This study is evaluating the effects of Aramchol on the outcomes of patients with diabetes mellitus who have fatty liver disease. The main outcome to be measured will be the number of patients who have minimal to no symptoms of disease after treatment. This study is recruiting in Arlington, Texas, US.
The details
About 40 – 50% of patients with type 2 diabetes (T2D) also have non-alcoholic fatty liver disease (NASH). This disease is characterized by a build-up of fat in the liver. 20 – 30% of patients with fatty liver disease also have liver scarring (fibrosis), which can severely damage the liver. As scarring builds up over time, it can become irreversible (cirrhosis).
This study is evaluating the effects of Aramchol on the outcomes of patients with diabetes and fatty liver disease. The main outcome to be measured will be the number of patients who have minimal to no symptoms of liver disease or fibrosis after treatment.
Who are they looking for?
This study is looking for 2000 patients with T2D or prediabetes who have liver disease. Patients with T2D should have controlled blood glucose levels. Women must agree to use birth control during the study and for 1 month after the study.
Patients with advanced liver disease cannot participate. Patients with alcohol or drug addiction in the last five years cannot participate. Patients who had weight loss surgery in the last five years cannot participate. Patients who are on or planning to be on immunosuppressants cannot participate. Patients with uncontrolled high blood pressure cannot participate. Patients who have lost 5% or more weight within 3 months of study entry cannot participate.
How will it work
Patients will be divided into two groups. The first group will receive Aramchol twice a day, and the second group will receive a placebo (a substance with no active effect). Patients will be followed-up for 5 years.
The main outcome to be measured will be the number of patients who have minimal to no symptoms of liver disease or fibrosis after treatment. The number of patients who have a liver transplant and the number of patients who develop liver cirrhosis will also be measured.
