Protocol Summary

Protocol No.: OCR21842

Sponsor Protocol No.: MGL-3196-11

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

Principal Investigator: Firpi-Morell, Roberto

Objective: 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

Phase: Phase III

Age Group: Adult

Age: 18 Years - N/A

Gender: All

Treatment:

Placebo Comparator: Matching Placebo
Placebo Daily

Active Comparator: 80 mg MGL-3196
80 mg daily

Active Comparator: 100 mg MGL-3196
100 mg daily

Detailed Eligibility:

Inclusion Criteria: 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 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 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) Exclusion Criteria: 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.

Applicable Conditions:

  • Fatty Liver - NASH
  • Participation Institution:

  • No UF Health MRN
  • UF Gainesville
  • UF Jacksonville
  • More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03900429