[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606837":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":54,"centralContacts":59,"locations":69,"responsibleParty":85,"collaborators":38,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":38,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":38,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":112,"whyStopped":38,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Badr University","OTHER",[8,14,19,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Pioglitazone","ACTIVE_COMPARATOR","30 mg once daily orally for 3 months",[13],"Drug: Pioglitazone (PIO)",{"label":15,"type":10,"description":16,"interventionNames":17},"Empagliflozin","10 mg once daily orally for 3 months",[18],"Drug: Empagliflozin",{"label":20,"type":10,"description":21,"interventionNames":22},"Statins","Once daily orally for 3 months",[23],"Drug: Statin (Atorvastatin)",{"label":25,"type":10,"description":21,"interventionNames":26},"Empagliflozin plus statins",[27],"Drug: Empagliflozin plus Statin (Atorvastatin)",{"label":29,"type":10,"description":21,"interventionNames":30},"Pioglitazone plus Statins",[31],"Drug: Pioglitazone plus Atorvastatin",[33,39,42,46,50],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Pioglitazone (PIO)","30 mg orally once daily",[9],null,{"type":34,"name":15,"description":40,"armGroupLabels":41,"otherNames":38},"10 mg orally once daily",[15],{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":38},"Statin (Atorvastatin)","20 mg orally once daily",[20],{"type":34,"name":47,"description":48,"armGroupLabels":49,"otherNames":38},"Empagliflozin plus Statin (Atorvastatin)","Orally once daily of each (10 mg, 20 mg respectively)",[25],{"type":34,"name":51,"description":52,"armGroupLabels":53,"otherNames":38},"Pioglitazone plus Atorvastatin","Orally once daily of each (30mg and 20mg respectively)",[29],[55],{"name":56,"affiliation":57,"role":58},"Eman Swan","Badr University in Cairo, Faculty of Pharmacy","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":38,"email":64},"Eman Swan, PHD","CONTACT","+201090111013","eman.said@buc.edu.eg",{"name":66,"role":62,"phone":67,"phoneExt":38,"email":68},"Raghda Hussien, PHD","+201010647666","Raghda.hussien@pharm.bsu.edu.eg",[70],{"facility":71,"status":38,"city":72,"state":38,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Teaching hospital of Beni Suef University","Banī Suwayf","62727","Egypt","EG",{"type":77,"coordinates":78},"Point",[79,80],31.09785,29.07441,{"lat":80,"lon":79},[83,84],{"name":66,"role":62,"phone":67,"phoneExt":38,"email":68},{"name":66,"role":62,"phone":38,"phoneExt":38,"email":68},{"type":58,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Eman Said Sawan","Lecturer","100606837","phase-4-empagliflozin-versus-statins-in-non-alcoholic-fatty-liver-disease-100606837",false,"NCT07180745","Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease","Assessment of Efficacy of Empagliflozin Versus Statins in Treatment of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis","Inclusion Criteria:\n\n* Adult\n* Obese\n* Hyperlipidemic\n* Diabetic patients\n* Diagnosed with non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis\n\nExclusion Criteria:\n\n* Pregnant women\n* Breast feeding women\n* Diabetic patients with ketoacidosis\n* Hyperlipidemic patients with cardiovascular dysfunction\n* Patients with NAFLD or NASH induced hepatocellular carcinoma\n* Hyperlipidemic obese diabetic patients diagnosed with NAFLD or NASH who will refuse to sign the informed consent","ALL","18 Years","65 Years",{"count":99,"type":100},400,"ESTIMATED","INTERVENTIONAL",[103],"PHASE4","The goal of this clinical trial is to assess the efficacy of Empagliflozin versus Statins as monotherapy and polytherapy in non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis.\n\nDoes drug ABC Empagliflozin versus Statins as monotherapy and polytherapy improve the controlled attenuation parameter (CAP), the liver stiffness measurement (LSM), the proportion of patients with at least one point improvement or one-stage reduction in the histological scores with respect to hepatic steatosis, hepatocellular ballooning, lobular inflammation, and fibrosis after treatment?\n\nWhat medical problems do participants have when taking Empagliflozin versus Statins as monotherapy and polytherapy?\n\nParticipants will:\n\n* Take Empagliflozin alone or Empagliflozin plus statins or Pioglitazone plus Statins or Pioglitazone alone as standard therapy every day for 3 months\n* Be directed to complete history taking. FibroScan®, abdominal ultrasound and laboratory tests of ALT, AST, ALP, platelets count, Triglycerides, Cholesterol, LDL, HDL, serum insulin and insulin resistance will be conducted at baseline and after the drug administration for 3 months.\n* Keep a diary of recording any side effects they use a rescue inhaler",[106,107],"Non-alcoholic Fatty Liver Disease NAFLD","Non-alcoholic Steatohepatitis NASH",[15,109,9,110,111],"Statin","NAFLD","NASH","NOT_YET_RECRUITING","2025-09-16",{"date":115,"type":116},"2025-09-18","ACTUAL",{"date":118,"type":100},"2025-11-01",{"date":120,"type":100},"2026-03-01",{"name":5,"class":6},1]