Phase
Condition
Obesity
Diabetes Prevention
Hypertriglyceridemia
Treatment
Semaglutide
Placebo
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent of parent(s) or legally acceptable representative of subject andchild assent, as appropriate obtained before any trial-related activities.Trial-related activities are any procedures that are carried out as part of thetrial, including activities to determine suitability for the trial
Male or female, ages 12 to below 18 years at the time of signing informed consent
BMI equal to or above 95th percentile OR equal to or above 85th percentile (ongender and age-specific growth charts (CDC.gov)) with 1 or more weight relatedcomorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleepapnoea or type 2 diabetes
History of at least one self-reported unsuccessful dietary effort to lose weight
For subjects with type 2 diabetes at screening the following inclusion criteria apply in addition:
- HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening
Exclusion
Exclusion Criteria:
Prepubertal subjects (Tanner stage 1)
History of type 1 diabetes
A self-reported (or by parent(s)/legally acceptable representative where applicable)change in body weight above 5 kg (11 lbs) within 90 days before screeningirrespective of medical records
Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic orendocrine causes)
For subjects with type 2 diabetes only: Uncontrolled and potentially unstablediabetic retinopathy or maculopathy. Verified by a fundus examination performedwithin the past 90 days prior to screening. Pharmacological pupil-dilation is arequirement unless using a digital fundus photography camera specified fornon-dilated examination
Study Design
Connect with a study center
Fließer-Görzer [Ordination]
Saint Stefan, 8511
AustriaSite Not Available
Novo Nordisk Investigational Site
Saint Stefan, 8511
AustriaSite Not Available
Novo Nordisk Investigational Site
Salzburg, 5020
AustriaSite Not Available
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg 2766824, 5020
AustriaSite Not Available
Ordination Dr. Hanusch
Vienna 2761369, 1060
AustriaSite Not Available
Novo Nordisk Investigational Site
Wien, 1060
AustriaSite Not Available
Novo Nordisk Investigational Site
Brussel, 1090
BelgiumSite Not Available
Novo Nordisk Investigational Site
Brussels, 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
Brussels 2800866, 1200
BelgiumSite Not Available
UZ Brussel
Brussels 2800866, 1090
BelgiumSite Not Available
Novo Nordisk Investigational Site
Bruxelles, 1200
BelgiumSite Not Available
Novo Nordisk Investigational Site
Edegem, 2650
BelgiumSite Not Available
UZA - UZ Antwerpen - Kinderziekenhuis
Edegem 2799007, 2650
BelgiumSite Not Available
Novo Nordisk Investigational Site
Leuven, 3000
BelgiumSite Not Available
UZ Leuven - Kindergeneeskunde
Leuven 2792482, 3000
BelgiumSite Not Available
Novo Nordisk Investigational Site
Rijeka, 51000
CroatiaSite Not Available
Klinički bolnički centar Rijeka, pedijatrija
Rijeka 3191648, 51000
CroatiaSite Not Available
Novo Nordisk Investigational Site
Zagreb, 10 000
CroatiaSite Not Available
KBC "Sestre Milosrdnice"
Zagreb 3186886, 10 000
CroatiaSite Not Available
KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes
Zagreb 3186886, 10000
CroatiaSite Not Available
Novo Nordisk Investigational Site
Dublin, Leinster D04 T6F4
IrelandSite Not Available
Clinical Research Centre, St. Vincent's University Hospital,
Dublin 2964574, Leinster 7521314 D04 T6F4
IrelandSite Not Available
Novo Nordisk Investigational Site
Puebla, 72190
MexicoSite Not Available
Consultorio de Endocrinología y Pediatría
Puebla City 3521081, 72190
MexicoSite Not Available
Republic Children's Hospital of Ministry of Health of Udmurt
Izhevsk 554840, 426009
RussiaSite Not Available
RMAPE
Moscow 524901, 125373
RussiaSite Not Available
NSMU paediatric clinic
Novosibirsk 1496747, 630048
RussiaSite Not Available
FSBEI of Higher Education "Rostov State Medical University"
Rostov-on-Don 501175, 344013
RussiaSite Not Available
City Children Endocrinology Center n.a. Raukhfus
Saint Petersburg 498817, 191036
RussiaSite Not Available
SPSBHI City Children out-patient clinic #44
Saint Petersburg 498817, 191144
RussiaSite Not Available
Siberian State Medical University
Tomsk 1489425, 634050
RussiaSite Not Available
Novo Nordisk Investigational Site
Izhevsk, 426009
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Moscow, 125373
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Novosibirsk, 630048
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Rostov-on-Don, 344013
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Saint-Petersburg, 191036
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Tomsk, 634050
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Rotherham, South Yorkshire S65 1DA
United KingdomSite Not Available
Clifton Medical Centre
Rotherham 2639093, South Yorkshire S65 1DA
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 8AE
United KingdomSite Not Available
University Hospitals Bristol & Weston NHS Foundation Trust
Bristol 2654675, BS2 8AE
United KingdomSite Not Available
Novo Nordisk Investigational Site
London, WC1E 6DB
United KingdomSite Not Available
Paediatric Services - UCL
London 2643743, WC1E 6DB
United KingdomSite Not Available
Novo Nordisk Investigational Site
Sheffield, S35 9XQ
United KingdomSite Not Available
Ecclesfield Group Practice
Sheffield 2638077, S35 9XQ
United KingdomSite Not Available
Novo Nordisk Investigational Site
Southampton, SO16 6YD
United KingdomSite Not Available
Southampton General Hospital
Southampton 2637487, SO16 6YD
United KingdomSite Not Available
Novo Nordisk Investigational Site
Meridian, Idaho 83646
United StatesSite Not Available
Solaris Clinical Research
Meridian 5600685, Idaho 5596512 83646
United StatesSite Not Available
Novo Nordisk Investigational Site
Baltimore, Maryland 21229
United StatesSite Not Available
Barry J. Reiner, MD LLC
Baltimore 4347778, Maryland 4361885 21229
United StatesSite Not Available
Novo Nordisk Investigational Site
Boston, Massachusetts 02114-2621
United StatesSite Not Available
Massachusetts General Hospital_Cary
Boston 4930956, Massachusetts 6254926 02114-2621
United StatesSite Not Available
Novo Nordisk Investigational Site
Minneapolis, Minnesota 55414
United StatesSite Not Available
University of Minnesota_CPOM
Minneapolis 5037649, Minnesota 5037779 55414
United StatesSite Not Available
Novo Nordisk Investigational Site
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 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 StatesSite Not Available
Valley Weight Loss Clinic
Fargo 5059163, North Dakota 5690763 58104
United StatesSite Not Available
Novo Nordisk Investigational Site
Columbus, Ohio 43213
United StatesSite Not Available
Novo Nordisk Investigational Site
Dayton, Ohio 45419
United StatesSite Not Available
Aventiv Research Inc
Columbus 4509177, Ohio 5165418 43213
United StatesSite Not Available
PriMed Clinical Research
Dayton 4509884, Ohio 5165418 45419
United StatesSite Not Available
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
UPMC Child Hosp-Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15224
United StatesSite Not Available
Novo Nordisk Investigational Site
Goose Creek, South Carolina 29445
United StatesSite Not Available
Novo Nordisk Investigational Site
Rapid City, South Dakota 57701
United StatesSite Not Available
Monument Health Clinical Rsrch
Rapid City 5768233, South Dakota 5769223 57701
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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