STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss

Last updated: June 4, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

4

Condition

Obesity

Diabetes Prevention

Treatment

Semaglutide

Clinical Study ID

NCT06571383
NN9536-7752
U1111-1295-4799
2023-508055-40
  • Ages 12-15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study:
  1. The parent(s) or legally acceptable representative (LAR) of the participantmust sign and date the Informed Consent Form, according to local requirements

  2. The participant must sign and date the Child Assent Form or provide oralassent, 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

Exclusion criteria:

  • Prepubertal status (Tanner stage 1)

  • Treatment with any medication prescribed for the indication of obesity or weightmanagement within 90 days before screening

  • Previous or planned (during the study period) obesity treatment with surgery or aweight loss device. However, the following are allowed:

  1. Liposuction and/or abdominoplasty, if performed more than 1 year prior toscreening

  2. Adjustable gastric banding, if the band has been removed more than 1 year priorto screening

  3. Intragastric balloon, if the balloon has been removed more than 1 year prior toscreening

  4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has beenremoved more than 1 year prior to screening

  • Endocrine, hypothalamic, or syndromic obesity

  • History of type 1 or type 2 diabetes mellitus

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Semaglutide
Phase: 4
Study Start date:
September 17, 2024
Estimated Completion Date:
November 15, 2031

Connect with a study center

  • UZ Brussel - Universitair Ziekenhuis Brussel

    Brussel, 1090
    Belgium

    Active - Recruiting

  • Cliniques universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • UZA - Universitair Ziekenhuis Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Uz Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Alberta Children's Hospital

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Walter C. Mackenzie Hlth Sci Ctr

    Edmonton, Alberta T6G 2E1
    Canada

    Site Not Available

  • BC Children's Hospital

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • Hamilton Health Sciences Corp, Ontario

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Markham Stouffville Hosp

    Markham, Ontario L6B0T1
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • McMaster Children's Hospital

    West Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Maison de Sante Prevention

    Montreal, Quebec H2J 1K1
    Canada

    Site Not Available

  • McGill Uni Health Ctre - Glen Site

    Montreal, Quebec H4V 1J3
    Canada

    Site Not Available

  • Aalborg Universitetshospital

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

    Aarhus, 8200
    Denmark

    Site Not Available

  • Holbæk Sygehus

    Holbæk, 4300
    Denmark

    Active - Recruiting

  • Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre

    Lille Cedex, 59037
    France

    Site Not Available

  • Fondation Lenval Nice

    Nice, 06200
    France

    Active - Recruiting

  • Ap-Hp-Hopital Armand Trousseau

    Paris, 75012
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

    Rouen cedex, 76031
    France

    Active - Recruiting

  • Hopital Des Enfants-1

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Kinderkrankenhaus Bochum

    Bochum, 44791
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin

    Göttingen, 37075
    Germany

    Site Not Available

  • Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung

    Hannover, 30173
    Germany

    Site Not Available

  • Kinder- und Jugendkrankenhaus Auf der Bult

    Hannover, 30173
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin

    Leipzig, 04103
    Germany

    Site Not Available

  • Deutsches Zentrum für Kinder- und Jugendgesundheit (DZKJ)

    Ulm, 89075
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm für Kinder- und Jugendmedizin

    Ulm, 89075
    Germany

    Site Not Available

  • U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic

    Athens, 12462
    Greece

    Active - Recruiting

  • P & A Kyriakou Childrens' Hospital

    Goudi/Athens, 115-27
    Greece

    Active - Recruiting

  • U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic

    Haidari-Athens, GR-12462
    Greece

    Site Not Available

  • General University of Patra - Paediatric Department

    Patra, 26504
    Greece

    Active - Recruiting

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 546-42
    Greece

    Active - Recruiting

  • Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic

    Thessaloniki, 54642
    Greece

    Active - Recruiting

  • IRCCS Meyer Firenze

    Florence, Toscana 50139
    Italy

    Active - Recruiting

  • Ospedale dei Bambini "Vittore Buzzi"

    Milan, 20154
    Italy

    Active - Recruiting

  • Bambin Gesù

    Roma, 00165
    Italy

    Site Not Available

  • IRCCS materno infantile Burlo Garofolo

    Trieste, 34137
    Italy

    Active - Recruiting

  • AOU Integrata di Verona - Ospedale Civile Maggiore

    Verona, 37126
    Italy

    Active - Recruiting

  • CHRISTUS - Latam Hub Excellence and Innovation Center

    Monterrey, Nuevo León 64060
    Mexico

    Site Not Available

  • Centro de Estudios de Investigación Metabólicos y Cardio

    Ciudad Madero, Tamaulipas 89440
    Mexico

    Site Not Available

  • Consultorio de Endocrinología y Pediatría

    Puebla, 72190
    Mexico

    Site Not Available

  • Klinika Pediatrii, Endokrynologii, Diabetologii I chorób Metabolicznych, Uniwersyteckiego Szpitala Klinicznego in Wrocław

    Wrocław, Dolnośląskie 50-368
    Poland

    Active - Recruiting

  • Copernicus Podmiot Leczniczy Sp. z o.o.

