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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1299-4751 | Other Identifier | World Health Organization (WHO) | |
| 2023-509176-42 | Other Identifier | European Medical Agency (EMA) |
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This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema | Experimental | Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks and further continue to receive the same dose or maximum tolerated dose (MTD) in the open-label extension phase for up to 156 weeks. |
|
| Semaglutide | Experimental | Participants will receive once weekly s.c. dose of semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. |
|
| Cagrilintide | Experimental | Participants will receive once weekly s.c. dose of cagrilintide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks, further continue to receive the same dose as the dose escalation regimen or MTD in the open-label extension phase for up to 156 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. Participants will further continue to receive the same dose escalation regimen as CagriSema for 16 weeks, later continue to receive the same dose or MTD in the open-label extension phase for up to 140 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Participants will receive cagrilintide subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body mass index (BMI) | Measured in percentage (%). | Baseline (week 0), week 68 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured in %. | Baseline (week 0), week 68 |
| Change in BMI Standard Deviation Score (SDS) | Measured as SDS score. |
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Inclusion criteria:
For participants with T2D at screening the following inclusion criteria also apply
Key exclusion criteria:
For participants with T2D at screening the following exclusion criteria also apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neighborhood Healthcare | Not yet recruiting | Escondido | California | 92025 | United States | |
According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.
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Sponsor staff involved in the clinical trial is masked according to company standard procedures. The main phase of the study is double blinded and followed by an open label extension phase.
|
| Semaglutide | Drug | Participants will receive semaglutide subcutaneously. |
|
| Placebo cagrilintide | Drug | Participants will receive placebo matched to cagrilintide subcutaneously. |
|
| Placebo semaglutide | Drug | Participants will receive placebo matched to semaglutide subcutaneously. |
|
| Baseline (week 0), week 68 |
| Relative change in BMI | Measured in %. | Baseline (week 0), week 68 and week 224 |
| Number of participants in weight category reduction | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved >=10% reduction of body weight (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved >=15% reduction of body weight (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved >=20% reduction of body weight (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved >=25% reduction of body weight (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved >=5% reduction of BMI (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved >=10% reduction of BMI (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved >=15% reduction of BMI (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved >=20% reduction of BMI (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved >=25% reduction of BMI (yes/no) | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who achieved normal BMI | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants who shifted from obese to non-obese BMI class | Measured as count of participants. | Baseline (week 0), week 68 |
| Change in waist circumference | Measured in centimeter (cm). | Baseline (week 0), week 68 and week 224 |
| Change in waist-to-height ratio | Measured as ratio. | Baseline (week 0), week 68 |
| Absolute change in total fat mass by dual energy X-ray absorption (DXA) | Measured in kilograms (kg). | Baseline (week 0), week 68 |
| Relative to baseline change in total fat mass by DXA | Measured in %. | Baseline (week 0), week 68 |
| Relative to total body mass change in total fat mass by DXA | Measured in % points. | Baseline (week 0), week 68 |
| Absolute change in visceral fat mass by DXA | Measured in kg. | Baseline (week 0), week 68 |
| Relative to baseline change in visceral fat mass by DXA | Measured in %. | Baseline (week 0), week 68 |
