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A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

Clinical Trial Details

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 (inactive ingredient) in men or women who have been diagnosed with Non-Alcoholic Steatohepatitis (NASH) or are suspected of having 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 three study groups to receive either 80 mg of MGL-3196, 100 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.
Study participation will last 4 ¾ years (57 months) and will require visits to the clinic. Participants will be compensated for their time.

Key Eligibility: 
  1. Men and women who are 18 to 75 years of age.
  2. Individuals who have been diagnosed with or are suspected of having NASH.

Detailed eligibility reviewed when contacting the study team


Study contact by location

Upper East Side - Manhattan


GI/ Hepatology
(646) 962-4040

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group