Madrigal Pharmaceuticals is conducting a Phase 2 clinical research study designed to examine the effect of the investigational drug MGL-3196 in patients with fatty liver disease, more specifically patients with Nonalcoholic Steatohepatitis (NASH), and some evidence of liver scarring, or liver fibrosis.
Fatty liver diseases or non-alcoholic fatty liver disease (NAFLD) is a common liver disease characterized by a buildup of fat in the liver. NAFLD tends to develop in people who are overweight or obese or have diabetes, high cholesterol or high triglycerides.
However, some people develop NAFLD even if they do not have any risk factors. NAFLD affects up to 25% of people in the United States.
Typically 3-5%, and in some studies up to 12%, of NAFLD patients may progress to non-alcoholic steatohepatitis (NASH). NASH is a liver disease that is associated with an increased amount of fat and inflammation in the liver. NASH can lead to a buildup of scar tissue in the liver called cirrhosis and increase the chances of getting heart disease. About 25% of NASH patients may develop liver-related disease or death. Frequently, NAFLD and even NASH have no symptoms, and people can have NASH for years before symptoms occur. No therapies have been approved for the treatment of NASH. For more information see American Liver Foundation article on NAFLD and NASH.
This Phase 2 study is to test the safety and effectiveness of the study drug called MGL-3196. MGL-3196 has previously been tested in humans and was well tolerated. MGL-3196 works by interacting with a form of thyroid hormone receptor in the liver thereby decreasing the amount of fat that has built up in the liver and potentially reducing the inflammation that is associated with NASH. MGL-3196 is an investigational drug. This means that it is still being studied and that it has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of NASH. The FDA only allows MGL-3196 to be used in research.
The purpose of this study is to determine:
- How well MGL-3196 works for the treatment of NASH compared to a placebo (a placebo looks like the study drug but does not contain any active ingredients).
- The safety of the study drug in participants with NASH.
About two thirds of patients in the study will be assigned to MGL-3196 and one third to placebo. Neither you nor your doctor will know the treatment assignment. The study lasts about 44 weeks.
You may be eligible to participate if you are likely to have NASH or have been diagnosed with NASH. In the first part of the study your study doctor will run some tests to determine if you have Nonalcoholic Steatohepatitis (NASH) and have some evidence of liver fibrosis.