Phase
Condition
Obesity
Diabetes Prevention
Treatment
Placebo
Semaglutide
Clinical Study ID
Ages 6-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent of parent(s) or legally acceptable representative (LAR) ofparticipant and child assent, as age-appropriate, obtained before any study-relatedactivities. Study-related activities are any procedures that are carried out as partof the study, including activities to determine suitability for the study. a) Theparents or LAR of the child must sign and date the Informed Consent Form (accordingto local requirements) b) The child must sign and date the Child Assent Form orprovide oral assent (according to local requirements)
Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years.b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1
Body mass index (BMI), at screening and randomisation, corresponding to a) GroupKids: greater than or equal to 95th percentile. b) Group Teens: greater than orequal to 95th percentile or greater than or equal to 85th percentile with thepresence of at least 1 weight-related comorbidity (treated or untreated):hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (T2D)
History of at least one unsuccessful effort to lose sufficient body weight afterparticipation in a structured lifestyle modification programme (diet and exercisecounselling) for at least 3 months
Body weight of greater than 45 kilogram (kg) at screening and randomisation
For participants with T2D at screening, the following additional criterion applies:glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles permole [mmol/mol]) as measured by central laboratory at screening
Exclusion
Exclusion Criteria:
Treatment with any medication prescribed for the indication of obesity or weightmanagement within 90 days before screening
Previous or planned (during the study period) obesity treatment with surgery or aweight loss device. However, the following are allowed: a) liposuction and/orabdominoplasty, if performed greater than 1 year prior to screening. b) adjustablegastric banding, if the band has been removed greater than 1 year prior toscreening. c) intragastric balloon, if the balloon has been removed greater than 1year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if thesleeve has been removed greater than 1 year prior to screening
Type 1 diabetes mellitus or monogenic diabetes
Participants with endocrine, hypothalamic, or syndromic obesity
For participants with T2D at screening, the following additional key criterionapplies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.Verified by a fundus examination performed within the past 90 days before screeningor in the period between screening and randomisation. Pharmacological pupil-dilationis a requirement unless using a digital fundus photography camera specified fornon-dilated examination
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Innsbruck, 6020
AustriaActive - Recruiting
Universitätsklinik Kinder-Jugendheilkunde
Innsbruck, 6020
AustriaActive - Recruiting
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
Innsbruck, 6020
AustriaSite Not Available
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
Innsbruck 2775220, 6020
AustriaSite Not Available
Novo Nordisk Investigational Site
Salzburg, 5020
AustriaSite Not Available
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg, 5020
AustriaSite Not Available
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg 2766824, 5020
AustriaSite Not Available
Novo Nordisk Investigational Site
Brussel, 1090
BelgiumActive - Recruiting
UZ Brussel
Brussel, 1090
BelgiumSite Not Available
UZ Brussel
Brussels 2800866, 1090
BelgiumSite Not Available
Novo Nordisk Investigational Site
Edegem, 2650
BelgiumActive - Recruiting
UZ Antwerpen - UZA - Kinderziekenhuis
Edegem, 2650
BelgiumSite Not Available
UZA - UZ Antwerpen - Kinderziekenhuis
Edegem, 2650
BelgiumSite Not Available
UZ Antwerpen - UZA - Kinderziekenhuis
Edegem 2799007, 2650
BelgiumSite Not Available
UZA - UZ Antwerpen - Kinderziekenhuis
Edegem 2799007, 2650
BelgiumSite Not Available
