[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488792":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":38,"responsibleParty":55,"collaborators":20,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":20,"overallStatus":41,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Getz Pharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ertugliflozin","EXPERIMENTAL","Ertugliflozin 5\u002F15mg once daily with standard of care",[13],"Drug: Ertugliflozin 5 mg, 15mg",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ertugliflozin 5 mg, 15mg","Ertugliflozin 5\u002F15mg once daily in addition to standard of care",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Umar Raja, MBBS","Shifa International Hospital","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Muhammad Nabeed Tahir, MBBS","CONTACT","+923015376299","2907","nabeedtahir@getzpharma.com",{"name":34,"role":29,"phone":35,"phoneExt":36,"email":37},"Jahanzeb Kamal Khan, MBBS","+923201212945","8386","jahanzeb.kamal@getzpharma.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":20,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"North west general hospital","RECRUITING","Peshawar","KPK","Pakistan","PK",{"type":47,"coordinates":48},"Point",[49,50],71.57849,34.008,{"lat":50,"lon":49},[53],{"name":54,"role":29,"phone":20,"phoneExt":20,"email":20},"Arshad Hussain, M.B.B.S",{"type":56,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100488792","phase-4-effect-of-erugliflozin-on-liver-fat-liver-fibrosis-and-glycemic-control-in-type-ii-dm-patients-with-nashnafld-100488792",false,"NCT05644717","Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH\u002FNAFLD","Effects of Ertugliflozin on Liver Fat, Liver Fibrosis & Glycemic Control in Subjects With Type 2 Diabetes Mellitus (T2DM) & Non-Alcoholic Fatty Liver Disease \u002FNon-Alcoholic Steatohepatitis","Ertu-NASH","Inclusion Criteria:\n\n* Patient able to provide written informed consent\n* Adult males \\& females between 18 to 65 years\n* SGLT2i and insulin naïve patients\n* BMI \\>23 Kg\u002Fm2\n* HbA1C % ≥ 6.5 to 10\n* Documented hepatic steatosis or fatty liver disease on Ultrasound\n* Patient with Type II Diabetes Mellitus\n\nExclusion Criteria:\n\n* History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study.\n* Pioglitazone use in the past 6 months\n* History of vitamin E use (400mg twice daily) 3 months prior to enrollment in the study.\n* History of anti-obesity medication or weight loss procedure (bariatric surgery) use within 3 months prior to enrollment in the study.\n* History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requires frequent dose adjustment, or Cushing's syndrome)\n* History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma and\u002For HIV\n* History of recurrent UTIs and mycotic infection.\n* Severely ill patients (who have high grade fever, sepsis or acute infection)\n* Pregnant woman, lactating woman or planning pregnancy during study duration\n* History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines).\n* History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and\u002For laboratory tests\n* Alcohol intake 10 - 30 g\u002Fday (three drinks per day) within the previous year\n* Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines.\n* Severe hepatic impairment ( AST \\& ALT levels \\> 3 times upper limit normal","ALL","18 Years","65 Years",{"count":69,"type":70},164,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \\& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)\u002FNon-Alcoholic Steatohepatitis (NASH)",[76,77,78,79,80,81],"Liver Fat","Liver Fibrosis","Glycemic Control","Body Weight Changes","Waist Circumference","Tolerance","2025-03-19",{"date":84,"type":85},"2025-03-21","ACTUAL",{"date":87,"type":85},"2023-03-01",{"date":89,"type":70},"2025-12-01",{"name":5,"class":6},1]