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

June 1, 2026 updated by: Novo Nordisk A/S

Weight Maintenance in Adolescents With Obesity; Long-Term Treatment With Semaglutide s.c.2.4 mg Once-weekly

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1090
        • UZ Brussel - Universitair Ziekenhuis Brussel
      • Edegem, Belgium, 2650
        • UZA - Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, 3000
        • UZ Leuven
    • Alberta
      • Calgary, Alberta, Canada, T3B6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • BC Children's Hospital
    • Ontario
      • Markham, Ontario, Canada, L3P 7P3
        • Markham Stouffville Hosp
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
      • West Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill Uni Health Ctre - Glen Site
      • Montreal, Quebec, Canada, H2J 1K1
        • Maison de Sante Prevention
      • Aarhus, Denmark, 8200
        • Aarhus Universitetshospital, Steno Diabetes Center Aarhus
      • Gistrup, Denmark, 9260
        • Aalborg Universitetshospital - Børne og Ungeafdelingen
      • Holbæk, Denmark, 4300
        • Holbæk Sygehus - Børne- og Ungeafdelingen
      • Lille, France, 59037
        • Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre
      • Nice, France, 06200
        • Fondation Lenval Nice
      • Paris, France, 75012
        • Ap-Hp_Hopital Armand Trousseau
      • Rouen, France, 76031
        • Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
      • Toulouse, France, 31059
        • Hopital Des Enfants
      • Bochum, Germany, 44791
        • Kath. Klinikum Bochum gGmbH - Kinderklinik St. Josef-Hospital
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin
      • Göttingen, Germany, 37075
        • Uni-Med. Göttingen - Klinik für Kinder- und Jugendmedizin
      • Hanover, Germany, 30173
        • Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung
      • Hanover, Germany, 30173
        • Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
      • Leipzig, Germany, 04103
        • Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm für Kinder- und Jugendmedizin
      • Ulm, Germany, 89075
        • Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
      • Athens, Greece, 12462
        • U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
      • Goudi/Athens, Greece, 115-27
        • P & A Kyriakou Childrens' Hospital - Department of Endocrinology Growth and Development
      • Pátrai, Greece, 26504
        • General University of Patra - Paediatric Department
      • Thessaloniki, Greece, 546-42
        • 'Ippokrateio' General Hospital of Thessaloniki
      • Thessaloniki, Greece, 54642
        • Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
      • Milan, Italy, 20154
        • Ospedale dei Bambini "Vittore Buzzi"
      • Roma, Italy, 00165
        • Ospedale Pediatrico Bambino Gesù
      • Trieste, Italy, 34137
        • IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
    • Tuscany
      • Florence, Tuscany, Italy, 50139
        • IRCCS Meyer Firenze
      • Puebla City, Mexico, 72190
        • Consultorio de Endocrinología y Pediatría
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • CHRISTUS - Latam Hub Excellence and Innovation Center
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Centro de Estudios de Investigación Metabólicos y Cardio
      • Gdansk, Poland, 80-803
        • COPERNICUS Podmiot Leczniczy Sp. z o.o.
      • Katowice, Poland, 40-752
        • Górnośląskie Centrum Zdrowia Dziecka Im. Św. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 SUM w Katowicach
      • Lodz, Poland, 92-213
        • UMED Clinical Trials sp. z o.o.
      • Rzeszów, Poland, 35-301
        • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
      • Stanisławow Pierwszy Nieporet, Poland, 05-126
        • ELIPSA - Elzbieta Lipska praktyka lekarska Osrodek Endokrynologii i Diabetologii Dzieciecej
      • Warsaw, Poland, 04-730
        • Instytut ''Pomnik - Centrum Zdrowia Dziecka''
      • Zabrze, Poland, 41-800
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-368
        • Klinika Pediatrii, Endokrynologii, Diabetologii I chorób Metabolicznych, Uniwersyteckiego Szpitala Klinicznego in Wrocław
      • Al Ahsa, Saudi Arabia, 36428
        • King Abdulaziz Hospital-Al Ahsa-National Guard
      • Jeddah, Saudi Arabia, 22384
        • National Guard Hospital - Jeddah
      • Riyadh, Saudi Arabia, 12372
        • King Khaled University Hospital,King Saud Univ. Med. City
      • Riyadh, Saudi Arabia, 12713
        • King Faisal Specialist Hospital & Research Centre, Riyadh
      • Riyadh, Saudi Arabia, 14611
        • National Guard Hospital_Riyadh
      • Falun, Sweden, 791 37
        • Falu Lasarett - Barn- och ungdomsmedicinsk mottagning
      • Halmstad, Sweden, 30233
        • Hallands sjukhus Halmstad
      • Malmö, Sweden, 205 02
        • Skåne US Malmö - Barnöverviktsenheten
      • Sundsvall, Sweden, 85643
        • Sundsvalls sjukhus - Barn- och ungdomsmed mott
      • Uppsala, Sweden, 75185
        • Uppsala universitetssjukhus
      • Birmingham, United Kingdom, B4 6NH
        • Birmingham Children's Hospital
      • Bristol, United Kingdom, BS2 8AE
        • University Hospitals Bristol & Weston NHS Foundation Trust
      • Leeds, United Kingdom, LS1 3EX
        • Leeds Children's Hospital
      • Liverpool, United Kingdom, L12 2AP
        • Alder Hey Children's Hospital
      • London, United Kingdom, NW1 1BU
        • University College Hospital - Paediatric Services
      • Sheffield, United Kingdom, S10 2TH
        • Sheffield Children's Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • California
      • Escondido, California, United States, 92025
        • Neighborhood Healthcare
    • Florida
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solution
      • Tallahassee, Florida, United States, 32308
        • TMH Physician Partners Endo
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare Atlanta
      • Columbus, Georgia, United States, 31904
        • Columbus Research Foundation
      • Snellville, Georgia, United States, 30078
        • Eastside Bariatric and Gen Surg
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Synexus Clinical Research US Inc.-Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46505
        • Indiana University Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biom Res Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Barry J. Reiner, MD LLC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota
    • Mississippi
      • Madison, Mississippi, United States, 39110
        • Mississippi CTR for ADV MED
    • New York
      • Buffalo, New York, United States, 14203
        • UBMD Peds-Div of Endo/Diabetes
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Childn Endo-Dbt_Raleig
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Valley Weight Loss Clinic
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Centricity Research - Ohio
      • Dayton, Ohio, United States, 45429
        • Primed Clinical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • UPMC Child Hosp-Pittsburgh
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Ctr
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas Inc
      • San Antonio, Texas, United States, 78207-5209
        • Texas Diabetes Institute
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Res of Hampton Roads
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth Univ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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:

