Studieninformationen
Kurztitel:
MGL-3196-11
Beschreibung:
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
Studiendesign:
Phase III, , Monozentrisch, National
Therapielinien:
Alter:
>= 18 Jahre
Erkrankungen:
Ein-/Ausschlusskriterien:
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.
NCT-Nummer:
Eudract-Nummer:
Studienaktive Standorte
Universitätsklinikum Würzburg
97080 Würzburg
Medizinische Klinik II, Schwerpunkt Hepatologie
Rekrutierung läuft
Herr Prof. Dr. Andreas Geier
Geier_A2@ukw.de
Herr PD Dr. Oliver Götze
Goetze_O@ukw.de