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City","80756","Taiwan","TW",{"type":58,"coordinates":734},[735,736],120.31333,22.61626,{"lat":736,"lon":735},{"facility":313,"status":48,"city":739,"state":48,"zip":740,"country":731,"countryCode":732,"cosmosGeoPoint":741,"geoPoint":745,"contacts":48},"Tainan","70403",{"type":58,"coordinates":742},[743,744],120.21333,22.99083,{"lat":744,"lon":743},{"facility":313,"status":48,"city":747,"state":748,"zip":749,"country":750,"countryCode":48,"cosmosGeoPoint":751,"geoPoint":755,"contacts":48},"Istanbul","Topkapi","34010","Turkey (Türkiye)",{"type":58,"coordinates":752},[753,754],28.94966,41.01384,{"lat":754,"lon":753},{"facility":313,"status":48,"city":757,"state":758,"zip":759,"country":760,"countryCode":761,"cosmosGeoPoint":762,"geoPoint":766,"contacts":48},"Aberdeen","Grampian Region","AB25 2ZN","United Kingdom","UK",{"type":58,"coordinates":763},[764,765],-2.09814,57.14369,{"lat":765,"lon":764},{"facility":313,"status":48,"city":768,"state":48,"zip":769,"country":760,"countryCode":761,"cosmosGeoPoint":770,"geoPoint":774,"contacts":48},"London","SE5 9RS",{"type":58,"coordinates":771},[772,773],-0.12574,51.50853,{"lat":773,"lon":772},{"type":776,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100367557","phase-2-efficacy-safety-and-tolerability-of-the-combination-of-tropifexor--licogliflozin-and-each-monotherapy-compared-with-placebo-in-adult-patients-with-nash-and-liver-fibrosis-100367557",true,"NCT04065841","Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.","A Randomized, Double-blind, Parallel-group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Oral Tropifexor (LJN452) & Licogliflozin (LIK066) Combination Therapy and Each Monotherapy, Compared With Placebo for Treatment of Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis.(ELIVATE)","ELIVATE","Inclusion Criteria:\n\nPresence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following:\n\n1. NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation and ballooning and\n2. Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at screening\n* HbA1c \\\u003C 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas\n* Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:\n\n  * Platelet count \\\u003C LLN (see Central laboratory manual).\n  * Serum albumin \\\u003C LLN (see Central laboratory manual).\n  * International Normalized Ratio (INR) \\> ULN (see Central laboratory manual).\n  * ALT or AST \\> 5× ULN (confirmed by 2 values during screening).\n  * Total bilirubin \\> ULN (see Central laboratory manual) (confirmed by 2 values during screening), including Gilbert's syndrome.\n  * Alkaline phosphatase \\> 300 IU\u002FL (confirmed by 2 values during screening).\n  * History of esophageal varices, ascites or hepatic encephalopathy\n  * Splenomegaly\n  * MELD score \\>12",false,"ALL","18 Years",{"count":789,"type":790},234,"ACTUAL","INTERVENTIONAL",[793],"PHASE2","Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \\& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.",[796],"Non Alcoholic Steatohepatitis (NASH)",[798,799,32,36,38,42,45],"NASH","Non alcoholic steatohepatitis","TERMINATED","The sponsor made a business decision to stop development of the trial drugs. The decision to stop the trial early was not because of any safety concerns.","2025-01-06",{"date":804,"type":790},"2025-01-28",{"date":806,"type":790},"2019-12-30",{"date":808,"type":790},"2022-10-27",{"name":810,"class":6},"Novartis Pharmaceuticals",80]