Madrigal (MGL-3196-11)

Condition: Nonalcoholic steatohepatitis (NASH), fibrosis

Eligibility

Key Inclusion Criteria:

  • At least 18 years old
  • Suspected or confirmed diagnosis of nonalcoholic steatohepatitis (NASH) fibrosis
  • Not pregnant or breastfeeding
     

Key Exclusion Criteria:

  • History of significant alcohol consumption for more than 3 consecutive months within 1 year prior to screening
  • Regular use of drugs historically associated with NAFLD
  • Thyroid diseases

Study Name

A Phase III, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation (IRB no. 00000287)

Summary

The purpose of this study is to evaluate the effects of an investigational drug called MGL-3196 on individuals with nonalcoholic steatohepatitis (NASH). Researchers aim to determine the safety, effectiveness and optimal dosage of MGL-3196, as well as whether treatment with MGL-3196 for several years will benefit participants.

MGL-3196 works together with a form of thyroid hormone receptor in the liver to decrease the amount of fat (in the liver) and possibly reduce the inflammation associated with NASH. Participants will be randomly assigned to 1 of 3 groups. The first group will receive 80mg MGL-3196; the second group will receive 100mg MGL-3196; and the third group will receive placebo (inactive substance).

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