[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585948":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":66,"collaborators":68,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":41,"enrollmentInfo":87,"targetDuration":41,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":103,"overallStatus":113,"whyStopped":41,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Nordsjaellands Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide","ACTIVE_COMPARATOR","Subcutaneous injection through injector pen with the active comparator Semaglutide once a week in monthly increasing doses as given: 0.25mg - 0.5mg - 1.0mg - 1.7mg - 2.4mg",[13],"Drug: Semaglutide 2.4mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Semaglutide placebo","PLACEBO_COMPARATOR","Visually identical injector pen without the active comparator.",[19],"Drug: Semaglutide placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Semaglutide 2.4mg","The active comparator of the intervention is s.c. Semaglutide injection once a week in increasing doses every month from 0.25 mg to 0.5 mg to 1.0 mg to 1.7 mg to 2.4 mg and the placebo comparator is s.c. injection with a visually identical and same label pen as described for the active comparator",[9],[27],"Active semaglutide",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Visually identical and same label as the active comparator intervention",[15],[32],"Placebo semaglutide",[34],{"name":35,"affiliation":5,"role":36},"Thomas F Dejgaard, MD, ph.d., endocrinologist","STUDY_CHAIR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","0045 26 79 61 03",null,"Thomas.fremming.dejgaard@regionh.dk",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Hasan I Mirza, MD, ph.d.-student","0045 42 37 58 40","hasan.imran.mirza@regionh.dk",[48],{"facility":5,"status":41,"city":49,"state":50,"zip":51,"country":50,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hillerød","Denmark","3400","DK",{"type":54,"coordinates":55},"Point",[56,57],12.30081,55.92791,{"lat":57,"lon":56},[60,61,62,64],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},{"name":35,"role":63,"phone":41,"phoneExt":41,"email":41},"PRINCIPAL_INVESTIGATOR",{"name":44,"role":65,"phone":41,"phoneExt":41,"email":41},"SUB_INVESTIGATOR",{"type":67,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[69,71,73,75],{"name":70,"class":6},"Steno Diabetes Center Copenhagen",{"name":72,"class":6},"Steno Diabetes Center Odense",{"name":74,"class":6},"Zealand University Hospital",{"name":76,"class":6},"Aarhus University Hospital","100585948","phase-3-semaglutide-treatment-in-type-1-diabetes-100585948",false,"NCT06909006","Semaglutide Treatment in Type 1 Diabetes","Obesity and Semaglutide in Type 1 Diabetes Therapy: A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial","OBES1TY","Inclusion Criteria:\n\n* Type 1 Diabetes for more than 3 years\n* BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis\n\nExclusion Criteria:\n\n* Treated with GLP1-RAs within last 6 months\n* Known intolerance for semaglutide\n* Other forms of diabetes\n* Pregnant or nursing women\n* Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives\n* Liver disease with elevated plasma alanine aminotransferase (ALT) \\> five times and plasma aspartate aminotransferase (AST) \\> five times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)\n* Acute or chronic pancreatitis\n* Cancer, unless in complete remission for \\> 5 years or unless basocellular carcinomas\n* History of thyroid adenoma or carcinoma\n* Alcohol\u002Fdrug abuse\n* Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation\n* Receipt of an investigational drug within 30 days prior to visit 0 \u002F Simultaneous participation in any other clinical intervention trial","ALL","18 Years",{"count":88,"type":89},122,"ESTIMATED","INTERVENTIONAL",[92],"PHASE3","The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.",[95,96,97,98,9,99,100,101,102],"Obesity in Diabetes","Obesity\u002FTherapy","Type 1 Diabetes Mellitus (T1DM)","Insulin Sensitivity\u002FResistance","Lipidomics","Metabolomics","Weight Loss","Glycemic Control for Diabetes Mellitus",[9,104,105,106,107,108,109,110,111,112],"Obesity","Type 1 Diabetes","Obese Type 1 Diabetics","Insulin sensitivity","Insulin resistance","Weight loss","GLP1-RA","GLP1","Wegovy","NOT_YET_RECRUITING","2025-08-04",{"date":116,"type":117},"2025-08-08","ACTUAL",{"date":119,"type":89},"2025-10",{"date":121,"type":89},"2028-06",{"name":5,"class":6},1]