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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1295-4799 | Other Identifier | World Health Organisation (WHO) | |
| 2023-508055-40 | Other Identifier | European Medical Agency (EMA) |
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The study is testing how well semaglutide can help adolescents with excess body weight to lose weight and to maintain weight loss. All participants in the study will receive semaglutide as a weekly injection. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. All participants will get semaglutide treatment for a minimum of 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | 2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Participants will receive semaglutide s.c(under the skin) once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Body Mass Index (BMI) below obesity threshold | Measures as count of participants | From 1.5 years to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of improved Body Mass Index (BMI) category | Measured as count of participants | From 1.5 years to 3 years and end of continued treatment phase (up to 6 years) |
| Tapering to zero dose |
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Inclusion criteria:
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study:
Age 12 to less than 15 years at the time of signing the informed consent
BMI greater than or equal to 95th percentile at screening
Body weight greater than 60 kg at screening
Exclusion criteria:
Prepubertal status (Tanner stage 1)
Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
Endocrine, hypothalamic, or syndromic obesity
History of type 1 or type 2 diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neighborhood Healthcare | Escondido | California | 92025 | United States | ||
| Clinical Neuroscience Solution |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Measured as count of participants
| From 1.5 years to 3 years |
| Time/dose steps before ending dose tapering | Measured in weeks, count of dose steps | From 1.5 years to 3 years |
| Achieving Body Mass Index (BMI) below obesity threshold | Measured as count of participants | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) |
| Achieving any improvement in Body Mass Index (BMI) category | Measured as count of participants | From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years) |
| Change in Body Mass Index (BMI) | Measured in percentage (%) | From baseline (day 0) to 1.5 and 3 years |
| Body Mass Index (BMI) percentage of the 95th percentile | Measured in percentage (%) | From baseline (day 0) to 1.5 and 3 years |
| Change in Body Mass Index Standard Deviation Score (BMI SDS) | Unitless | From baseline (day 0) to 1.5 and 3 years |
| Change in waist-to-height ratio (waist [cm]/ height [cm]) | Unitless | From baseline (day 0) to 1.5 and 3 years |
| Change in waist circumference | Measured in centimeters (cm) | From baseline (day 0) to 1.5 and 3 years |
| Change in HbA1c | Measured in percentage (%) points | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) |
| Change in fasting plasma glucose | Measured in millimol per liter (mmol/L), milligram per deciliter (mg/dL) | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) |
| Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Measured in percentage (%) | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) |
| Change in high sensitivity C-reactive protein (hsCRP) | Measured in percentage (%) | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) |
| Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides | Measured in percentage (%) | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) |
| Change in systolic and diastolic blood pressure | Measured in millimetres of mercury (mmHg) | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) |
| Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass | Measured in percentage (%) points | From baseline (day 0) to 1.5 and 3 years |
| Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass | Measured in percentage (%) points | From baseline (day 0) to 1.5 and 3 years |
| Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA) | Measured in percentage (%) | From baseline (day 0) to 1.5 and 3 years |
| Serious Adverse Event (SAE) | Count | From baseline (day 0) to 1.5 years, from 1.5 to 3 years, and from 3 years to end of continued treatment phase (up to 6 years) |
| Orlando |
| Florida |
| 32801 |
| United States |
| TMH Physician Partners Endo | Tallahassee | Florida | 32308 | United States |
| Children's Healthcare Atlanta | Atlanta | Georgia | 30329 | United States |
| Columbus Research Foundation | Columbus | Georgia | 31904 | United States |
| Eastside Bariatric and Gen Surg | Snellville | Georgia | 30078 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Synexus Clinical Research US Inc.-Chicago | Chicago | Illinois | 60602 | United States |
| Indiana University Hospital | Indianapolis | Indiana | 46505 | United States |
| University Of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Pennington Biom Res Ctr | Baton Rouge | Louisiana | 70808 | United States |
| Barry J. Reiner, MD LLC | Baltimore | Maryland | 21229 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| Mississippi CTR for ADV MED | Madison | Mississippi | 39110 | United States |
| UBMD Peds-Div of Endo/Diabetes | Buffalo | New York | 14203 | United States |
| WakeMed Childn Endo-Dbt_Raleig | Raleigh | North Carolina | 27610 | United States |
| Valley Weight Loss Clinic | Fargo | North Dakota | 58104 | United States |
| Centricity Research - Ohio | Columbus | Ohio | 43213 | United States |
| PriMed Clinical Research | Dayton | Ohio | 45429 | United States |
