Phase
Condition
Obesity
Diabetes Prevention
Treatment
Semaglutide
Placebo
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
Novo Nordisk Investigational Site
Salzburg, 5020
AustriaSite Not Available
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg, 5020
AustriaSite Not Available
Novo Nordisk Investigational Site
Brussel, 1090
BelgiumActive - Recruiting
UZ Brussel
Brussel, 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
Novo Nordisk Investigational Site
Leuven, 3000
BelgiumActive - Recruiting
UZ Leuven - Kindergeneeskunde
Leuven, 3000
BelgiumSite Not Available
Aalborg Universitetshospital
Aalborg, 9000
DenmarkSite Not Available
Novo Nordisk Investigational Site
Aalborg, 9000
DenmarkSite Not Available
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus, 8200
DenmarkSite Not Available
Novo Nordisk Investigational Site
Aarhus, 8200
DenmarkActive - Recruiting
Holbæk Sygehus
Holbæk, 4300
DenmarkSite Not Available
Novo Nordisk Investigational Site
Holbæk, 4300
DenmarkSite Not Available
Novo Nordisk Investigational Site
Halle, 06120
GermanySite Not Available
Universitätsklinikum Halle (Saale)
Halle, 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
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
Novo Nordisk Investigational Site
Ulm, 89075
GermanySite Not Available
Universitätsklinikum Ulm für Kinder- und Jugendmedizin
Ulm, 89075
GermanySite Not Available
Novo Nordisk Investigational Site
Haifa, 31096
IsraelActive - Recruiting
Rambam Medical Center Children A Dept.
Haifa, 31096
IsraelSite Not Available
Endrocrinology & DM Schneider MC
Petah Tikva, 49202
IsraelSite Not Available
Novo Nordisk Investigational Site
Petah Tikva, 49202
IsraelActive - Recruiting
Novo Nordisk Investigational Site
Zerifin, 70300
IsraelActive - Recruiting
Shamir (Assaf Harofe) Medical Center
Zerifin, 7033001
IsraelSite Not Available
Consultorio de Endocrinología y Pediatría
Puebla, 72190
MexicoSite Not Available
Novo Nordisk Investigational Site
Puebla, 72190
MexicoSite Not Available
Hospital da Luz
Lisboa, 1500-650
PortugalSite Not Available
Novo Nordisk Investigational Site
Lisboa, 1500-650
PortugalActive - Recruiting
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, 4050-342
PortugalActive - Recruiting
Unidade Local de Saúde de Santo António, E.P.E
Porto, 4050-342
PortugalSite 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
Akademiska sjukhuset Uppsala
Uppsala, 75185
SwedenSite Not Available
Novo Nordisk Investigational Site
Uppsala, 75185
SwedenActive - Recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
United KingdomSite Not Available
Novo Nordisk Investigational Site
Birmingham, 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
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
Alder Hey Children's Hospital
Liverpool, L12 2AP
United KingdomSite Not Available
Novo Nordisk Investigational Site
Liverpool, 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
Neighborhood Healthcare
Escondido, California 92025
United StatesSite Not Available
Novo Nordisk Investigational Site
Escondido, California 92025
United StatesActive - Recruiting
Novo Nordisk Investigational Site
New Haven, Connecticut 06519
United StatesSite Not Available
Yale School of Medicine
New Haven, Connecticut 06519
United StatesSite Not Available
Columbus Research Foundation
Columbus, Georgia 31904
United StatesSite Not Available
Novo Nordisk Investigational Site
Columbus, Georgia 31904
United StatesActive - Recruiting
Eastside Bariatric and Gen Surg
Snellville, Georgia 30078
United StatesSite Not Available
Novo Nordisk Investigational Site
Snellville, Georgia 30078
United StatesActive - Recruiting
Novo Nordisk Investigational Site
Meridian, Idaho 83646
United StatesActive - Recruiting
Solaris Clinical Research
Meridian, Idaho 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
Barry J. Reiner, MD LLC
Baltimore, Maryland 21229
United StatesSite Not Available
Novo Nordisk Investigational Site
Baltimore, Maryland 21229
United StatesActive - Recruiting
Massachusetts General Hospital_Cary
Boston, Massachusetts 02114
United StatesSite Not Available
Novo Nordisk Investigational Site
Boston, Massachusetts 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
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
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
Novo Nordisk Investigational Site
Raleigh, North Carolina 27610
United StatesActive - Recruiting
WakeMed Childn Endo-Dbt_Raleig
Raleigh, North Carolina 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
Centricity Research - Ohio
Columbus, Ohio 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
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
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
Health Res of Hampton Roads
Newport News, Virginia 23606
United StatesSite Not Available
Novo Nordisk Investigational Site
Newport News, Virginia 23606
United StatesActive - Recruiting
Marshfield Clinic
Marshfield, Wisconsin 54449
United StatesSite Not Available
Novo Nordisk Investigational Site
Marshfield, Wisconsin 54449
United StatesSite Not Available
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