| Outcome Measures: |
Primary: Histological resolution of NASH without worsening of fibrosis, NAFLD status will be assessed by histologic evaluation of liver biopsy samples based on NAFLD activity score. NASH resolution is defined by disappearance of ballooning (score 0), together with either disappearance of lobular inflammation or the persistence of mild lobular inflammation only (score 0 or 1) and resulting in an overall pathologic diagnosis of either steatosis alone or steatosis with mild inflammation; with no worsening of fibrosis. Worsening of fibrosis is defined by an increase of at least one stage of the Kleiner fibrosis classification., from baseline to 48 weeks | Secondary: Overall NAFLD activity score (NAS), Sum of a) steatosis (0-3 points), b) lobular inflammation (scored 0-3 points), c) hepatocellular ballooning (scored 0-2 points) assessed by liver histology, from baseline to 48 weeks|Stage of fibrosis according to the Kleiner Fibrosis Classification, Assessed by liver histology according to the Kleiner Fibrosis Classification (stages 0-4), from baseline to 48 weeks|Activity component of NASH according to the steatosis-activity-fibrosis (SAF) score, Sum of lobular inflammation (scored 0-3 points)and hepatocellular ballooning (scored 0-2 points) assessed by liver histology, from baseline to 48 weeks|Hepatic steatosis grade, steatosis grade (0-3) assessed by liver histology, from baseline to 48 weeks
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| Locations: |
Medizinische Universität Graz, Graz, 8010, Austria|Medizinische Universität Innsbruck, Innsbruck, Austria|Wiener Gesundheitsverbund, Klinik Landstraße, Wien, 1030, Austria|Medizinische Universität Wien, Wien, Austria|Wiener Gesundheitsverbund, Klinik Hietzing, Wien, Austria|German Diabetes Center, Duesseldorf, Nordrhein-Westfalen, 40225, Germany|Herz- und Diabeteszentrum NRW, Bad Oeynhausen, 32545, Germany|Franziskus-Krankenhaus Berlin, Berlin, 10787, Germany|Leber- und Studienzentrum Checkpoint, Berlin, 10961, Germany|University Clinics Berlin Charité, Berlin, 12200, Germany|University Clinics Berlin Charité, Berlin, 13353, Germany|University Clinics Bochum, Bochum, 44892, Germany|Städtisches Klinikum Brandenburg GmbH, Brandenburg, 14770, Germany|Städtisches Klinikum Braunschweig gGmbH, Braunschweig, 38126, Germany|University Clinics Carl Gustav Carus Dresden, Dresden, 01307, Germany|Universitätsklinikum Düsseldorf, Düsseldorf, 40225, Germany|University Clinics Essen, Essen, 45147, Germany|University Clinics Frankfurt, Frankfurt, 60590, Germany|University Clinics Freiburg, Freiburg, 79106, Germany|University Clinics Heidelberg, Heidelberg, 69120, Germany|Eugastro GmbH, Leipzig, 04103, Germany|University Clinics Johannes-Gutenberg Mainz, Mainz, 55131, Germany|TUM, München, 81675, Germany|University Clinics Tübingen, Tübingen, 72076, Germany|Universitätsklinikum Ulm, Ulm, 89081, Germany|University Clinics Würzburg, Würzburg, 97080, Germany
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