NCT06571383Active, not recruitingPhase 4
STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss
Weight Maintenance in Adolescents With Obesity; Long-Term Treatment With Semaglutide s.c.2.4 mg Once-weekly
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
The study is testing how well semaglutide can help adolescents with excess body weight to lose weight and to maintain weight loss. All participants in the study will receive semaglutide as a weekly injection. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. All participants will get semaglutide treatment for a minimum of 3 years.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 22 Aug 2024
- Start date
- 17 Sept 2024
- Primary completion date
- 15 Nov 2028
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT06571383
- EU CT number
- 2023-508055-40-00
- EudraCT number
- 2023-508055-40
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 500
- From 17 Sept 2024 to the primary completion date, 15 Nov 2028
- 84 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening
- Adjustable gastric banding, if the band has been removed more than 1 year prior to screening
- Intragastric balloon, if the balloon has been removed more than 1 year prior to screening
- Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed more than 1 year prior to screening
Other illness
- History of type 1 or type 2 diabetes mellitus
Other
- Prepubertal status (Tanner stage 1)
- Endocrine, hypothalamic, or syndromic obesity
Who the study is looking for
- Informed consent 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:
- The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements
- The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements
- Age 12 to less than 15 years at the time of signing the informed consent
- BMI greater than or equal to 95th percentile at screening
- Body weight greater than 60 kg at screening
Age in the registry: 12 years to 15 years · Sex: All · Does not accept healthy volunteers
Sites (84)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Active, not recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Alberta Children's Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Stollery Children'S Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Markham Stouffville Hosp Coordinator of this site? Confirm its status | Markham | Canada | Unknown status |
| Maison de Sante Prevention Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill Uni Health Ctre - Glen Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BC Children ' s Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| McMaster Children's Hospital Coordinator of this site? Confirm its status | West Hamilton | Canada | Unknown status |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Active, not recruiting |
| Hannoversche Kinderheilanstalt Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Universitaetsklinikum Leipzig Aor Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Active, not recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Holbaek Sygehus Coordinator of this site? Confirm its status | Holbæk | Denmark | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Fondation Lenval Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Hopital Des Enfants Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| University Hospitals Bristol & Weston NHS Foundation Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Leeds Children's hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Alder Hey Children's Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| University College Hospital - Paediatric Services Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Sheffield Children's Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Athens General Children's Hospital Panagioti And Aglaia Kyriakou Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Active, not recruiting |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Coordinator of this site? Confirm its status | Trieste | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Active, not recruiting |
| Centro de Estudios de Investigación Metabólicos y Cardio Coordinator of this site? Confirm its status | Ciudad Madero | Mexico | Unknown status |
| CHRISTUS - Latam Hub Excellence and Innovation Center Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Consultorio de Endocrinología y Pediatría Coordinator of this site? Confirm its status | Puebla City | Mexico | Unknown status |
| Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Umed Clinical Trials Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Active, not recruiting |
| ELIPSA - Elzbieta Lipska praktyka lekarska Osrodek Endokrynologii i Diabetologii Dzieciecej Coordinator of this site? Confirm its status | Stanisławow Pierwszy Nieporet | Poland | Active, not recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Zabrze | Poland | Active, not recruiting |
| King Abdulaziz Hospital-Al Ahsa-National Guard Coordinator of this site? Confirm its status | Al Ahsa | Saudi Arabia | Unknown status |
| National Guard Hospital - Jeddah Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
| National Guard Hospital, Riyadh Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| King Khaled University Hospital,King Saud Univ. Med. City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| King Faisal Specialist Hospital & Research Centre Riyadh Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Region Dalarna Coordinator of this site? Confirm its status | Falun | Sweden | Active, not recruiting |
| Region Halland Coordinator of this site? Confirm its status | Halmstad | Sweden | Active, not recruiting |
| Region Vaesternorrland Coordinator of this site? Confirm its status | Sundsvall | Sweden | Active, not recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
| Children's Healthcare Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Barry J. Reiner, MD, LLC Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Pennington Biom Res Ctr Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| UBMD Peds-Div of Endo/Diabetes Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Synexus Clinical Research US Inc.-Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Centricity Research - Ohio Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Columbus Research Foundation Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Primed Clinical Research Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Neighborhood Healthcare Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| Valley Weight Loss Clinic Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Indiana University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Mississippi CTR for ADV MED Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Clinical Neuroscience Solutions Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Solaris Clinical Research Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Health Res of Hampton Roads Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Coastal Carolina Research Ctr Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Clinical Neuroscience Solution Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| UPMC Child Hosp-Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| WakeMed Childn Endo-Dbt_Raleig Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Virginia Commonwealth Univ Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Texas Diabetes Institute Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Clinical Trials of Texas Inc Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Eastside Bariatric and Gen Surg Coordinator of this site? Confirm its status | Snellville | United States | Unknown status |
| TMH Physician Partners Endo Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.