    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:

  • 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:

    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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide
2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly
Participants will receive semaglutide s.c(under the skin) once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of Body Mass Index (BMI) below obesity threshold
Time Frame: From 1.5 years to 3 years
Measures as count of participants
From 1.5 years to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of improved Body Mass Index (BMI) category
Time Frame: From 1.5 years to 3 years and end of continued treatment phase (up to 6 years)
Measured as count of participants
From 1.5 years to 3 years and end of continued treatment phase (up to 6 years)
Tapering to zero dose
Time Frame: From 1.5 years to 3 years
Measured as count of participants
From 1.5 years to 3 years
Time/dose steps before ending dose tapering
Time Frame: From 1.5 years to 3 years
Measured in weeks, count of dose steps
From 1.5 years to 3 years
Achieving Body Mass Index (BMI) below obesity threshold
Time Frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Measured as count of participants
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
Time Frame: From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years)
Measured as count of participants
From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years)
Change in Body Mass Index (BMI)
Time Frame: From baseline (day 0) to 1.5 and 3 years
Measured in percentage (%)
From baseline (day 0) to 1.5 and 3 years
Body Mass Index (BMI) percentage of the 95th percentile
Time Frame: From baseline (day 0) to 1.5 and 3 years
Measured in percentage (%)
From baseline (day 0) to 1.5 and 3 years
Change in Body Mass Index Standard Deviation Score (BMI SDS)
Time Frame: From baseline (day 0) to 1.5 and 3 years
Unitless
From baseline (day 0) to 1.5 and 3 years
Change in waist-to-height ratio (waist [cm]/ height [cm])
Time Frame: From baseline (day 0) to 1.5 and 3 years
Unitless
From baseline (day 0) to 1.5 and 3 years
Change in waist circumference
Time Frame: From baseline (day 0) to 1.5 and 3 years
Measured in centimeters (cm)
From baseline (day 0) to 1.5 and 3 years
Change in HbA1c
Time Frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Measured in percentage (%) points
From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Change in fasting plasma glucose
Time Frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Measured in millimol per liter (mmol/L), milligram per deciliter (mg/dL)
From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Measured in percentage (%)
From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Change in high sensitivity C-reactive protein (hsCRP)
Time Frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Measured in percentage (%)
From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides
Time Frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Measured in percentage (%)
From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Change in systolic and diastolic blood pressure
Time Frame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Measured in millimetres of mercury (mmHg)
From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass
Time Frame: From baseline (day 0) to 1.5 and 3 years
Measured in percentage (%) points
From baseline (day 0) to 1.5 and 3 years
Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass
Time Frame: From baseline (day 0) to 1.5 and 3 years
Measured in percentage (%) points
From baseline (day 0) to 1.5 and 3 years
Serious Adverse Event (SAE)
Time Frame: From baseline (day 0) to 1.5 years, from 1.5 to 3 years, and from 3 years to end of continued treatment phase (up to 6 years)
Count
From baseline (day 0) to 1.5 years, from 1.5 to 3 years, and from 3 years to end of continued treatment phase (up to 6 years)
Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA)
Time Frame: From baseline (day 0) to 1.5 and 3 years
Measured in percentage (%)
From baseline (day 0) to 1.5 and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2024

Primary Completion (Estimated)

November 15, 2028

Study Completion (Estimated)

November 15, 2031

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NN9536-7752
  • U1111-1295-4799 (Other Identifier: World Health Organisation (WHO))
  • 2023-508055-40 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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