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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-3808 | Other Identifier | World Health Organization (WHO) | |
| 2022-502922-41 | EudraCT Number |
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This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults.
The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Kids | Experimental | Participants in the age group 6 to less than (<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Group Teens | Experimental | Participants in the age group 12 to < 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Semaglutide will be administered subcutaneously once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Group Kids: Change in body mass index (BMI) | Measured in percentage (%) | From baseline (week 0) to week 68 |
| Measure | Description | Time Frame |
|---|---|---|
| Group Kids: Improvement in weight category | Measured as count of participants. Weight categories based on growth charts from Center for Disease Control (CDC).gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile. |
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Inclusion Criteria:
Exclusion Criteria:
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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 | ||
| Yale School of Medicine |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| Placebo | Drug | Placebo will be administered subcutaneously once-weekly. |
|
| From baseline (week 0) to week 68 |
| Group Teens: Change in BMI | Measured in % | From week 0 to week 68 |
| Group Kids and Group Teens: Change in BMI | Measured in % | From week 0 to week 104 |
| Group Teens: Improvement in weight category | Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile. | From week 0 to week 68 |
| Group Kids and Group Teens: Improvement in weight category | Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile. | From week 0 to week 104 |
| Group Kids and Group Teens: Change in body weight | Measured in percentage | From week 0 to week 68 |
| Group Kids and Group Teens: Change in body weight | Measured in percentage | From week 0 to week 104 |
| Group Kids and Group Teens: Change in body weight | Measured in kilograms (kg) | From week 0 to week 68 |
| Group Kids and Group Teens: Change in body weight | Measured in kilograms (kg) | From week 0 to week 104 |
| Group Kids and Group Teens: Change in BMI percentage of the 95th percentile | Measured in percentage points | From week 0 to week 68 |
| Group Kids and Group Teens: Change in BMI percentage of the 95th percentile | Measured in percentage points | From week 0 to week 104 |
| Group Kids and Group Teens: Change in BMI Standard deviation score (SDS) | Measured as score on a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. | From week 0 to week 68 |
| Group Kids and Group Teens: Change in BMI SDS | Measured as score in a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. | From week 0 to week 104 |
| Group Kids and Group Teens: Change in waist circumference | Measured in centimeters (cm) | From week 0 to week 68 |
| Group Kids and Group Teens: Change in waist circumference | Measured in centimeters (cm) | From week 0 to week 104 |
| Group Kids and Group Teens: Change in systolic blood pressure | Measured in millimeters of mercury (mmHg) | From week 0 to week 68 |
| Group Kids and Group Teens: Change in systolic blood pressure | Measured in millimeters of mercury (mmHg) | From week 0 to week 104 |
| Group Kids and Group Teens: Change in diastolic blood pressure | Measured in mmHg | From week 0 to week 68 |
| Group Kids and Group Teens: Change in diastolic blood pressure | Measured in mmHg | From week 0 to week 104 |
| Group Kids and Group Teens: Change in total cholesterol | Measured in % | From week 0 to week 68 |
| Group Kids and Group Teens: Change in total cholesterol | Measured in % | From week 0 to week 104 |
| Group Kids and Group Teens: Change in high density lipoprotein (HDL) | Measured in % | From week 0 to week 68 |
| Group Kids and Group Teens: Change in high density lipoprotein (HDL) | Measured in % | From week 0 to week 104 |
| Group Kids and Group Teens: Change in low density lipoprotein (LDL) | Measured in % | From week 0 to week 68 |
| Group Kids and Group Teens: Change in low density lipoprotein (LDL) | Measured in % | From week 0 to week 104 |
| Group Kids and Group Teens: Change in very low density lipoprotein (VLDL) | Measured in % | From week 0 to week 68 |
| Group Kids and Group Teens: Change in very low density lipoprotein (VLDL) | Measured in % | From week 0 to week 104 |
| Group Kids and Group Teens: Change in triglycerides | Measured in % | From week 0 to week 68 |
| Group Kids and Group Teens: Change in triglycerides | Measured in % | From week 0 to week 104 |
| Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP) | Measured in % | From week 0 to week 68 |
| Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP) | Measured in % | From week 0 to week 104 |
| Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c) | Measured in % point | From week 0 to week 68 |
| Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c) | Measured in % point | From week 0 to week 104 |
| Group Kids and Group Teens: Change in fasting plasma glucose | Measured in millimoles per liter (mmol/L) | From week 0 to week 68 |
| Group Kids and Group Teens: Change in fasting plasma glucose | Measured in millimoles per liter (mmol/L) | From week 0 to week 104 |
| Group Kids and Group Teens: Change in fasting plasma glucose | Measured in milligrams per deciliter (mg/dL) | From week 0 to week 68 |
| Group Kids and Group Teens: Change in fasting plasma glucose | Measured in milligrams per deciliter (mg/dL) | From week 0 to week 104 |
| Group Kids and Group Teens: Change in fasting insulin | Measured in % | From week 0 to week 68 |
| Group Kids and Group Teens: Change in fasting insulin | Measured in % | From week 0 to week 104 |
| Group Kids and Group Teens: Change in alanine transaminase (ALT) | Measured in milliunits per liter (mU/L) | From week 0 to week 68 |