| UPMC Child Hosp-Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Coastal Carolina Research Ctr | North Charleston | South Carolina | 29405 | United States |
| Clinical Neuroscience Solutions | Memphis | Tennessee | 38119 | United States |
| Texas Diabetes Institute | San Antonio | Texas | 78207-5209 | United States |
| Clinical Trials of Texas Inc | San Antonio | Texas | 78229 | United States |
| Health Res of Hampton Roads | Newport News | Virginia | 23606 | United States |
| Virginia Commonwealth Univ | Richmond | Virginia | 23298 | United States |
| UZ Brussel - Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UZA - Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Uz Leuven | Leuven | 3000 | Belgium |
| Alberta Children's Hospital | Calgary | Alberta | T3B6A8 | Canada |
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| BC Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| Markham Stouffville Hosp | Markham | Ontario | L3P 7P3 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| McMaster Children's Hospital | West Hamilton | Ontario | L8N 3Z5 | Canada |
| Maison de Sante Prevention | Montreal | Quebec | H2J 1K1 | Canada |
| McGill Uni Health Ctre - Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Aarhus Universitetshospital, Steno Diabetes Center Aarhus | Aarhus | 8200 | Denmark |
| Aalborg Universitetshospital - Børne og Ungeafdelingen | Gistrup | 9260 | Denmark |
| Holbæk Sygehus - Børne- og Ungeafdelingen | Holbæk | 4300 | Denmark |
| Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre | Lille | 59037 | France |
| Fondation Lenval Nice | Nice | 06200 | France |
| Ap-Hp_Hopital Armand Trousseau | Paris | 75012 | France |
| Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle | Rouen | 76031 | France |
| Hopital Des Enfants | Toulouse | 31059 | France |
| Kath. Klinikum Bochum gGmbH - Kinderklinik St. Josef-Hospital | Bochum | 44791 | Germany |
| Uni-Med. Göttingen - Klinik für Kinder- und Jugendmedizin | Göttingen | 37075 | Germany |
| Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin | Göttingen | 37075 | Germany |
| Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung | Hanover | 30173 | Germany |
| Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung | Hanover | 30173 | Germany |
| Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin | Leipzig | 04103 | Germany |
| Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin | Leipzig | 04103 | Germany |
| Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ) | Ulm | 89075 | Germany |
| Universitätsklinikum Ulm für Kinder- und Jugendmedizin | Ulm | 89075 | Germany |
| U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic | Athens | 12462 | Greece |
| P & A Kyriakou Childrens' Hospital - Department of Endocrinology Growth and Development | Goudi/Athens | 115-27 | Greece |
| General University of Patra - Paediatric Department | Pátrai | 26504 | Greece |
| 'Ippokrateio' General Hospital of Thessaloniki | Thessaloniki | 546-42 | Greece |
| Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic | Thessaloniki | 54642 | Greece |
| IRCCS Meyer Firenze | Florence | Tuscany | 50139 | Italy |
| Ospedale dei Bambini "Vittore Buzzi" | Milan | 20154 | Italy |
| Ospedale Pediatrico Bambino Gesu | Roma | 00165 | Italy |
| IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica | Trieste | 34137 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento | Verona | 37126 | Italy |
| CHRISTUS - Latam Hub Excellence and Innovation Center | Monterrey | Nuevo León | 64060 | Mexico |
| Centro de Estudios de Investigación Metabólicos y Cardio | Ciudad Madero | Tamaulipas | 89440 | Mexico |
| Consultorio de Endocrinología y Pediatría | Puebla City | 72190 | Mexico |
| Klinika Pediatrii, Endokrynologii, Diabetologii I chorób Metabolicznych, Uniwersyteckiego Szpitala Klinicznego in Wrocław | Wroclaw | Lower Silesian Voivodeship | 50-368 | Poland |
| Copernicus Podmiot Leczniczy Sp. z o.o. | Gdansk | 80-803 | Poland |
| Górnośląskie Centrum Zdrowia Dziecka Im. Św. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 SUM w Katowicach | Katowice | 40-752 | Poland |
| UMED Clinical Trials sp. z o.o. | Lodz | 92-213 | Poland |
| Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie | Rzeszów | 35-301 | Poland |
| ELIPSA - Elzbieta Lipska praktyka lekarska Osrodek Endokrynologii i Diabetologii Dzieciecej | Stanisławow Pierwszy Nieporet | 05-126 | Poland |
| Instytut ''Pomnik - Centrum Zdrowia Dziecka'' | Warsaw | 04-730 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko | Zabrze | 41-800 | Poland |
| King Abdulaziz Hospital-Al Ahsa-National Guard | Al Ahsa | 36428 | Saudi Arabia |
| National Guard Hospital - Jeddah | Jeddah | 22384 | Saudi Arabia |
| King Khaled University Hospital,King Saud Univ. Med. City | Riyadh | 12372 | Saudi Arabia |
| King Faisal Specialist Hospital & Research Centre, Riyadh | Riyadh | 12713 | Saudi Arabia |
| National Guard Hospital_Riyadh | Riyadh | 14611 | Saudi Arabia |
| Falu Lasarett - Barn- och ungdomsmedicinsk mottagning | Falun | 791 37 | Sweden |
| Hallands sjukhus Halmstad | Halmstad | 30233 | Sweden |
| Skåne US Malmö - Barnöverviktsenheten | Malmö | 205 02 | Sweden |
| Sundsvalls sjukhus - Barn- och ungdomsmed mott | Sundsvall | 85643 | Sweden |
| Uppsala universitetssjukhus | Uppsala | 75185 | Sweden |
| Birmingham Children's Hospital | Birmingham | B4 6NH | United Kingdom |
| University Hospitals Bristol & Weston NHS Foundation Trust | Bristol | BS2 8AE | United Kingdom |
| Leeds Children's Hospital | Leeds | LS1 3EX | United Kingdom |
| Alder Hey Children's Hospital | Liverpool | L12 2AP | United Kingdom |
| University College Hospital - Paediatric Services | London | NW1 1BU | United Kingdom |
| Sheffield Children's Hospital | Sheffield | S10 2TH | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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