StudyFinder
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
Recruiting
18 years and over
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.
Drug: MGL-3196, Drug: Placebo
NASH - Nonalcoholic Steatohepatitis
Kimberly Dorney, RN, MSN - info@madrigalpharma.com
Sanyal, Arun, J
Phase 3
HM20016537
NCT03900429
See this study on ClinicalTrials.gov