| Group Kids and Group Teens: Change in alanine transaminase (ALT) | Measured in milliunits per liter (mU/L) | From week 0 to week 104 |
| Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass | Measured in % points | From week 0 to week 68 |
| Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass | Measured in % points | From week 0 to week 104 |
| Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass | Measured in % points | From week 0 to week 68 |
| Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass | Measured in % points | From week 0 to week 104 |
| Group Kids and Group Teens: Relative change in visceral fat mass by DXA | Measured in % | From week 0 to week 68 |
| Group Kids and Group Teens: Relative change in visceral fat mass by DXA | Measured in % | From week 0 to week 104 |
| Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 68 |
| Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 104 |
| Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 68 |
| Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 104 |
| Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 68 |
| Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 104 |
| Group Kids and Group Teens: Number of treatment emergent adverse events (AEs) | Measured as count of events | From week 0 to week 68 |
| Group Kids and Group Teens: Number of treatment emergent adverse events (AEs) | Measured as count of events | From week 0 to week 111 |
| Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs) | Measured as count of events | From week 0 to week 68 |
| Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs) | Measured as count of events | From week 0 to week 111 |
| Group Kids and Group Teens: Change in pulse | Measured as beats per minute | From week 0 to week 68 |
| Group Kids and Group Teens: Change in pulse | Measured as beats per minute | From week 0 to week 104 |
| Group Kids and Group Teens: Change in amylase | Measured as units per liter (U/L) | From week 0 to week 68 |
| Group Kids and Group Teens: Change in amylase | Measured as units per liter (U/L) | From week 0 to week 104 |
| Group Kids and Group Teens: Change in lipase | Measured as U/L | From week 0 to week 68 |
| Group Kids and Group Teens: Change in lipase | Measured as U/L | From week 0 to week 104 |
| Group Kids and Group Teens: Change in calcitonin | Measured as nanograms per liter (ng/L) | From week 0 to week 68 |
| Group Kids and Group Teens: Change in calcitonin | Measured as nanograms per liter (ng/L) | From week 0 to week 104 |
| Group Kids and Group Teens: Change in bone mineral density, by DXA | Measured as grams per square centimeter (g/cm^2) | From week 0 to week 68 |
| Group Kids and Group Teens: Change in bone mineral density, by DXA | Measured as grams per square centimeter (g/cm^2) | From week 0 to week 104 |
| Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only) | Measured as count of episodes | From week 0 to week 68 |
| Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only) | Measured as count of episodes | From week 0 to week 111 |
| New Haven |
| Connecticut |
| 06519 |
| 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 |
| Pennington Biom Res Ctr | Baton Rouge | Louisiana | 70808 | United States |
| Clinical Trials of America LLC | Monroe | Louisiana | 71201 | United States |
| IMA Clinical Research | Monroe | Louisiana | 71201 | United States |
| Barry J. Reiner, MD LLC | Baltimore | Maryland | 21229 | United States |
| Massachusetts General Hospital_Cary | Boston | Massachusetts | 02114 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| Mississippi Center for Advanced Medicine | Madison | Mississippi | 39110 | 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 |
| UPMC Child Hosp-Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Pediatric Clinical Trials, LLC | Tullahoma | Tennessee | 37388 | United States |
| Texas Diabetes & Endocrinology | Austin | Texas | 78731 | United States |
| Univ Of Texas Hlth Science Cntr | San Antonio | Texas | 78207 | United States |
| Health Res of Hampton Roads | Newport News | Virginia | 23606 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Universitätsklinik Kinder-Jugendheilkunde Innsbruck | Innsbruck | 6020 | Austria |
| Universitätsklinik für Kinder und Jugendheilkunde Haus E | Salzburg | 5020 | Austria |
| UZ Brussel | Brussels | 1090 | Belgium |
| UZ Antwerpen - UZA - Kinderziekenhuis | Edegem | 2650 | Belgium |
| UZA - UZ Antwerpen - Kinderziekenhuis | Edegem | 2650 | Belgium |
| UZ Leuven - Kindergeneeskunde | Leuven | 3000 | Belgium |
| 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 |
| Universitätsklinikum Halle - Innere Medizin II | Halle | 06120 | Germany |
| Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung | Hanover | 30173 | Germany |
| Kinder- und Jugendkrankenhaus | 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 |
| Rambam MC - Department of Pediatrics A | Haifa | 31096 | Israel |
| Schneider MC - Endrocrinology and Diabetes | Petah Tikva | 49202 | Israel |
| Shamir MC - Pediatric and Adolescents Endocrinology unit | Ẕerifin | 7033001 | Israel |
| Consultorio de Endocrinología y Pediatría | Puebla City | 72190 | Mexico |
| Hospital da Luz Lisboa, S.A. | Lisbon | 1500-650 | Portugal |
| ULS De Santo António, E.P.E. - Hospital de Santo António | Porto | 4050-342 | Portugal |
| Hospital CUF Porto S.A. | Porto | 4100-180 | Portugal |
| Drottning Silvias barnsjukhus | Gothenburg | 41650 | Sweden |
| Hallands sjukhus Halmstad | Halmstad | 30233 | Sweden |
| Akademiska sjukhuset Uppsala | Uppsala | 75185 | Sweden |
| Uppsala universitetssjukhus | Uppsala | 75185 | Sweden |
| Birmingham Children's Hospital | Birmingham | B4 6NH | United Kingdom |
| University Hospitals Bristol & Weston NHS Foundation Trust | Bristol | BS2 8BJ | United Kingdom |
| Leeds Children's Hospital | Leeds | LS1 3EX | United Kingdom |
| Alder Hey Children's Hospital | Liverpool | L12 2AP | 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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