Novo Nordisk Investigational Site
Leuven, 3000
BelgiumActive - Recruiting
UZ Leuven - Kindergeneeskunde
Leuven, 3000
BelgiumSite Not Available
UZ Leuven - Kindergeneeskunde
Leuven 2792482, 3000
BelgiumSite Not Available
Aalborg Universitetshospital
Aalborg, 9000
DenmarkSite Not Available
Novo Nordisk Investigational Site
Aalborg, 9000
DenmarkSite Not Available
Aalborg Universitetshospital
Aalborg 2624886, 9000
DenmarkSite Not Available
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus, 8200
DenmarkSite Not Available
Novo Nordisk Investigational Site
Aarhus, 8200
DenmarkActive - Recruiting
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus 2624652, 8200
DenmarkSite Not Available
Holbæk Sygehus
Holbæk, 4300
DenmarkSite Not Available
Novo Nordisk Investigational Site
Holbæk, 4300
DenmarkSite Not Available
Holbæk Sygehus
Holbæk 2620147, 4300
DenmarkSite Not Available
Holbæk Sygehus - Børne- og Ungeafdelingen
Holbæk 2620147, 4300
DenmarkSite Not Available
Novo Nordisk Investigational Site
Halle, 06120
GermanySite Not Available
Universitätsklinikum Halle (Saale)
Halle, 06120
GermanySite Not Available
Universitätsklinikum Halle - Innere Medizin II
Halle 2911522, 06120
GermanySite Not Available
Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
Hannover, 30173
GermanySite Not Available
Kinder- und Jugendkrankenhaus
Hannover, 30173
GermanySite Not Available
Novo Nordisk Investigational Site
Hannover, 30173
GermanySite Not Available
Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung
Hanover 2910831, 30173
GermanySite Not Available
Kinder- und Jugendkrankenhaus
Hanover 2910831, 30173
GermanySite Not Available
Novo Nordisk Investigational Site
Leipzig, 04103
GermanySite Not Available
Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
Leipzig, 04103
GermanySite Not Available
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin
Leipzig, 04103
GermanySite Not Available
Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
Leipzig 2879139, 04103
GermanySite Not Available
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin
Leipzig 2879139, 04103
GermanySite Not Available
Novo Nordisk Investigational Site
Ulm, 89075
GermanySite Not Available
Universitätsklinikum Ulm für Kinder- und Jugendmedizin
Ulm, 89075
GermanySite Not Available
Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
Ulm 2820256, 89075
GermanySite Not Available
Universitätsklinikum Ulm für Kinder- und Jugendmedizin
Ulm 2820256, 89075
GermanySite Not Available
Novo Nordisk Investigational Site
Haifa, 31096
IsraelActive - Recruiting
Rambam Medical Center Children A Dept.
Haifa, 31096
IsraelSite Not Available
Rambam MC - Department of Pediatrics A
Haifa 294801, 31096
IsraelSite Not Available
Endrocrinology & DM Schneider MC
Petah Tikva, 49202
IsraelSite Not Available
Novo Nordisk Investigational Site
Petah Tikva, 49202
IsraelActive - Recruiting
Schneider MC - Endrocrinology and Diabetes
Petah Tikva 293918, 49202
IsraelSite Not Available
Novo Nordisk Investigational Site
Zerifin, 70300
IsraelActive - Recruiting
Shamir (Assaf Harofe) Medical Center
Zerifin, 7033001
IsraelSite Not Available
Shamir MC - Cardio and Pedi
Ẕerifin 293084, 7033001
IsraelSite Not Available
Shamir MC - Pediatric and Adolescents Endocrinology unit
Ẕerifin 293084, 7033001
IsraelSite Not Available
Consultorio de Endocrinología y Pediatría
Puebla, 72190
MexicoSite Not Available
Novo Nordisk Investigational Site
Puebla, 72190
MexicoSite Not Available
Consultorio de Endocrinología y Pediatría
Puebla City 3521081, 72190
MexicoSite Not Available
Hospital da Luz
Lisboa, 1500-650
PortugalSite Not Available
Novo Nordisk Investigational Site
Lisboa, 1500-650
PortugalActive - Recruiting
Hospital Da Luz S.A.
Lisbon 2267057, 1500-650
PortugalSite Not Available
CUF-Porto
Porto, 4100-180
PortugalSite Not Available
Centro Hospitalar do Porto, E.P.E
Porto, 4050-342
PortugalActive - Recruiting
Novo Nordisk Investigational Site
Porto, 4100-180
PortugalActive - Recruiting
Unidade Local de Saúde de Santo António, E.P.E
Porto, 4050-342
PortugalSite Not Available
Hospital CUF Porto S.A.
