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This study is being conducted to learn more about the effects and safety of the investigational/experimental study drug MGL-3196 (resmetirom) and compare the study drug with placebo in men or women who have been diagnosed with Non-Alcoholic Steatohepatitis (NASH).
An investigational/experimental study drug is one that has not been approved by the Food and Drug Administration (FDA).
NASH is a disease where fat, inflammation, and scar tissue build up in the liver. Having NASH increases the chances of developing heart disease. In time, liver cells may be so badly damaged that scar tissue forms (fibrosis) within the liver where healthy cells used to be. When this happens, doctors might diagnose this as “NASH fibrosis”. When enough scarring happens and the liver gets even more diseased, the liver becomes cirrhotic and stops working which causes serious complications in the body.
Participants will be randomized into one of two study groups to receive either 80 mg of MGL-3196 or placebo. Randomization is like flipping a coin and there is an equal chance of being assigned to each group. The placebo will look like the study drug but will not contain active medicine/ingredients.
This study requires participants to arrive at the clinic over a period of approximately 3 years and 3 months (39 months).
Study participants will be compensated for their time.
1. Men and women who are 18 years of age and older.
2. Individuals with been diagnosed with NASH.
Detailed eligibility reviewed when contacting the study team.