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
Phase III, , Monozentrisch, National
>= 18 Jahre
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.
Studienaktive Standorte
Universitätsklinikum Würzburg
97080 Würzburg
Medizinische Klinik II, Schwerpunkt Hepatologie
Rekrutierung läuft
Herr Prof. Dr. Andreas Geier
Herr PD Dr. Oliver Götze