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Active (not recruiting) Phase 3 NCT05726227

A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight

Phase 3 – large-scale trial before approval
Conditions: Obesity

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
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).
Who can participate
Inclusion Criteria: * Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. a) The parents or LAR of the child must sign and date the Informed Consent Form (according to local requirements) b) The child must sign and date the Child Assent Form or provide 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) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence 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 after participation in a structured lifestyle modification programme (diet and exercise counselling) 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 per mole \[mmol/mol\]) as measured by central laboratory at screening Exclusion Criteria: * Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve 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 criterion applies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Interventions
Semaglutide
DRUG
Placebo
DRUG
Locations 56
Austria (2)
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
Innsbruck
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg
Belgium (4)
UZ Brussel
Brussels
UZ Antwerpen - UZA - Kinderziekenhuis
Edegem
UZA - UZ Antwerpen - Kinderziekenhuis
Edegem
UZ Leuven - Kindergeneeskunde
Leuven
Denmark (3)
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus
Aalborg Universitetshospital - Børne og Ungeafdelingen
Gistrup
Holbæk Sygehus - Børne- og Ungeafdelingen
Holbæk
Germany (7)
Universitätsklinikum Halle - Innere Medizin II
Halle
Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung
Hanover
Kinder- und Jugendkrankenhaus
Hanover
Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
Leipzig
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin
Leipzig
Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
Ulm
Universitätsklinikum Ulm für Kinder- und Jugendmedizin
Ulm
Israel (3)
Rambam MC - Department of Pediatrics A
Haifa
Schneider MC - Endrocrinology and Diabetes
Petah Tikva
Shamir MC - Pediatric and Adolescents Endocrinology unit
Ẕerifin
Mexico (1)
Consultorio de Endocrinología y Pediatría
Puebla City
Portugal (3)
Hospital da Luz Lisboa, S.A.
Lisbon
ULS De Santo António, E.P.E. - Hospital de Santo António
Porto
Hospital CUF Porto S.A.
Porto
Sweden (4)
Drottning Silvias barnsjukhus
Gothenburg
Hallands sjukhus Halmstad
Halmstad
Akademiska sjukhuset Uppsala
Uppsala
Uppsala universitetssjukhus
Uppsala
United Kingdom (5)
Birmingham Children's Hospital
Birmingham
University Hospitals Bristol & Weston NHS Foundation Trust
Bristol
Leeds Children's Hospital
Leeds
Alder Hey Children's Hospital
Liverpool
Southampton General Hospital
Southampton
United States (24)
Texas Diabetes & Endocrinology
Austin , Texas
Barry J. Reiner, MD LLC
Baltimore , Maryland
Pennington Biom Res Ctr
Baton Rouge , Louisiana
Massachusetts General Hospital_Cary
Boston , Massachusetts
UBMD Peds-Div of Endo/Diabetes
Buffalo , New York
Columbus Research Foundation
Columbus , Georgia
Centricity Research - Ohio
Columbus , Ohio
Neighborhood Healthcare
Escondido , California
Valley Weight Loss Clinic
Fargo , North Dakota
Mississippi Center for Advanced Medicine
Madison , Mississippi
Mississippi CTR for ADV MED
Madison , Mississippi
Marshfield Clinic
Marshfield , Wisconsin
Solaris Clinical Research
Meridian , Idaho
University of Minnesota
Minneapolis , Minnesota
Clinical Trials of America LLC
Monroe , Louisiana
IMA Clinical Research
Monroe , Louisiana
Vanderbilt University Medical Center
Nashville , Tennessee
Yale School of Medicine
New Haven , Connecticut
Health Res of Hampton Roads
Newport News , Virginia
UPMC Child Hosp-Pittsburgh
Pittsburgh , Pennsylvania
WakeMed Childn Endo-Dbt_Raleig
Raleigh , North Carolina
Univ Of Texas Hlth Science Cntr
San Antonio , Texas
Eastside Bariatric and Gen Surg
Snellville , Georgia
Pediatric Clinical Trials, LLC
Tullahoma , Tennessee
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
07.07.2023
Completion date
07.12.2026
Registry ID
NCT05726227
Source
clinicaltrials.gov
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