MGL-3196 in Non-Alcoholic Steatohepatitis and Fibrosis

What is the Purpose of this Study?

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).


Eligibility

  • Must be willing to participate in the study and provide written informed consent.
  • Male and female adults ≥ 18 years of age.
  • Suspected or confirmed diagnosis of NASH fibrosis suggested by the historical data. Meet one of the following criteria that is consistent with NASH liver fibrosis:
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

III

IRB Number

STUDY00000287

ClinicalTrials.gov ID

NCT03900429

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

III

IRB Number

MGL-3196-11

ClinicalTrials.gov ID

NCT03900429

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org