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
3 other identifiers
interventional
500
13 countries
93
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Sep 2024
Longer than P75 for phase_4 obesity
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedStudy Start
First participant enrolled
September 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2031
December 18, 2025
December 1, 2025
4.2 years
August 22, 2024
December 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Maintenance of Body Mass Index (BMI) below obesity threshold
Measures as count of participants
From 1.5 years to 3 years
Secondary Outcomes (20)
Maintenance of improved Body Mass Index (BMI) category
From 1.5 years to 3 years and end of continued treatment phase (up to 6 years)
Tapering to zero dose
From 1.5 years to 3 years
Time/dose steps before ending dose tapering
From 1.5 years to 3 years
Achieving Body Mass Index (BMI) below obesity threshold
From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Achieving any improvement in Body Mass Index (BMI) category
From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years)
- +15 more secondary outcomes
Study Arms (1)
Semaglutide
EXPERIMENTAL2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prepubertal status (Tanner stage 1)
- 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
- Endocrine, hypothalamic, or syndromic obesity
- History of type 1 or type 2 diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (93)
Neighborhood Healthcare
Escondido, California, 92025, United States
Clinical Neuroscience Solution
Orlando, Florida, 32801, United States
TMH Physician Partners Endo
Tallahassee, Florida, 32308, United States
Children's Healthcare Atlanta
Atlanta, Georgia, 30329, United States
Columbus Research Foundation
Columbus, Georgia, 31904, United States
Eastside Bariatric and Gen Surg
Snellville, Georgia, 30078, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Synexus Clinical Research US Inc.-Chicago
Chicago, Illinois, 60602, United States
Indiana University Hospital
Indianapolis, Indiana, 46505, United States
University Of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Pennington Biom Res Ctr
Baton Rouge, Louisiana, 70808, United States
Barry J. Reiner, MD LLC
Baltimore, Maryland, 21229, United States
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Mississippi CTR for ADV MED
Madison, Mississippi, 39110, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, 14203, United States
WakeMed Childn Endo-Dbt_Raleig
Raleigh, North Carolina, 27610, United States
Valley Weight Loss Clinic
Fargo, North Dakota, 58104, United States
Centricity Research - Ohio
Columbus, Ohio, 43213, United States
PriMed Clinical Research
Dayton, Ohio, 45429, United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Coastal Carolina Research Ctr
North Charleston, South Carolina, 29405, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119, United States
Texas Diabetes Institute
San Antonio, Texas, 78207-5209, United States
Clinical Trials of Texas Inc
San Antonio, Texas, 78229, United States
Health Res of Hampton Roads
Newport News, Virginia, 23606, United States
Virginia Commonwealth Univ
Richmond, Virginia, 23298, United States
UZ Brussel - Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
UZA - Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Uz Leuven
Leuven, 3000, Belgium
Alberta Children's Hospital
Calgary, Alberta, T3B6A8, Canada
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Markham Stouffville Hosp
Markham, Ontario, L3P 7P3, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
McMaster Children's Hospital
West Hamilton, Ontario, L8N 3Z5, Canada
Maison de Sante Prevention
Montreal, Quebec, H2J 1K1, Canada
McGill Uni Health Ctre - Glen Site
Montreal, Quebec, H4A 3J1, Canada
Aalborg Universitetshospital
Aalborg, 9000, Denmark
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus, 8200, Denmark
Holbæk Sygehus - Børne- og Ungeafdelingen
Holbæk, 4300, Denmark
Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre
Lille, 59037, France
Fondation Lenval Nice
Nice, 06200, France
Ap-Hp_Hopital Armand Trousseau
Paris, 75012, France
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Rouen, 76031, France
Hopital Des Enfants
Toulouse, 31059, France
Kath. Klinikum Bochum gGmbH - Kinderklinik St. Josef-Hospital
Bochum, 44791, Germany
Uni-Med. Göttingen - Klinik für Kinder- und Jugendmedizin
Göttingen, 37075, Germany
Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin
Göttingen, 37075, Germany
Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
Hanover, 30173, Germany
Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung
Hanover, 30173, Germany
Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
Leipzig, 04103, Germany
Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
Leipzig, 04103, Germany
Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
Ulm, 89075, Germany
Universitätsklinikum Ulm für Kinder- und Jugendmedizin
Ulm, 89075, Germany
U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
Athens, 12462, Greece
P & A Kyriakou Childrens' Hospital
Goudi/Athens, 115-27, Greece
General University of Patra - Paediatric Department
Pátrai, 26504, Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, 546-42, Greece
Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
Thessaloniki, 54642, Greece
IRCCS Meyer Firenze
Florence, Tuscany, 50139, Italy
Ospedale dei Bambini "Vittore Buzzi"
Milan, 20154, Italy
Ospedale Pediatrico Bambino Gesu
Roma, 00165, Italy
IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
Trieste, 34137, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
Verona, 37126, Italy
CHRISTUS - Latam Hub Excellence and Innovation Center
Monterrey, Nuevo León, 64060, Mexico
Centro de Estudios de Investigación Metabólicos y Cardio
Ciudad Madero, Tamaulipas, 89440, Mexico
Consultorio de Endocrinología y Pediatría
Puebla City, 72190, Mexico
Klinika Pediatrii, Endokrynologii, Diabetologii I chorób Metabolicznych, Uniwersyteckiego Szpitala Klinicznego in Wrocław
Wroclaw, Lower Silesian Voivodeship, 50-368, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, 80-803, Poland
Górnośląskie Centrum Zdrowia Dziecka Im. Św. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 SUM w Katowicach
Katowice, 40-752, Poland
UMED Clinical Trials sp. z o.o.
Lodz, 92-213, Poland
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, 35-301, Poland
ELIPSA - Elzbieta Lipska praktyka lekarska Osrodek Endokrynologii i Diabetologii Dzieciecej
Stanisławow Pierwszy Nieporet, 05-126, Poland
Instytut ''Pomnik - Centrum Zdrowia Dziecka''
Warsaw, 04-730, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, 41-800, Poland
King Abdulaziz Hospital-Al Ahsa-National Guard
Al Ahsa, 36428, Saudi Arabia
National Guard Hospital - Jeddah
Jeddah, 22384, Saudi Arabia
King Khaled University Hospital,King Saud Univ. Med. City
Riyadh, 12372, Saudi Arabia
King Faisal Specialist Hospital & Research Centre, Riyadh
Riyadh, 12713, Saudi Arabia
National Guard Hospital_Riyadh
Riyadh, 14611, Saudi Arabia
Falu Lasarett - Barn- och ungdomsmedicinsk mottagning
Falun, 791 37, Sweden
Hallands sjukhus Halmstad
Halmstad, 30233, Sweden
Barnöverviktsenheten, SUS Malmö
Malmo, 205 02, Sweden
Sundsvalls sjukhus
Sundsvall, 85643, Sweden
Uppsala universitetssjukhus
Uppsala, 75185, Sweden
Birmingham Children's Hospital
Birmingham, B4 6NH, United Kingdom
University Hospitals Bristol & Weston NHS Foundation Trust
Bristol, BS2 8AE, United Kingdom
Leeds Children's Hospital
Leeds, LS1 3EX, United Kingdom
Alder Hey Children's Hospital
Liverpool, L12 2AP, United Kingdom
University College Hospital Hospital - Paediatric Services
London, NW1 1BU, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2024
First Posted
August 26, 2024
Study Start
September 17, 2024
Primary Completion (Estimated)
November 15, 2028
Study Completion (Estimated)
November 15, 2031
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com