| Relative to total body mass change in visceral fat mass by DXA | Measured in % points. | Baseline (week 0), week 68 |
| Absolute change in lean body mass by DXA | Measured in kg. | Baseline (week 0), week 68 |
| Relative to total body mass change in lean body mass by DXA | Measured in % points. | Baseline (week 0), week 68 |
| Absolute change in total (neck-to-knee) muscle and fat volumes by Magnetic Resonance Imaging (MRI) - total muscle and total fat | Measured in liters (L). | Baseline (week 0), week 68 and week 224 |
| Relative to baseline change in total (neck-to-knee) muscle and fat volumes by MRI - total muscle and total fat | Measured in %. | Baseline (week 0), week 68 and week 224 |
| Change in ectopic fat content by MRI - liver fat MRI-Proton Density Fat Fraction (MRI-PDFF), pancreatic fat, kidney fat and thigh muscle fat infiltration | Measured in % points. | Baseline (week 0), week 68 and week 224 |
| Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat | Measured in liters. | Baseline (week 0), week 68 and week 224 |
| Relative to baseline change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat | Measured in %. | Baseline (week 0), week 68 and week 224 |
| Absolute change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat | Measured in liters. | Baseline (week 0), week 68 and week 224 |
| Relative to baseline change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat | Measured in %. | Baseline (week 0), week 68 and week 224 |
| Ratio to baseline in liver stiffness measured by Magnetic Resonance Elastography (MRE) | Measured as ratio. | Baseline (week 0), week 68 and week 224 |
| Change in BMI percentage of the 95th percentile | Measured in % points. | Baseline (week 0), week 68 |
| Ratio to baseline highly sensitive C-reactive protein (hs-CRP) | Measured as ratio. | Baseline (week 0), week 68 |
| Ratio to baseline in lipids: Total cholesterol | Measured as ratio. | Baseline (week 0), week 68 and week 224 |
| Ratio to baseline in lipids: High Density Lipoprotein (HDL) cholesterol | Measured as ratio. | Baseline (week 0), week 68 and week 224 |
| Ratio to baseline in lipids: Low Density Lipoprotein (LDL) cholesterol | Measured as ratio. | Baseline (week 0), week 68 and week 224 |
| Ratio to baseline in lipids: Very Low Density Lipoprotein (VLDL) cholesterol | Measured as ratio. | Baseline (week 0), week 68 and week 224 |
| Ratio to baseline in lipids: Triglycerides | Measured as ratio. | Baseline (week 0), week 68 and week 224 |
| Ratio to baseline in lipids: Non-HDL cholesterol | Measured as ratio. | Baseline (week 0), week 68 and week 224 |
| Change in Alanine Transaminase (ALT) | Measured in Units per Liter (U/L). | Baseline (week 0), week 68 and week 224 |
| Change in systolic blood pressure | Measured in millimeters of mercury (mmHg). | Baseline (week 0), week 68 and week 224 |
| Change in diastolic blood pressure | Measured in mmHg. | Baseline (week 0), week 68 and week 224 |
| Ratio to baseline in liver stiffness measured by ultrasonographic methods | Measured as ratio. | Baseline (week 0), week 68 and week 224 |
| Change in glycated haemoglobin (HbA1c) (% points) | Measured in % points. | Baseline (week 0), week 68 and week 224 |
| Change in HbA1c (millimoles per mole [mmol/mol]) | Measured in mmol/mol. | Baseline (week 0), week 68 and week 224 |
| Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L]) | Measured in mmol/L. | Baseline (week 0), week 68 |
| Change in FPG (milligrams per deciliter [mg/dL]) | Measured in mg/dL. | Baseline (week 0), week 68 |
| Ratio to baseline in fasting serum insulin | Measured as ratio. | Baseline (week 0), week 68 and week 224 |
| Number of participants with prediabetes who achieved HbA1c less than (<) 5.7% (defined as 5.7 % less than or equal to [<=] HbA1c <6.5 %) at baseline | Measured as count of participants. | At week 68 |
| Number of participants with normoglycemia (defined as HbA1c < 5.7 %) at baseline, development of HbA1c greater than or equal to (>=) 5.7 % | Measured as count of participants. | At week 68 |
| Number of participants with prediabetes (5.7 % <= HbA1c < 6.5 %) at baseline, development of HbA1c >= 6.5% | Measured as count of participants. | At week 68 |
| Number of participants with HbA1c >=6.5% at baseline, achievement of HbA1c <6.5% | Measured as count of participants. | At week 68 |
| Number of participants taking glucose lowering medication at baseline, stop or decrease | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants taking antihypertensive medication at baseline, stop or decrease | Measured as count of participants. | Baseline (week 0), week 68 |
