[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05718570":3,"trial-entities:NCT05718570":475,"trial-summary:NCT05718570":479},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":43,"sex":102,"minimum_age":103,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":104,"std_ages":108,"locations":111,"central_contacts":468,"overall_officials":469,"references":473,"see_also_links":474},"NCT05718570","NN8640-4515","A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information","A Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical Practice","ENROLLING_BY_INVITATION","2032-12-15","2026-06","2026-06-12","2023-02-03","Novo Nordisk A\u002FS","INDUSTRY",false,"In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.",null,[19],"Adult Growth Hormone Deficiency",[],"OBSERVATIONAL",[],{"count":24,"type":25},400,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DRUG","Somapacitan","Sogroya therapy in participants with AGHD.",[32],"Participants with Adult Growth Hormone Deficiency (AGHD)",[34,38,41],{"measure":35,"description":36,"timeFrame":37},"Number of Adverse drug reaction (ADRs)","Measured as count of events.","From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)",{"measure":39,"description":40,"timeFrame":37},"Incident Neoplasm","Measured as number of participants (yes\u002Fno).",{"measure":42,"description":40,"timeFrame":37},"Incident Diabetes Mellitus type 2",[44,46,48,51,54,57,60,63,66,69,72,75,78,81,84,86,88,91,94,97,100],{"measure":45,"description":36,"timeFrame":37},"Number of Adverse Events (AEs)",{"measure":47,"description":36,"timeFrame":37},"Number of Serious Adverse Events (SAEs)",{"measure":49,"description":50,"timeFrame":37},"Number of Medication Errors (incorrect dose administration rate)","Measured as count of errors.",{"measure":52,"description":53,"timeFrame":37},"Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)","Measured as score ranging from -10 to +10.",{"measure":55,"description":40,"timeFrame":56},"Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2)","Approximately (closest routine clinical) 12 months after enrolment in study",{"measure":58,"description":59,"timeFrame":37},"Change in Weight","Measured as kilogram (kg).",{"measure":61,"description":62,"timeFrame":37},"Change in Body Mass Index (BMI)","Measured as kilogram per square meter (kg\\^m2).",{"measure":64,"description":65,"timeFrame":37},"Change in waist circumference","Measured as centimeter (cm).",{"measure":67,"description":68,"timeFrame":37},"Change in waist-hip ratio","Measured as ratio.",{"measure":70,"description":71,"timeFrame":37},"Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides)","Measured as milligrams per deciliter (mg\u002FdL).",{"measure":73,"description":74,"timeFrame":37},"Change in glycated hemoglobin (HbA1C)","Measured as percentage (%).",{"measure":76,"description":77,"timeFrame":37},"Change in bone density","Measured as grams per square centimeter (g\u002Fcm\\^2).",{"measure":79,"description":80,"timeFrame":37},"Change in bone mineral content","Measured as grams (g).",{"measure":82,"description":83,"timeFrame":37},"Change in total body fat-mass","Measured as kg.",{"measure":85,"description":83,"timeFrame":37},"Change in truncal fat-mass",{"measure":87,"description":83,"timeFrame":37},"Change in lean body mass",{"measure":89,"description":90,"timeFrame":37},"Change in body fat percentage","Measured as %.",{"measure":92,"description":93,"timeFrame":37},"Change in visceral adipose tissue (VAT)","Measured as cm\\^2.",{"measure":95,"description":96,"timeFrame":37},"Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin)","Measured as Units per liter (U\u002FL).",{"measure":98,"description":99,"timeFrame":37},"Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)","Measured as score ranging from -100 to +100. Lower score indicates a better health state.",{"measure":101,"description":40,"timeFrame":56},"Patient reaching satisfactory clinical response","ALL","18 Years",{"inclusion":105,"exclusion":106,"raw_text":107},[],[],"Inclusion Criteria:\n\n1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n2. The decision to initiate treatment with commercially available Sogroya (somapacitan) has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.\n3. Male or female, age above or equal to 18 years assigned to Sogroya (somapacitan) treatment at the time of signing informed consent.\n4. Diagnosis of adult growth hormone deficiency (AGHD) as per local practice.\n\nExclusion Criteria:\n\n1. Previous participation in this study. Participation is defined as signed informed consent.\n2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.\n3. Participant with hypersensitivity to the active substance or to any of the excipients.\n4. Participant with active malignancy or in treatment for active pre-existing malignancy.\n5. Participant with acute critical illness, suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions per investigator judgement.",[109,110],"ADULT","OLDER_ADULT",[112,121,129,133,140,147,155,163,171,179,187,195,199,203,211,219,227,234,241,245,253,260,268,276,284,288,295,302,310,314,322,329,336,343,350,358,365,372,379,386,390,393,400,403,410,415,419,426,430,434,438,446,449,456,460],{"facility":113,"city":114,"state":115,"zip":116,"country":117,"geoPoint":118},"Barrow Neurological Institute","Phoenix","Arizona","85013","United States",{"lat":119,"lon":120},33.44838,-112.07404,{"facility":122,"city":123,"state":124,"zip":125,"country":117,"geoPoint":126},"Keck Medical Center of USC - Outpatient Clinic","Los Angeles","California","90033",{"lat":127,"lon":128},34.05223,-118.24368,{"facility":130,"city":123,"state":124,"zip":131,"country":117,"geoPoint":132},"UCLA Health","90095",{"lat":127,"lon":128},{"facility":134,"city":135,"state":124,"zip":136,"country":117,"geoPoint":137},"Stanford Univ School of Med","Palo Alto","94304",{"lat":138,"lon":139},37.44188,-122.14302,{"facility":141,"city":142,"state":124,"zip":143,"country":117,"geoPoint":144},"Advanced Rx Clinical Research","Westminster","92683",{"lat":145,"lon":146},33.75918,-118.00673,{"facility":148,"city":149,"state":150,"zip":151,"country":117,"geoPoint":152},"Anschutz Outpatient Pavilion","Aurora","Colorado","80045",{"lat":153,"lon":154},39.72943,-104.83192,{"facility":156,"city":157,"state":158,"zip":159,"country":117,"geoPoint":160},"Metabolic Research Institute Inc","West Palm Beach","Florida","33401",{"lat":161,"lon":162},26.71534,-80.05337,{"facility":164,"city":165,"state":166,"zip":167,"country":117,"geoPoint":168},"Atlanta Diabetes Associates","Atlanta","Georgia","30318",{"lat":169,"lon":170},33.749,-84.38798,{"facility":172,"city":173,"state":174,"zip":175,"country":117,"geoPoint":176},"Northwestern Medical Group","Chicago","Illinois","60642",{"lat":177,"lon":178},41.85003,-87.65005,{"facility":180,"city":181,"state":182,"zip":183,"country":117,"geoPoint":184},"Johns Hopkins University","Baltimore","Maryland","21287",{"lat":185,"lon":186},39.29038,-76.61219,{"facility":188,"city":189,"state":190,"zip":191,"country":117,"geoPoint":192},"Tufts Medical Center","Boston","Massachusetts","02111",{"lat":193,"lon":194},42.35843,-71.05977,{"facility":196,"city":189,"state":190,"zip":197,"country":117,"geoPoint":198},"Massachusetts General Hospital","02114",{"lat":193,"lon":194},{"facility":200,"city":189,"state":190,"zip":201,"country":117,"geoPoint":202},"Brigham & Women's Hospital","02115",{"lat":193,"lon":194},{"facility":204,"city":205,"state":206,"zip":207,"country":117,"geoPoint":208},"Washington University","St Louis","Missouri","63110",{"lat":209,"lon":210},38.62727,-90.19789,{"facility":212,"city":213,"state":214,"zip":215,"country":117,"geoPoint":216},"UNMC","Omaha","Nebraska","68198",{"lat":217,"lon":218},41.25626,-95.94043,{"facility":220,"city":221,"state":222,"zip":223,"country":117,"geoPoint":224},"Palm Research Center Inc-Vegas","Las Vegas","Nevada","89148",{"lat":225,"lon":226},36.17497,-115.13722,{"facility":228,"city":229,"state":222,"zip":230,"country":117,"geoPoint":231},"Northern Nevada Endocrinology","Reno","89511",{"lat":232,"lon":233},39.52963,-119.8138,{"facility":235,"city":236,"state":236,"zip":237,"country":117,"geoPoint":238},"NYU Langone Orthopedic Center","New York","10017",{"lat":239,"lon":240},40.71427,-74.00597,{"facility":242,"city":236,"state":236,"zip":243,"country":117,"geoPoint":244},"Cornell University","10021",{"lat":239,"lon":240},{"facility":246,"city":247,"state":248,"zip":249,"country":117,"geoPoint":250},"University of North Carolina","Chapel Hill","North Carolina","27514",{"lat":251,"lon":252},35.9132,-79.05584,{"facility":254,"city":255,"state":248,"zip":256,"country":117,"geoPoint":257},"Physicians East Endocrinology","Greenville","27834",{"lat":258,"lon":259},35.61266,-77.36635,{"facility":261,"city":262,"state":263,"zip":264,"country":117,"geoPoint":265},"Oregon Health & Science University","Portland","Oregon","97239",{"lat":266,"lon":267},45.52345,-122.67621,{"facility":269,"city":270,"state":271,"zip":272,"country":117,"geoPoint":273},"St Lukes Physician Group","Center Valley","Pennsylvania","18034",{"lat":274,"lon":275},40.52927,-75.39324,{"facility":277,"city":278,"state":279,"zip":280,"country":117,"geoPoint":281},"Revival Research Institute, LLC","Dallas","Texas","75231",{"lat":282,"lon":283},32.78306,-96.80667,{"facility":285,"city":278,"state":279,"zip":286,"country":117,"geoPoint":287},"UT Southwestern Medical Center-CRU","75390",{"lat":282,"lon":283},{"facility":289,"city":290,"state":279,"zip":291,"country":117,"geoPoint":292},"EP Premier Medical Group PA","El Paso","79935",{"lat":293,"lon":294},31.75872,-106.48693,{"facility":296,"city":297,"state":279,"zip":298,"country":117,"geoPoint":299},"Consano Clinical Research, LLC","Shavano Park","78231",{"lat":300,"lon":301},29.58495,-98.55252,{"facility":303,"city":304,"state":305,"zip":306,"country":117,"geoPoint":307},"Puget Sound VA, University of Washington","Seattle","Washington","98108-1597",{"lat":308,"lon":309},47.60621,-122.33207,{"facility":311,"city":304,"state":305,"zip":312,"country":117,"geoPoint":313},"University Of Washington_Seattle","98195-6165",{"lat":308,"lon":309},{"facility":315,"city":316,"zip":317,"country":318,"geoPoint":319},"HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie","Bron","69500","France",{"lat":320,"lon":321},45.73865,4.91303,{"facility":323,"city":324,"zip":325,"country":318,"geoPoint":326},"CHU LILLE - HOPITAL CLAUDE HURIEZ - Service d'endocrinologie et diabétologie","Lille","59000",{"lat":327,"lon":328},50.63391,3.05512,{"facility":330,"city":331,"zip":332,"country":318,"geoPoint":333},"APHM - HOPITAL DE LA CONCEPTION - Service d'endocrinologie, nutrition, diabète et obésité","Marseille","13005",{"lat":334,"lon":335},43.29695,5.38107,{"facility":337,"city":338,"zip":339,"country":318,"geoPoint":340},"APHP - LA PITIE SALPETRIERE_Service endrocrinologie et medecine de la reproduction","Paris","75013",{"lat":341,"lon":342},48.85341,2.3488,{"facility":344,"city":345,"zip":346,"country":318,"geoPoint":347},"CHU