STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss
NCT ID: NCT06571383
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
500 participants
INTERVENTIONAL
2024-09-17
2031-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Semaglutide
2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly
Semaglutide
Participants will receive semaglutide s.c(under the skin) once weekly.
Interventions
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Semaglutide
Participants will receive semaglutide s.c(under the skin) once weekly.
Eligibility Criteria
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Inclusion Criteria
1. The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements
2. 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
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:
1. Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening
2. Adjustable gastric banding, if the band has been removed more than 1 year prior to screening
3. Intragastric balloon, if the balloon has been removed more than 1 year prior to screening
4. 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
12 Years
15 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Neighborhood Healthcare
Escondido, California, United States
Clinical Neuroscience Solution
Orlando, Florida, United States
TMH Physician Partners Endo
Tallahassee, Florida, United States
Children's Healthcare Atlanta
Atlanta, Georgia, United States
Columbus Research Foundation
Columbus, Georgia, United States
Eastside Bariatric and Gen Surg
Snellville, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Synexus Clinical Research US Inc.-Chicago
Chicago, Illinois, United States
Indiana University Hospital
Indianapolis, Indiana, United States
University Of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Pennington Biom Res Ctr
Baton Rouge, Louisiana, United States
Barry J. Reiner, MD LLC
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mississippi CTR for ADV MED
Madison, Mississippi, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, United States
WakeMed Childn Endo-Dbt_Raleig
Raleigh, North Carolina, United States
Valley Weight Loss Clinic
Fargo, North Dakota, United States
Centricity Research - Ohio
Columbus, Ohio, United States
PriMed Clinical Research
Dayton, Ohio, United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, United States
Coastal Carolina Research Ctr
North Charleston, South Carolina, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
Texas Diabetes Institute
San Antonio, Texas, United States
Clinical Trials of Texas Inc
San Antonio, Texas, United States
Health Res of Hampton Roads
Newport News, Virginia, United States
Virginia Commonwealth Univ
Richmond, Virginia, United States
UZ Brussel - Universitair Ziekenhuis Brussel
Brussels, , Belgium
Cliniques universitaires Saint-Luc
Brussels, , Belgium
UZA - Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Uz Leuven
Leuven, , Belgium
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Markham Stouffville Hosp
Markham, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
McMaster Children's Hospital
West Hamilton, Ontario, Canada
Maison de Sante Prevention
Montreal, Quebec, Canada
McGill Uni Health Ctre - Glen Site
Montreal, Quebec, Canada
Aalborg Universitetshospital
Aalborg, , Denmark
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus, , Denmark
Holbæk Sygehus - Børne- og Ungeafdelingen
Holbæk, , Denmark
Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre
Lille, , France
Fondation Lenval Nice
Nice, , France
Ap-Hp-Hopital Armand Trousseau
Paris, , France
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Rouen, , France
Hopital Des Enfants-1
Toulouse, , France
Kath. Klinikum Bochum gGmbH - Kinderklinik St. Josef-Hospital
Bochum, , Germany
Uni-Med. Göttingen - Klinik für Kinder- und Jugendmedizin
Göttingen, , Germany
Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin
Göttingen, , Germany
Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
Hanover, , Germany
Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung
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
U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
Athens, , Greece
P & A Kyriakou Childrens' Hospital
Goudi/Athens, , Greece
General University of Patra - Paediatric Department
Pátrai, , Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, , Greece
Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
Thessaloniki, , Greece
IRCCS Meyer Firenze
Florence, Tuscany, Italy
Ospedale dei Bambini "Vittore Buzzi"
Milan, , Italy
Ospedale Pediatrico Bambino Gesu
Roma, , Italy
IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
Trieste, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
Verona, , Italy
CHRISTUS - Latam Hub Excellence and Innovation Center
Monterrey, Nuevo León, Mexico
Centro de Estudios de Investigación Metabólicos y Cardio
Ciudad Madero, Tamaulipas, Mexico
Consultorio de Endocrinología y Pediatría
Puebla City, , Mexico
Klinika Pediatrii, Endokrynologii, Diabetologii I chorób Metabolicznych, Uniwersyteckiego Szpitala Klinicznego in Wrocław
Wroclaw, Lower Silesian Voivodeship, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, , Poland
Górnośląskie Centrum Zdrowia Dziecka Im. Św. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 SUM w Katowicach
Katowice, , Poland
UMED Clinical Trials sp. z o.o.
Lodz, , Poland
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, , Poland
ELIPSA - Elzbieta Lipska praktyka lekarska Osrodek Endokrynologii i Diabetologii Dzieciecej
Stanisławow Pierwszy Nieporet, , Poland
Instytut ''Pomnik - Centrum Zdrowia Dziecka''
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, , Poland
King Abdulaziz Hospital-Al Ahsa-National Guard
Al Ahsa, , Saudi Arabia
National Guard Hospital - Jeddah
Jeddah, , Saudi Arabia
King Khaled University Hospital,King Saud Univ. Med. City
Riyadh, , Saudi Arabia
King Faisal Specialist Hospital & Research Centre, Riyadh
Riyadh, , Saudi Arabia
National Guard Hospital_Riyadh
Riyadh, , Saudi Arabia
Falu Lasarett - Barn- och ungdomsmedicinsk mottagning
Falun, , Sweden
Hallands sjukhus Halmstad
Halmstad, , Sweden
Barnöverviktsenheten, SUS Malmö
Malmo, , Sweden
Sundsvalls sjukhus
Sundsvall, , Sweden
Akademiska sjukhuset Uppsala
Uppsala, , Sweden
Birmingham Children's Hospital
Birmingham, , United Kingdom
University Hospitals Bristol & Weston NHS Foundation Trust
Bristol, , United Kingdom
Leeds Children's Hospital
Leeds, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Paediatric Services - UCL
London, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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U1111-1295-4799
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508055-40
Identifier Type: OTHER
Identifier Source: secondary_id
NN9536-7752
Identifier Type: -
Identifier Source: org_study_id