| Number of participants taking lipid lowering medication at baseline, stop or decrease | Measured as count of participants. | Baseline (week 0), week 68 |
| Impact of Weight on Quality of Life-Kids (IWQOL Kids) - Physical comfort domain score | Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). | Baseline (week 0), week 68 and week 224 |
| IWQOL Kids - Body esteem domain score | Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). | Baseline (week 0), week 68 and week 224 |
| IWQOL Kids - Social life domain score | Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). | Baseline (week 0), week 68 and week 224 |
| IWQOL Kids - Family-relations score | Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). | Baseline (week 0), week 68 and week 224 |
| IWQOL Kids - Total score | Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). | Baseline (week 0), week 68 and week 224 |
| Control of Eating Questionnaire (COEQ) | Measured as score points. CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control. | Baseline (week 0), week 68 and week 224 |
| Change in proteomics-based serum biomarkers including biomarkers for metabolic dysfunction-associated steatohepatitis (MASH) | Measured as counts. | Baseline (week 0), week 68 and week 224 |
| Number of treatment-emergent adverse events (TEAEs) | Measured as count of events. | Baseline (week 0), week 68 and week 224 |
| Number of treatment-emergent serious adverse events (TESAEs) | Measured as count of events. | Baseline (week 0), week 68 and week 224 |
| Number of treatment-emergent hypoglycaemic episodes | Measured as count of events. | Baseline (week 0), week 68 and week 224 |
| Change in pulse rate | Measured in beats per minute (beats/min). | Baseline (week 0), week 68 |
| Change in calcitonin | Measured in nanograms per liter (ng/L). | Baseline (week 0), week 68 |
| Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state | Measured in liters per hour (L/h). | Baseline (week 0), week 68 |
| Average concentration (Cavg) of semaglutide and cagrilintide at steady state | Measured in nanomoles per liter (nmol/L). | Baseline (week 0), week 68 |
| Area under the steady-state concentration-time curves (AUCt) in the dosing interval of semaglutide and cagrilintide | Measured in hours nanomoles per liter (h·nmol/L). | Baseline (week 0), week 68 |
| Encore Medical Research LLC |
| Recruiting |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Jacksonville Ctr for Clin Res | Not yet recruiting | Jacksonville | Florida | 32216 | United States |
| Encore Medical Research of Weston | Recruiting | Weston | Florida | 33331 | United States |
| Children's Healthcare Atlanta | Recruiting | Atlanta | Georgia | 30329 | United States |
| Columbus Research Foundation | Recruiting | Columbus | Georgia | 31904 | United States |
| Accel Research Sites-NeuroStudies | Recruiting | Decatur | Georgia | 30030 | United States |
| Eastside Bariatric and Gen Surg | Recruiting | Snellville | Georgia | 30078 | United States |
| Solaris Clinical Research | Not yet recruiting | Meridian | Idaho | 83646 | United States |
| IU Health - Riley Physicians Endo-Diab | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Cotton O'Neil Clinical Research Center | Not yet recruiting | Topeka | Kansas | 66606 | United States |
| Pennington Biomed Res Ctr | Recruiting | Baton Rouge | Louisiana | 70808-4124 | United States |
| Barry J. Reiner, MD LLC | Not yet recruiting | Baltimore | Maryland | 21229 | United States |
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| AES Minneapolis DRS | Not yet recruiting | Richfield | Minnesota | 55423 | United States |
| UBMD Physicians Group - Pediatrics - Conventus | Not yet recruiting | Buffalo | New York | 15203 | United States |
| SUNY Upstate Medical Univ - Syracuse | Not yet recruiting | Syracuse | New York | 13210 | United States |
| Advantage Clinical Trials | Not yet recruiting | The Bronx | New York | 10467 | United States |
| Valley Weight Loss Clinic | Not yet recruiting | Fargo | North Dakota | 58104 | United States |
| Centricity Research - Ohio | Not yet recruiting | Columbus | Ohio | 43213 | United States |
| PriMed Clinical Research | Not yet recruiting | Dayton | Ohio | 45429 | United States |
| Children's Physicians OU | Not yet recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| UPMC Child Hosp-Pittsburgh | Not yet recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
| Prisma Health-Ped Endo | Not yet recruiting | Greenville | South Carolina | 29615 | United States |
