Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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

Official Title

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

Keywords

NASH - Nonalcoholic Steatohepatitis Fatty Liver Non-alcoholic Fatty Liver Disease MGL-3196

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Must be willing to participate in the study and provide written informed consent.
  2. Male and female adults ≥ 18 years of age.
  3. Suspected or confirmed diagnosis of NASH
  4. Metabolic risk factors and AST > 20 U/L
  5. Criteria consistent with liver fibrosis as defined as one of the following:
  6. Biochemical test for fibrosis OR
  7. Fibroscan test OR
  8. Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3
  9. MRI-PDFF with increased fat fraction
  10. 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:
  11. Steatosis (scored 0 to 3)
  12. Ballooning degeneration (scored 0 to 2)
  13. Lobular inflammation (scored 0 to 3)

You CAN'T join if...

  1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
  2. Regular use of drugs historically associated with NAFLD
  3. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
  4. Recent significant weight gain or loss
  5. HbA1c ≥ 9.0%.
  6. 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.
  7. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
  8. Diagnosis of hepatocellular carcinoma (HCC).
  9. MELD score ≥12, as determined at Screening, unless due to therapeutic anti coagulation.
  10. . Hepatic decompensation
  11. . Chronic liver diseases other than NASH
  12. . Active autoimmune disease
  13. . Serum ALT > 250 U/L.
  14. . Active, serious medical disease with a likely life expectancy < 2 years.
  15. . Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer.
  16. . 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.

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States
  • Alliance Clinical Research accepting new patients
    Poway California 92064 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Madrigal Pharmaceuticals, Inc.
ID
NCT03900429
Phase
Phase 3
Study Type
Interventional
Last Updated