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7BR",{"type":49,"coordinates":2892},[2893,2894],-3.78019,51.59241,{"lat":2894,"lon":2893},[2897],{"name":42,"role":37,"phone":11,"phoneExt":11,"email":11},{"facility":42,"status":43,"city":2899,"state":11,"zip":2900,"country":2810,"cosmosGeoPoint":2901,"geoPoint":2905,"contacts":2906},"Portsmouth","P06 3LY",{"type":49,"coordinates":2902},[2903,2904],-1.09125,50.79899,{"lat":2904,"lon":2903},[2907],{"name":42,"role":37,"phone":11,"phoneExt":11,"email":11},{"facility":42,"status":43,"city":2909,"state":11,"zip":2910,"country":2810,"cosmosGeoPoint":2911,"geoPoint":2915,"contacts":2916},"Southampton","SO16 6YD",{"type":49,"coordinates":2912},[2913,2914],-1.40428,50.90395,{"lat":2914,"lon":2913},[2917],{"name":42,"role":37,"phone":11,"phoneExt":11,"email":11},{"type":2919,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100548313",false,"NCT06419374","A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).\n* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.\n* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.\n* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \\\u003C50.0 kilograms (kg)\u002Fmeters squared (m\\^2).\n\nKey Exclusion Criteria:\n\n* Liver disorder other than MASH.\n* History or evidence of hepatic decompensation.\n* History or evidence of hepatocellular carcinoma.\n* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.\n* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL).\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) must be on stable dose for at least 6 months prior to screening.\n\nOther protocol-defined inclusion and exclusion criteria may apply.","ALL","18 Years","75 Years",{"count":2930,"type":2931},762,"ESTIMATED","INTERVENTIONAL",[2934],"PHASE3","The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \\[previously known as nonalcoholic steatohepatitis, NASH\\]).",[2937],"Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis",[2939,2940,2941,2942,2943,2944,2945,2946,2947,2948,2949,2950,2951,2952],"Liver disease","Fatty Liver","Digestive System Diseases","Metabolic diseases","Metabolic Dysfunction-Associated Steatohepatitis","MASH","Nonalcoholic steatohepatitis","NASH","Metabolic dysfunction-associated steatotic liver disease","MASLD","Nonalcoholic fatty liver disease","NAFLD","Fibrosis","Cirrhosis","2026-06-02",{"date":2955,"type":2956},"2026-06-04","ACTUAL",{"date":2958,"type":2956},"2024-05-24",{"date":2960,"type":2931},"2031-08",{"name":5,"class":6},303]