| Coastal Carolina Research Ctr | Not yet recruiting | North Charleston | South Carolina | 29405 | United States |
| Monument Health Clinical Rsrch | Not yet recruiting | Rapid City | South Dakota | 57701 | United States |
| LifeDoc Health | Not yet recruiting | Memphis | Tennessee | 38115 | United States |
| DM Clinical | Recruiting | Houston | Texas | 77065 | United States |
| DM Clinical | Not yet recruiting | San Antonio | Texas | 78207 | United States |
| The Texas Liver Institute | Not yet recruiting | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research | Not yet recruiting | San Antonio | Texas | 78229 | United States |
| Consano Clin Res-Shavano Park | Not yet recruiting | Shavano Park | Texas | 78231 | United States |
| Texas Valley Clinical Research | Not yet recruiting | Weslaco | Texas | 78596 | United States |
| Wee Care Pediatrics | Not yet recruiting | Syracuse | Utah | 84075 | United States |
| The Children's Hospital at Westmead - Clinical Research Centre | Recruiting | Westmead | New South Wales | 2145 | Australia |
| Queensland Children's Hospital | Recruiting | South Brisbane | Queensland | 4101 | Australia |
| Perth Children's Hospital | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| Universitätsklinik Kinder-Jugendheilkunde Innsbruck | Not yet recruiting | Innsbruck | 6020 | Austria |
| Universitätsklinik für Kinder und Jugendheilkunde Haus E | Not yet recruiting | Salzburg | 5020 | Austria |
| UZ Brussel - Universitair Ziekenhuis Brussel | Not yet recruiting | Brussels | 1090 | Belgium |
| UZA - UZ Antwerpen - Kinderziekenhuis | Not yet recruiting | Edegem | 2650 | Belgium |
| UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics | Not yet recruiting | Plovdiv | 4002 | Bulgaria |
| SHATPD - Prof. Ivan Mitev EAD | Not yet recruiting | Sofia | 1606 | Bulgaria |
| Medical center Children's Health EOOD | Not yet recruiting | Sofia | 1618 | Bulgaria |
| UMHAT Sveta Marina EAD, First Pediatric Clinic | Not yet recruiting | Varna | 9010 | Bulgaria |
| Capital Center for Children's Health, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100020 | China |
| Beijing Children's Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100045 | China |
| Henan Children's Hospital Zhengzhou Children's Hospital | Not yet recruiting | Zhengzhou | Henan | 450018 | China |
| Wuhan Children Hospital | Not yet recruiting | Wuhan | Hubei | 430019 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
| The First Bethune Hospital of Jilin University-Pediatric | Not yet recruiting | Changchun | Jilin | 130021 | China |
| Shandong Provincial Hospital-Pediatric | Not yet recruiting | Jinan | Shandong | 250098 | China |
| Children's Hospital of Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 201102 | China |
| Chengdu Women's and Children's Central Hospital | Not yet recruiting | Chengdu | Sichuan | 610031 | China |
| Servicios de Salud Ips Suramericana S.A.S. | Not yet recruiting | Medellín | Antioquia | 05001 | Colombia |
| Fundación Santa Fe de Bogotá | Not yet recruiting | Bogotá | 110111 | Colombia |
| Clinical Hospital Centre Rijeka_Pediatric | Not yet recruiting | Rijeka | 51 000 | Croatia |
| KBC "Sestre Milosrdnice" | Not yet recruiting | Zagreb | 10 000 | Croatia |
| Klinika Za Djecje Bolesti Zagreb_Endocrinology | Not yet recruiting | Zagreb | 10000 | Croatia |
| Aalborg Universitetshospital - Børne og Ungeafdelingen | Not yet recruiting | Aalborg | 9000 | Denmark |
| Holbæk Sygehus - Børne- og Ungeafdelingen | Not yet recruiting | Holbæk | 4300 | Denmark |
| Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő | Not yet recruiting | Budapest | 1023 | Hungary |
| Semmelweis Egyetem ÁOK | Not yet recruiting | Budapest | 1083 | Hungary |
| Szegedi Tudományegyetem Gyermekgyógyászati Klinika | Not yet recruiting | Szeged | 6720 | Hungary |
| Endolife Specialty Hospitals | Not yet recruiting | Guntur | Andhra Pradesh | 522001 | India |
| BAPS Pramukh Swami Hospital | Not yet recruiting | Surat | Gujarat | 395009 | India |
| Indira Gandhi Institute of child health | Not yet recruiting | Bangalore | Karnataka | 560011 | India |
| Sir Ganga Ram Hospital | Not yet recruiting | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Maulana Azad Medical College | Not yet recruiting | Delhi | New Delhi | 110002 | India |
| Regency Hospital | Not yet recruiting | Kanpur | Uttar Pradesh | 208006 | India |
| Institute of Child Health | Not yet recruiting | Kolkata | West Bengal | 700017 | India |
| Excel Endocrine Centre | Not yet recruiting | Kolhāpur | 416008 | India |
| All India Institute of Medical Sciences (AIIMS) | Not yet recruiting | New Delhi | 110029 | India |
