The purpose of this research is to determine whether an investigational drug (a drug that has not been approved by the Food and Drug Administration [FDA] for use outside of research studies) known as MET642 is safe and effective in the treatment for NASH. MET642 is in a class of drugs called an FXR agonist, which means it binds to and activates a protein called FXR. FXR (farnesoid X receptor) is in the liver and intestine where it plays an important role in many metabolic functions, such as carbohydrate and fat breakdown, and bile acid synthesis (a process in cells of the body where cholesterol is converted into bile acids). By activating FXR, the inflammation and the build-up of fat in the liver may be reduced in people with NASH.
The purpose of this study is to learn about the effects of a study drug, MET642, to find the best dose for treating NASH, and to see how safe the MET642 is for participants with NASH. In this study, MET642 will be compared to placebo. A placebo looks like the study drug but does not contain any medication (active ingredient). Researchers use a placebo to see if a study drug works better or is safer than not taking anything at all.
This is a double-blind, placebo-controlled, multi-center assessment of two dose levels of MET642 or placebo for 16 weeks (112 days). Approximately 180 subjects will be randomized to one of 3 treatment arms in a 1:1:1 ratio: MET642 6 mg, MET642 3 mg, or matching placebo. You will need to take the study drug once daily. You will receive your first dose of study drug on Day 1 of the Study Treatment Period. You will need to return to the study site on Day 14, Day 28, Day 56, Day 84 and Day 112 for study assessments. You will need to fast (no food or drink except water) overnight prior to your study visits.
- Male or female between the ages of 18 and 75
- Diagnosed with NASH (nonalcoholic steatohepatitis
Study Participants may receive:
- Up to 15 visits
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