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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1264-8642 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Adult Growth Hormone Deficiency (AGHD) | Participants will be treated with commercially available Sogroya according to routine clinical practice at the discretion of the treating physician. The decision to treat a participant with Sogroya has been made prior to and independently from the decision to include the participant in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somapacitan | Drug | Sogroya therapy in participants with AGHD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Incident Neoplasm | Measured as number of participants (yes/no). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Incident Diabetes Mellitus type 2 | Measured as number of participants (yes/no). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Measured as count of events. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Number of Serious Adverse Events (SAEs) | Measured as count of events. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Adult Growth Hormone Deficiency
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Keck Medical Center of USC - Outpatient Clinic |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Number of Medication Errors (incorrect dose administration rate) | Measured as count of errors. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS) | Measured as score ranging from -10 to +10. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2) | Measured as number of participants (yes/no). | Approximately (closest routine clinical) 12 months after enrolment in study |
| Change in Weight | Measured as kilogram (kg). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in Body Mass Index (BMI) | Measured as kilogram per square meter (kg^m2). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in waist circumference | Measured as centimeter (cm). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in waist-hip ratio | Measured as ratio. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides) | Measured as milligrams per deciliter (mg/dL). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in glycated hemoglobin (HbA1C) | Measured as percentage (%). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in bone density | Measured as grams per square centimeter (g/cm^2). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in bone mineral content | Measured as grams (g). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in total body fat-mass | Measured as kg. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in truncal fat-mass | Measured as kg. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in lean body mass | Measured as kg. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in body fat percentage | Measured as %. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in visceral adipose tissue (VAT) | Measured as cm^2. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin) | Measured as Units per liter (U/L). | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| 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. | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) |
| Patient reaching satisfactory clinical response | Measured as number of participants (yes/no). | Approximately (closest routine clinical) 12 months after enrolment in study |
| Los Angeles |
| California |
| 90033 |
| United States |
| UCLA Health | Los Angeles | California | 90095 | United States |
| Stanford Univ School of Med | Palo Alto | California | 94304 | United States |
| Advanced Rx Clinical Research | Westminster | California | 92683 | United States |
| Anschutz Outpatient Pavilion | Aurora | Colorado | 80045 | United States |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Northwestern Medical Group | Chicago | Illinois | 60642 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| UNMC | Omaha | Nebraska | 68198 | United States |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89148 | United States |
| Northern Nevada Endocrinology | Reno | Nevada | 89511 | United States |
| NYU Langone Orthopedic Center | New York | New York | 10017 | United States |
| Cornell University | New York | New York | 10021 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Physicians East Endocrinology | Greenville | North Carolina | 27834 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| St Lukes Physician Group | Center Valley | Pennsylvania | 18034 | United States |
| Revival Research Institute, LLC | Dallas | Texas | 75231 | United States |
| UT Southwestern Medical Center-CRU | Dallas | Texas | 75390 | United States |
| EP Premier Medical Group PA | El Paso | Texas | 79935 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Puget Sound VA, University of Washington | Seattle | Washington | 98108-1597 | United States |
| University Of Washington_Seattle | Seattle | Washington | 98195-6165 | United States |
| HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie | Bron | 69500 | France |
| CHU LILLE - HOPITAL CLAUDE HURIEZ - Service d'endocrinologie et diabétologie | Lille | 59000 | France |
| APHM - HOPITAL DE LA CONCEPTION - Service d'endocrinologie, nutrition, diabète et obésité | Marseille | 13005 | France |
| APHP - LA PITIE SALPETRIERE_Service endrocrinologie et medecine de la reproduction | Paris | 75013 | France |
| CHU REIMS - HOPITAL ROBERT DEBRE - Service Endocrinologie-Diabète-Nutrition | Reims | 51100 | France |
| Uniklinik Aachen - Endokrinologie und Diabetologie | Aachen | 52074 | Germany |
| Endokrinologikum Frankfurt | Frankfurt am Main | 60596 | Germany |
| Universitätsklinikum Halle - Innere Medizin III | Halle | 06120 | Germany |
| Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen | Mainz | 55131 | Germany |
| LMU Klinikum Großhadern München - Med. Klinik | München | 80336 | Germany |
| Medicover Neuroendokrinologie MVZ München | München | 81667 | Germany |
| Medicover Neuroendokrinologie MVZ | München | 81667 | Germany |
| Medicover MVZ Oldenburg | Oldenburg | 26122 | Germany |
| Medicover Oldenburg MVZ | Oldenburg | 26122 | Germany |
| Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM) | Würzburg | 97080 | Germany |
| Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus | Chikushino-shi, Fukuoka | 818-8502 | Japan |
| Kagoshima University Hospital_Neurosurgery | Kagoshima-shi, Kagoshima | 890-8520 | Japan |
| Nippon Medical School Musashikosugi Hospital_Neurological Surgery | Kawasaki-shi, Kanagawa | 211-8533 | Japan |
| Kobe University Hospital_Diabetes and Endocrinology | Kobe-shi, Hyogo | 650-0017 | Japan |
| Okayama University Hospital_General Medicine | Okayama-shi, Okayama | 700-8558 | Japan |
| Osaka City General Hospital_Endocrinology and Diabetes Mellitus | Osaka-shi, Osaka | 534-0021 | Japan |
| Dr Soliman Fakeeh Hospital | Jeddah | 23323 | Saudi Arabia |
| My clinic | Jeddah | Saudi Arabia |
| Dr. Sulaiman Al Habib Medical Group- Olaya | Riyadh | 11643 | Saudi Arabia |
| King Fahad Medical City | Riyadh | 59046 | Saudi Arabia |
| UKC Ljubljana, Endocrinology and Diabetes | Ljubljana | 1000 | Slovenia |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000718308 | somapacitan |
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