| Rambam MC - Department of Pediatrics A | Not yet recruiting | Haifa | 31096 | Israel |
| Schneider MC - Endrocrinology and Diabetes | Not yet recruiting | Petah Tikva | 49202 | Israel |
| Shamir MC - Pediatric and Adolescents Endocrinology unit | Not yet recruiting | Ẕerifin | 7033001 | Israel |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia | Not yet recruiting | Milan | Lombardy | 20122 | Italy |
| AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria | Not yet recruiting | Novara | Piedmont | 28100 | Italy |
| IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica | Not yet recruiting | Trieste | 34137 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento | Not yet recruiting | Verona | 37126 | Italy |
| Hospital Tunku Azizah | Not yet recruiting | Kampung Baru | Kuala Lumpur | 50300 | Malaysia |
| University Malaya Medical Centre | Not yet recruiting | Lembah Pantai | Kuala Lumpur | 59100 | Malaysia |
| Hospital Sibu | Not yet recruiting | Sibu | Sarawak | 96000 | Malaysia |
| CHRISTUS - Latam Hub Excellence and Innovation Center | Not yet recruiting | Monterrey | Nuevo León | 64060 | Mexico |
| IECSI Centro de Investigación Clínica | Not yet recruiting | Monterrey | Nuevo León | 64310 | Mexico |
| Consultorio de Endocrinología y Pediatría | Not yet recruiting | Puebla City | 72190 | Mexico |
| Jeroen Bosch Zkh | Not yet recruiting | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Meander MC | Completed | Amersfoort | 3813 TZ | Netherlands |
| Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym | Not yet recruiting | Dziekanów Leśny | 05-092 | Poland |
| Uniwersytecki Szpital Kliniczny w Opolu | Not yet recruiting | Opole | 45-401 | Poland |
| Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie | Not yet recruiting | Rzeszów | 35-301 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko | Not yet recruiting | Zabrze | 41-800 | Poland |
| ULS De Santo António, E.P.E. - Hospital de Santo António | Not yet recruiting | Porto | 4050-342 | Portugal |
| Hospital CUF Porto S.A. | Not yet recruiting | Porto | 4100-180 | Portugal |
| ULS De Gaia/Espinho E.P.E. - Hospital Eduardo Santos Silva | Not yet recruiting | Vila Nova de Gaia | 4434-502 | Portugal |
| Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare | Not yet recruiting | Baia Mare | 430031 | Romania |
| Kilostop Junior SRL | Not yet recruiting | Bucharest | 010073 | Romania |
| Spitalul Clinic de Urgenta pentru Copii "M.S.Curie" | Not yet recruiting | Bucharest | 041451 | Romania |
| Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara | Not yet recruiting | Timișoara | 300226 | Romania |
| University Children's Hospital Tirsova | Not yet recruiting | Belgrade | 11000 | Serbia |
| Institute for Mother and Child Health Care of Serbia | Not yet recruiting | Belgrade | 11070 | Serbia |
| Institute for Health Care of Children and Adolescents | Not yet recruiting | Novi Sad | 21000 | Serbia |
| Narodny Ustav Detskych Chorob | Not yet recruiting | Bratislava | 833 40 | Slovakia |
| Detska Fakultna nemocnica Kosice | Not yet recruiting | Košice | 040 01 | Slovakia |
| Narodny Endokrinologicky a diabetologicky ustav | Not yet recruiting | Ľubochňa | 03491 | Slovakia |
| Hospital Vall d'Hebrón_Endocrinología pediatríca | Not yet recruiting | Barcelona | 08035 | Spain |
| Hospital Sant Joan de Déu | Not yet recruiting | Esplugues de Llobregat | 08950 | Spain |
| Hospital Universitario Virgen del Rocío | Not yet recruiting | Seville | 41013 | Spain |
| Barn och ungdomscentrum Västerbotten - NU | Not yet recruiting | Umeå | 907 37 | Sweden |
| Uppsala universitetssjukhus | Not yet recruiting | Uppsala | 75185 | Sweden |
| Chang Gung Memorial Hospital - Kaohsiung Branch | Not yet recruiting | Kaohsiung City | 833 | Taiwan |
| Chung Shan Medical University Hospital | Not yet recruiting | Taichung | 402 | Taiwan |
| Taipei Mackay Children's Hospital | Not yet recruiting | Taipei | 104 | Taiwan |
| Chang Gung Memorial Hospital Linkou-Dept of Pediatrics | Not yet recruiting | Taoyuan | 333 | Taiwan |
| King Chulalongkorn Memorial Hospital_Ped-Nutrition | Not yet recruiting | Bangkok | 10300 | Thailand |
| Thammasat Hospital_CRC | Not yet recruiting | Pathum Thani | 12120 | Thailand |
| Birmingham Children's Hospital | Recruiting | Birmingham | B4 6NH | United Kingdom |
| Alder Hey Children's Hospital | Recruiting | Liverpool | L12 2AP | United Kingdom |
| University College Hospital - Paediatric Services | Recruiting | London | NW1 1BU | United Kingdom |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
Not provided
Not provided
Not provided