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ObesityPhase 4NCT06571383

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

A Phase 4 study testing Semaglutide in people with Obesity, run by Novo Nordisk A/S at 93 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 15 years
Conditions the study is for
Obesity
What is being tested?
Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
93 sitesin 13 countries
Study dates
17 Sep 2024to 15 Nov 2031
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

93 sites in 13 countries.

93 sites in 13 countries

United States26 sites

  • Children's Healthcare Atlanta

    Atlanta, Georgia, 30329

  • Barry J. Reiner, MD LLC

    Baltimore, Maryland, 21229

  • Pennington Biom Res Ctr

    Baton Rouge, Louisiana, 70808

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York, 14203

  • Synexus Clinical Research US Inc.-Chicago

    Chicago, Illinois, 60602

  • Columbus Research Foundation

    Columbus, Georgia, 31904

  • Centricity Research - Ohio

    Columbus, Ohio, 43213

  • PriMed Clinical Research

    Dayton, Ohio, 45429

  • Neighborhood Healthcare

    Escondido, California, 92025

  • Valley Weight Loss Clinic

    Fargo, North Dakota, 58104

  • Indiana University Hospital

    Indianapolis, Indiana, 46505

  • University Of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Mississippi CTR for ADV MED

    Madison, Mississippi, 39110

  • Clinical Neuroscience Solutions

    Memphis, Tennessee, 38119

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • Health Res of Hampton Roads

    Newport News, Virginia, 23606

  • Coastal Carolina Research Ctr

    North Charleston, South Carolina, 29405

  • Clinical Neuroscience Solution

    Orlando, Florida, 32801

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • WakeMed Childn Endo-Dbt_Raleig

    Raleigh, North Carolina, 27610

  • Virginia Commonwealth Univ

    Richmond, Virginia, 23298

  • Texas Diabetes Institute

    San Antonio, Texas, 78207-5209

  • Clinical Trials of Texas Inc

    San Antonio, Texas, 78229

  • Eastside Bariatric and Gen Surg

    Snellville, Georgia, 30078

  • TMH Physician Partners Endo

    Tallahassee, Florida, 32308

Other trials in United States

Germany9 sites

  • Kath. Klinikum Bochum gGmbH - Kinderklinik St. Josef-Hospital

    Bochum, 44791

  • Uni-Med. Göttingen - Klinik für Kinder- und Jugendmedizin

    Göttingen, 37075

  • Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin

    Göttingen, 37075

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

    Hanover, 30173

  • Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung

    Hanover, 30173

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

    Leipzig, 04103

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

    Leipzig, 04103

  • Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)

    Ulm, 89075

  • Universitätsklinikum Ulm für Kinder- und Jugendmedizin

    Ulm, 89075

Other trials in Germany

Canada8 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T3B6A8

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7

  • Markham Stouffville Hosp

    Markham, Ontario, L3P 7P3

  • Maison de Sante Prevention

    Montreal, Quebec, H2J 1K1

  • McGill Uni Health Ctre - Glen Site

    Montreal, Quebec, H4A 3J1

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • BC Children's Hospital

    Vancouver, British Columbia, V6H 3V4

  • McMaster Children's Hospital

    West Hamilton, Ontario, L8N 3Z5

Other trials in Canada

Poland8 sites

  • Copernicus Podmiot Leczniczy Sp. z o.o.

    Gdansk, 80-803

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

    Katowice, 40-752

  • UMED Clinical Trials sp. z o.o.

    Lodz, 92-213

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

    Rzeszów, 35-301

  • ELIPSA - Elzbieta Lipska praktyka lekarska Osrodek Endokrynologii i Diabetologii Dzieciecej

    Stanisławow Pierwszy Nieporet, 05-126

  • Instytut ''Pomnik - Centrum Zdrowia Dziecka''

    Warsaw, 04-730

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

    Wroclaw, Lower Silesian Voivodeship, 50-368

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

    Zabrze, 41-800

Other trials in Poland

United Kingdom7 sites

  • Birmingham Children's Hospital

    Birmingham, B4 6NH

  • University Hospitals Bristol & Weston NHS Foundation Trust

    Bristol, BS2 8AE

  • Leeds Children's Hospital

    Leeds, LS1 3EX

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP

  • University College Hospital - Paediatric Services

    London, NW1 1BU

  • Sheffield Children's Hospital

    Sheffield, S10 2TH

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

France5 sites

  • Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre

    Lille, 59037

  • Fondation Lenval Nice

    Nice, 06200

  • Ap-Hp_Hopital Armand Trousseau

    Paris, 75012

  • Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

    Rouen, 76031

  • Hopital Des Enfants

    Toulouse, 31059

Other trials in France

Greece5 sites

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

    Athens, 12462

  • P & A Kyriakou Childrens' Hospital - Department of Endocrinology Growth and Development

