Met 409

Met 409


The purpose of this research is to determine whether an investigational drug (a drug that has not yet been approved by the Food and Drug Administration [FDA] for use outside of research studies) known as MET409 will improve the treatment of liver fat and liver scarring (fibrosis) in patients diagnosed with nonalcoholic steatohepatitis (NASH) that also have Type 2 Diabetes Mellitus (T2DM) with or without the addition of empagliflozin (Jardiance®). Empagliflozin (Jardiance®) is an oral FDA approved drug to improve glycemic control in adults with type 2 diabetes mellitus.

MET409 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) exists in the liver and intestine where it plays an important role in various 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.

The specific purposes of this study are to: Find out what, if any, side effects (good and bad) MET409 has on your body with or without empagliflozin. Find out how fast and how completely the investigational study drug is absorbed into the body, the maximum amount (concentration in blood) in the body, and how rapidly the investigational study drug is eliminated from the body. Evaluate any proof of activity of MET409 for management of NASH in subjects also diagnosed with T2DM with or without empagliflozin. Help determine the best dose of MET409 that is to be given to subjects with NASH that also have T2DM with or without empagliflozin.

There are 3 stages to this study: Screening (visit + MRI on separate date), Study Treatment Period (which consists of 5 outpatient visits & 2 MRI visits), and Follow-Up Period (which consists of 1 outpatient visit & 1 MRI visit).

You may qualify if you are:
  • Male or Female:
    • Between the ages of 18 and 75
    • Diagnosed with Type 2 Diabetes
    • Diagnosed with NASH
    • HbA1c lower than or equal to 10%

Study Participants may receive:

  • Compensation of up to $1,714 if all visits are completed
  • Travel reimbursement

Study Details

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