REIMS - HOPITAL ROBERT DEBRE - Service Endocrinologie-Diabète-Nutrition","Reims","51100",{"lat":348,"lon":349},49.26526,4.02853,{"facility":351,"city":352,"zip":353,"country":354,"geoPoint":355},"Uniklinik Aachen - Endokrinologie und Diabetologie","Aachen","52074","Germany",{"lat":356,"lon":357},50.77664,6.08342,{"facility":359,"city":360,"zip":361,"country":354,"geoPoint":362},"Endokrinologikum Frankfurt","Frankfurt am Main","60596",{"lat":363,"lon":364},50.11552,8.68417,{"facility":366,"city":367,"zip":368,"country":354,"geoPoint":369},"Universitätsklinikum Halle - Innere Medizin III","Halle","06120",{"lat":370,"lon":371},51.48158,11.97947,{"facility":373,"city":374,"zip":375,"country":354,"geoPoint":376},"Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen","Mainz","55131",{"lat":377,"lon":378},49.98185,8.28008,{"facility":380,"city":381,"zip":382,"country":354,"geoPoint":383},"LMU Klinikum Großhadern München - Med. Klinik","München","80336",{"lat":384,"lon":385},51.60698,13.31243,{"facility":387,"city":381,"zip":388,"country":354,"geoPoint":389},"Medicover Neuroendokrinologie MVZ München","81667",{"lat":384,"lon":385},{"facility":391,"city":381,"zip":388,"country":354,"geoPoint":392},"Medicover Neuroendokrinologie MVZ",{"lat":384,"lon":385},{"facility":394,"city":395,"zip":396,"country":354,"geoPoint":397},"Medicover MVZ Oldenburg","Oldenburg","26122",{"lat":398,"lon":399},53.14039,8.21479,{"facility":401,"city":395,"zip":396,"country":354,"geoPoint":402},"Medicover Oldenburg MVZ",{"lat":398,"lon":399},{"facility":404,"city":405,"zip":406,"country":354,"geoPoint":407},"Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)","Würzburg","97080",{"lat":408,"lon":409},49.79391,9.95121,{"facility":411,"city":412,"zip":413,"country":414},"Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus","Chikushino-shi, Fukuoka","818-8502","Japan",{"facility":416,"city":417,"zip":418,"country":414},"Kagoshima University Hospital_Neurosurgery","Kagoshima-shi, Kagoshima","890-8520",{"facility":420,"city":421,"zip":422,"country":414,"geoPoint":423},"Nippon Medical School Musashikosugi Hospital_Neurological Surgery","Kawasaki-shi, Kanagawa","211-8533",{"lat":424,"lon":425},37.58333,139.91667,{"facility":427,"city":428,"zip":429,"country":414},"Kobe University Hospital_Diabetes and Endocrinology","Kobe-shi, Hyogo","650-0017",{"facility":431,"city":432,"zip":433,"country":414},"Okayama University Hospital_General Medicine","Okayama-shi, Okayama","700-8558",{"facility":435,"city":436,"zip":437,"country":414},"Osaka City General Hospital_Endocrinology and Diabetes Mellitus","Osaka-shi, Osaka","534-0021",{"facility":439,"city":440,"zip":441,"country":442,"geoPoint":443},"Dr Soliman Fakeeh Hospital","Jeddah","23323","Saudi Arabia",{"lat":444,"lon":445},21.49012,39.18624,{"facility":447,"city":440,"country":442,"geoPoint":448},"My clinic",{"lat":444,"lon":445},{"facility":450,"city":451,"zip":452,"country":442,"geoPoint":453},"Dr. Sulaiman Al Habib Medical Group- Olaya","Riyadh","11643",{"lat":454,"lon":455},24.68773,46.72185,{"facility":457,"city":451,"zip":458,"country":442,"geoPoint":459},"King Fahad Medical City","59046",{"lat":454,"lon":455},{"facility":461,"city":462,"zip":463,"country":464,"geoPoint":465},"UKC Ljubljana, Endocrinology and Diabetes","Ljubljana","1000","Slovenia",{"lat":466,"lon":467},46.05108,14.50513,[],[470],{"name":471,"affiliation":13,"role":472},"Clinical Transparency (dept. 2834)","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":476,"biomarkers":478},[477],"Adult growth hormone deficiency",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]