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Clinical Trials in the UK / NCT05726227
Active, not recruiting Phase 3

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

NCT05726227 · tracked via the Priya Life Science UK tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2023-07-07
Last updated
2026-09-09

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

SemaglutidePlacebo

Semaglutide: Semaglutide will be administered subcutaneously once weekly.

Placebo: Placebo will be administered subcutaneously once-weekly.

Study summary

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).

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Neighborhood Healthcare Escondido California
Yale School of Medicine New Haven Connecticut
Columbus Research Foundation Columbus Georgia
Eastside Bariatric and Gen Surg Snellville Georgia
Solaris Clinical Research Meridian Idaho
Pennington Biom Res Ctr Baton Rouge Louisiana
Clinical Trials of America LLC Monroe Louisiana
IMA Clinical Research Monroe Louisiana
Barry J. Reiner, MD LLC Baltimore Maryland
Massachusetts General Hospital_Cary Boston Massachusetts
University of Minnesota Minneapolis Minnesota
Mississippi Center for Advanced Medicine Madison Mississippi
Mississippi CTR for ADV MED Madison Mississippi
UBMD Peds-Div of Endo/Diabetes Buffalo New York
WakeMed Childn Endo-Dbt_Raleig Raleigh North Carolina
Valley Weight Loss Clinic Fargo North Dakota
Centricity Research - Ohio Columbus Ohio
UPMC Child Hosp-Pittsburgh Pittsburgh Pennsylvania
Vanderbilt University Medical Center Nashville Tennessee
Pediatric Clinical Trials, LLC Tullahoma Tennessee
Texas Diabetes & Endocrinology Austin Texas
Univ Of Texas Hlth Science Cntr San Antonio Texas
Health Res of Hampton Roads Newport News Virginia
Marshfield Clinic Marshfield Wisconsin
Universitätsklinik Kinder-Jugendheilkunde Innsbruck Innsbruck Austria
Universitätsklinik für Kinder und Jugendheilkunde Haus E Salzburg Austria
UZ Brussel Brussels Belgium
UZ Antwerpen - UZA - Kinderziekenhuis Edegem Belgium
UZA - UZ Antwerpen - Kinderziekenhuis Edegem Belgium
UZ Leuven - Kindergeneeskunde Leuven Belgium
Aarhus Universitetshospital, Steno Diabetes Center Aarhus Aarhus Denmark
Aalborg Universitetshospital - Børne og Ungeafdelingen Gistrup Denmark
Holbæk Sygehus - Børne- og Ungeafdelingen Holbæk Denmark
Universitätsklinikum Halle - Innere Medizin II Halle Germany
Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung Hanover Germany
Kinder- und Jugendkrankenhaus Hanover Germany
Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin Leipzig Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin Leipzig Germany
Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ) Ulm Germany
Universitätsklinikum Ulm für Kinder- und Jugendmedizin Ulm Germany

+ 16 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

More Novo Nordisk A/S trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05726227 on ClinicalTrials.gov ↗ ← All trials in the UK