Porto 2735943, 4100-180
PortugalSite Not Available
Unidade Local de Saúde de Santo António, E.P.E
Porto 2735943, 4050-342
PortugalSite Not Available
Drottning Silvias barnsjukhus
Gothenburg 2711537, 41650
SwedenSite Not Available
Drottning Silvias barnsjukhus
Göteborg, 41650
SwedenSite Not Available
Novo Nordisk Investigational Site
Göteborg, 41650
SwedenSite Not Available
Hallands sjukhus Halmstad
Halmstad, 30233
SwedenSite Not Available
Novo Nordisk Investigational Site
Halmstad, 30233
SwedenSite Not Available
Hallands sjukhus Halmstad
Halmstad 2708365, 30233
SwedenSite Not Available
Akademiska sjukhuset Uppsala
Uppsala, 75185
SwedenSite Not Available
Novo Nordisk Investigational Site
Uppsala, 75185
SwedenActive - Recruiting
Akademiska sjukhuset Uppsala
Uppsala 2666199, 75185
SwedenSite Not Available
Uppsala universitetssjukhus
Uppsala 2666199, 75185
SwedenSite Not Available
Birmingham Children's Hospital
Birmingham, B4 6NH
United KingdomSite Not Available
Novo Nordisk Investigational Site
Birmingham, B4 6NH
United KingdomSite Not Available
Birmingham Children's Hospital
Birmingham 2655603, B4 6NH
United KingdomSite Not Available
Novo Nordisk Investigational Site
Bristol, BS2 8BJ
United KingdomSite Not Available
University Hospitals Bristol & Weston NHS Foundation Trust
Bristol, BS2 8BJ
United KingdomSite Not Available
University Hospitals Bristol & Weston NHS Foundation Trust
Bristol 2654675, BS2 8BJ
United KingdomSite Not Available
Novo Nordisk Investigational Site
Great George Street, Leeds, LS1 3EX
United KingdomSite Not Available
Leeds Children's Hospital
Leeds, LS1 3EX
United KingdomSite Not Available
Novo Nordisk Investigational Site
Leeds, LS1 3EX
United KingdomSite Not Available
Leeds Children's Hospital
Leeds 2644688, LS1 3EX
United KingdomSite Not Available
Alder Hey Children's Hospital
Liverpool, L12 2AP
United KingdomSite Not Available
Novo Nordisk Investigational Site
Liverpool, L12 2AP
United KingdomSite Not Available
Alder Hey Children's Hospital
Liverpool 2644210, L12 2AP
United KingdomSite Not Available
Novo Nordisk Investigational Site
Southampton, SO16 6YD
United KingdomSite Not Available
Southampton General Hospital
Southampton, SO16 6YD
United KingdomSite Not Available
Southampton General Hospital
Southampton 2637487, SO16 6YD
United KingdomSite Not Available
Neighborhood Healthcare
Escondido, California 92025
United StatesSite Not Available
Novo Nordisk Investigational Site
Escondido, California 92025
United StatesActive - Recruiting
Neighborhood Healthcare
Escondido 5346827, California 5332921 92025
United StatesSite Not Available
Novo Nordisk Investigational Site
New Haven, Connecticut 06519
United StatesSite Not Available
Yale School of Medicine
New Haven, Connecticut 06519
United StatesSite Not Available
Yale School of Medicine
New Haven 4839366, Connecticut 4831725 06519
United StatesSite Not Available
Columbus Research Foundation
Columbus, Georgia 31904
United StatesSite Not Available
Eastside Bariatric and Gen Surg
Snellville, Georgia 30078
United StatesSite Not Available
Novo Nordisk Investigational Site
Snellville, Georgia 30078
United StatesActive - Recruiting
Columbus Research Foundation
Columbus 4188985, Georgia 4197000 31904
United StatesSite Not Available
Eastside Bariatric and Gen Surg
Snellville 4223413, Georgia 4197000 30078
United StatesSite Not Available
Novo Nordisk Investigational Site
Meridian, Idaho 83646
United StatesActive - Recruiting
Solaris Clinical Research
Meridian, Idaho 83646
United StatesSite Not Available
Solaris Clinical Research
Meridian 5600685, Idaho 5596512 83646
United StatesSite Not Available
Novo Nordisk Investigational Site
Baton Rouge, Louisiana 70808
United StatesActive - Recruiting
Pennington Biom Res Ctr
Baton Rouge, Louisiana 70808
United StatesSite Not Available
Clinical Trials of America LLC
Monroe, Louisiana 71201
United StatesSite Not Available
Novo Nordisk Investigational Site
Monroe, Louisiana 71201
United StatesActive - Recruiting
Pennington Biom Res Ctr
Baton Rouge 4315588, Louisiana 4331987 70808
United StatesSite Not Available
Clinical Trials of America LLC
Monroe 4333669, Louisiana 4331987 71201
United StatesSite Not Available
IMA Clinical Research
Monroe 4333669, Louisiana 4331987 71201
