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
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
18 Years and up
Accepting Healthy Volunteers?
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
1. Metabolic risk factors and AST > 20 U/L
2. Criteria consistent with liver fibrosis: fibrosis biomarkers or fibroscan or historical liver biopsy with NASH andstage 2 or 3 fibrosis
- Biochemical test for fibrosis
- Historical liver biopsy with NASH and Stage 2 or 3 Fibrosis
4. MRI-PDFF with increased fat fraction
5. 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:
1. Steatosis (scored 0 to 3)
2. Ballooning degeneration (scored 0 to 2)
3. Lobular inflammation (scored 0 to 3)
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.