A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis

  • STATUS
    Recruiting
  • End date
    Mar 16, 2024
  • participants needed
    2000
  • sponsor
    Madrigal Pharmaceuticals, Inc.
Updated on 17 July 2021
liver disease
cirrhosis
steatosis
fibrosis
hepatic fibrosis
fibroscan
mri-pdff
ballooning degeneration

Summary

A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

Details
Condition NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis
Treatment Placebo, MGL-3196
Clinical Study IdentifierNCT03900429
SponsorMadrigal Pharmaceuticals, Inc.
Last Modified on17 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Metabolic risk factors and AST > 20 U/L
Criteria consistent with liver fibrosis as defined as one of the following
Biochemical test for fibrosis OR
Fibroscan test OR
Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3
MRI-PDFF with increased fat fraction
Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24 weeks before anticipated date of randomization (if the biopsy is deemed acceptable for interpretation by the central reader) with fibrosis stage 1A, 1B, 2, or 3 on liver biopsy and NAS of 4 with a score of at least 1 in each of the following NAS
components
Steatosis (scored 0 to 3)
Ballooning degeneration (scored 0 to 2)
Lobular inflammation (scored 0 to 3)

Exclusion Criteria

History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening
Regular use of drugs historically associated with NAFLD
History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study
Recent significant weight gain or loss
HbA1c 9.0%
Glucagon-like peptide 1 [GLP-1] agonist , high dose Vitamin E (> 400 IU/day) or pioglitazone therapy unless stable dose for 24 weeks prior to biopsy
Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis
Diagnosis of hepatocellular carcinoma (HCC)
MELD score 12, as determined at Screening, unless due to therapeutic anti coagulation
Hepatic decompensation
Chronic liver diseases other than NASH
Active autoimmune disease
Serum ALT > 250 U/L
Active, serious medical disease with a likely life expectancy < 2 years
Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer
Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes
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