United StatesSite Not Available
Barry J. Reiner, MD LLC
Baltimore, Maryland 21229
United StatesSite Not Available
Novo Nordisk Investigational Site
Baltimore, Maryland 21229
United StatesActive - Recruiting
Barry J. Reiner, MD LLC
Baltimore 4347778, Maryland 4361885 21229
United StatesSite Not Available
Massachusetts General Hospital_Cary
Boston, Massachusetts 02114
United StatesSite Not Available
Novo Nordisk Investigational Site
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital_Cary
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Novo Nordisk Investigational Site
Minneapolis, Minnesota 55414
United StatesActive - Recruiting
University of Minnesota
Minneapolis, Minnesota 55414
United StatesSite Not Available
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55414
United StatesSite Not Available
Mississippi CTR for ADV MED
Madison, Mississippi 39110
United StatesSite Not Available
Mississippi Center for Advanced Medicine
Madison, Mississippi 39110
United StatesSite Not Available
Novo Nordisk Investigational Site
Madison, Mississippi 39110
United StatesSite Not Available
Mississippi CTR for ADV MED
Madison 4434663, Mississippi 4436296 39110
United StatesSite Not Available
Mississippi Center for Advanced Medicine
Madison 4434663, Mississippi 4436296 39110
United StatesSite Not Available
Novo Nordisk Investigational Site
Buffalo, New York 14203
United StatesSite Not Available
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York 14203
United StatesSite Not Available
UBMD Peds-Div of Endo/Diabetes
Buffalo 5110629, New York 5128638 14203
United StatesSite Not Available
Novo Nordisk Investigational Site
Raleigh, North Carolina 27610
United StatesActive - Recruiting
WakeMed Childn Endo-Dbt_Raleig
Raleigh, North Carolina 27610
United StatesSite Not Available
WakeMed Childn Endo-Dbt_Raleig
Raleigh 4487042, North Carolina 4482348 27610
United StatesSite Not Available
Novo Nordisk Investigational Site
Fargo, North Dakota 58104
United StatesActive - Recruiting
Valley Weight Loss Clinic
Fargo, North Dakota 58104
United StatesSite Not Available
Valley Weight Loss Clinic
Fargo 5059163, North Dakota 5690763 58104
United StatesSite Not Available
Centricity Research - Ohio
Columbus, Ohio 43213
United StatesSite Not Available
Novo Nordisk Investigational Site
Columbus, Ohio 43213
United StatesActive - Recruiting
Centricity Research - Ohio
Columbus 4509177, Ohio 5165418 43213
United StatesSite Not Available
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
UPMC Child Hosp-Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15224
United StatesSite Not Available
Novo Nordisk Investigational Site
Nashville, Tennessee 37212
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
Novo Nordisk Investigational Site
Tullahoma, Tennessee 37388
United StatesActive - Recruiting
Tullahoma Pediatrics PLLC
Tullahoma, Tennessee 37388
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37212
United StatesSite Not Available
Tullahoma Pediatrics PLLC
Tullahoma 4663494, Tennessee 4662168 37388
United StatesSite Not Available
Novo Nordisk Investigational Site
Austin, Texas 78731
United StatesActive - Recruiting
Texas Diabetes & Endocrinology
Austin, Texas 78731
United StatesSite Not Available
Novo Nordisk Investigational Site
San Antonio, Texas 78207
United StatesActive - Recruiting
Univ Of Texas Hlth Science Cntr
San Antonio, Texas 78207
United StatesSite Not Available
Texas Diabetes & Endocrinology
Austin 4671654, Texas 4736286 78731
United StatesSite Not Available
Univ Of Texas Hlth Science Cntr
San Antonio 4726206, Texas 4736286 78207
United StatesSite Not Available
Health Res of Hampton Roads
Newport News, Virginia 23606
United StatesSite Not Available
Novo Nordisk Investigational Site
Newport News, Virginia 23606
United StatesActive - Recruiting
Health Res of Hampton Roads
Newport News 4776024, Virginia 6254928 23606
United StatesSite Not Available
Marshfield Clinic
Marshfield, Wisconsin 54449
United StatesSite Not Available
Novo Nordisk Investigational Site
Marshfield, Wisconsin 54449
United StatesSite Not Available
Marshfield Clinic
Marshfield 5261969, Wisconsin 5279468 54449
United StatesSite Not Available

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