    Gdańsk, 80-803
    Poland

    Site Not Available

  • Górnośląskie Centrum Zdrowia Dziecka Im. Św. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 SUM w Katowicach

    Katowice, 40-752
    Poland

    Site Not Available

  • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie

    Rzeszów, 35-301
    Poland

    Active - Recruiting

  • ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej

    Stanisławów Pierwszy Nieporęt, 05-126
    Poland

    Active - Recruiting

  • Elipsa Ośrodek Endokrynologiczny

    Stanisławów Pierwszy Nieporęt, 05-126
    Poland

    Site Not Available

  • Instytut ''Pomnik - Centrum Zdrowia Dziecka''

    Warszawa, 04-730
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

    Zabrze, 41-800
    Poland

    Active - Recruiting

  • UMED Clinical Trials sp. z o.o.

    Łódź, 92-213
    Poland

    Active - Recruiting

  • King Abdulaziz Hospital-Al Ahsa-National Guard

    Al Ahsa, 36428
    Saudi Arabia

    Site Not Available

  • National Guard Hospital - Jeddah

    Jeddah, 22384
    Saudi Arabia

    Site Not Available

  • King Faisal Specialist Hospital & Research Centre, Riyadh

    Riyadh, 12713
    Saudi Arabia

    Site Not Available

  • King Khaled University Hospital,King Saud Univ. Med. City

    Riyadh, 12372
    Saudi Arabia

    Active - Recruiting

  • National Guard Hospital_Riyadh

    Riyadh, 14611
    Saudi Arabia

    Site Not Available

  • Barn- och ungdomsmedicinsk mottagning Falun lasarett

    Falun, 791 37
    Sweden

    Site Not Available

  • Hallands sjukhus Halmstad

    Halmstad, 30233
    Sweden

    Active - Recruiting

  • Barnöverviktsenheten, SUS Malmö

    Malmö, 205 02
    Sweden

    Site Not Available

  • Sundsvalls sjukhus

    Sundsvall, 85643
    Sweden

    Active - Recruiting

  • Akademiska sjukhuset Uppsala

    Uppsala, 75185
    Sweden

    Active - Recruiting

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • University Hospitals Bristol & Weston NHS Foundation Trust

    Bristol, BS2 8AE
    United Kingdom

    Active - Recruiting

  • Leeds Children's Hospital

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP
    United Kingdom

    Active - Recruiting

  • Paediatric Services - UCL

    London, NW1 1BU
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Neighborhood Healthcare

    Escondido, California 92025
    United States

    Site Not Available

  • Clinical Neuroscience Solution

    Orlando, Florida 32801
    United States

    Site Not Available

  • TMH Physician Partners Endo

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Children's Healthcare Atlanta

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Columbus Research Foundation

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Eastside Bariatric and Gen Surg

    Snellville, Georgia 30078
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Active - Recruiting

  • Synexus Clinical Research US Inc.-Chicago

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Indiana University Hospital

    Indianapolis, Indiana 46505
    United States

    Site Not Available

  • Indiana University of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University Of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Pennington Biom Res Ctr

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • Barry J. Reiner, MD LLC

    Baltimore, Maryland 21229
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Active - Recruiting

  • Mississippi CTR for ADV MED

    Madison, Mississippi 39110
    United States

    Site Not Available

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York 14203
    United States

    Site Not Available

  • WakeMed Childn Endo-Dbt_Raleig

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Valley Weight Loss Clinic

    Fargo, North Dakota 58104
    United States

    Active - Recruiting

  • Centricity Research - Ohio

    Columbus, Ohio 43213
    United States

    Active - Recruiting

  • PriMed Clinical Research

    Dayton, Ohio 45429
    United States

    Active - Recruiting

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Coastal Carolina Research Ctr

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Clinical Neuroscience Solutions

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Clinical Trials of Texas Inc

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Diabetes Institute

    San Antonio, Texas 78207-5209
    United States

    Active - Recruiting

  • Health Res of Hampton Roads

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • Virginia Commonwealth Univ

    Richmond, Virginia 23298
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.