treatment.
The main outcome to be measured is the change in IHTG. This will be done with a type of MRI scan called proton magnetic resonance and spectroscopy.