    Goudi/Athens, 115-27

  • General University of Patra - Paediatric Department

    Pátrai, 26504

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 546-42

  • Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic

    Thessaloniki, 54642

Other trials in Greece

Italy5 sites

  • IRCCS Meyer Firenze

    Florence, Tuscany, 50139

  • Ospedale dei Bambini "Vittore Buzzi"

    Milan, 20154

  • Ospedale Pediatrico Bambino Gesu

    Roma, 00165

  • IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica

    Trieste, 34137

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento

    Verona, 37126

Other trials in Italy

Saudi Arabia5 sites

  • King Abdulaziz Hospital-Al Ahsa-National Guard

    Al Ahsa, 36428

  • National Guard Hospital - Jeddah

    Jeddah, 22384

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

    Riyadh, 12372

  • King Faisal Specialist Hospital & Research Centre, Riyadh

    Riyadh, 12713

  • National Guard Hospital_Riyadh

    Riyadh, 14611

Other trials in Saudi Arabia

Sweden5 sites

  • Falu Lasarett - Barn- och ungdomsmedicinsk mottagning

    Falun, 791 37

  • Hallands sjukhus Halmstad

    Halmstad, 30233

  • Skåne US Malmö - Barnöverviktsenheten

    Malmö, 205 02

  • Sundsvalls sjukhus - Barn- och ungdomsmed mott

    Sundsvall, 85643

  • Uppsala universitetssjukhus

    Uppsala, 75185

Other trials in Sweden

Belgium4 sites

  • UZ Brussel - Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

  • UZA - Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Uz Leuven

    Leuven, 3000

Other trials in Belgium

Denmark3 sites

  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

    Aarhus, 8200

  • Aalborg Universitetshospital - Børne og Ungeafdelingen

    Gistrup, 9260

  • Holbæk Sygehus - Børne- og Ungeafdelingen

    Holbæk, 4300

Other trials in Denmark

Mexico3 sites

  • Centro de Estudios de Investigación Metabólicos y Cardio

    Ciudad Madero, Tamaulipas, 89440

  • CHRISTUS - Latam Hub Excellence and Innovation Center

    Monterrey, Nuevo León, 64060

  • Consultorio de Endocrinología y Pediatría

    Puebla City, 72190

Other trials in Mexico

About this study

Official title: 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.

Conditions
Obesity
Being tested
Semaglutide
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Participants will receive semaglutide s.c(under the skin) once weekly.

Study groups in NCT06571383
Study groupRoleWhat they receive
SemaglutideExperimental2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maintenance of Body Mass Index (BMI) below obesity threshold

    Measures as count of participants

    Measured: From 1.5 years to 3 years

Secondary outcomes (20)

  1. Maintenance of improved Body Mass Index (BMI) category

    Measured as count of participants

    Measured: From 1.5 years to 3 years and end of continued treatment phase (up to 6 years)

  2. Tapering to zero dose

    Measured as count of participants

    Measured: From 1.5 years to 3 years

  3. Time/dose steps before ending dose tapering

    Measured in weeks, count of dose steps

    Measured: From 1.5 years to 3 years

  4. Achieving Body Mass Index (BMI) below obesity threshold

    Measured as count of participants

    Measured: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

  5. Achieving any improvement in Body Mass Index (BMI) category

    Measured as count of participants

    Measured: From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years)

  6. Change in Body Mass Index (BMI)

    Measured in percentage (%)

    Measured: From baseline (day 0) to 1.5 and 3 years

  7. Body Mass Index (BMI) percentage of the 95th percentile

    Measured in percentage (%)

    Measured: From baseline (day 0) to 1.5 and 3 years

  8. Change in Body Mass Index Standard Deviation Score (BMI SDS)

    Unitless

    Measured: From baseline (day 0) to 1.5 and 3 years

  9. Change in waist-to-height ratio (waist [cm]/ height [cm])

    Unitless

    Measured: From baseline (day 0) to 1.5 and 3 years

  10. Change in waist circumference

    Measured in centimeters (cm)

    Measured: From baseline (day 0) to 1.5 and 3 years

  11. Change in HbA1c

    Measured in percentage (%) points

    Measured: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

  12. Change in fasting plasma glucose

    Measured in millimol per liter (mmol/L), milligram per deciliter (mg/dL)

    Measured: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

  13. Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Measured in percentage (%)

    Measured: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

  14. Change in high sensitivity C-reactive protein (hsCRP)

    Measured in percentage (%)

    Measured: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

  15. Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides

    Measured in percentage (%)

    Measured: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

  16. Change in systolic and diastolic blood pressure

    Measured in millimetres of mercury (mmHg)

    Measured: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

  17. Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass

    Measured in percentage (%) points

    Measured: From baseline (day 0) to 1.5 and 3 years

  18. Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass

    Measured in percentage (%) points

    Measured: From baseline (day 0) to 1.5 and 3 years

  19. Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA)

    Measured in percentage (%)

    Measured: From baseline (day 0) to 1.5 and 3 years

  20. Serious Adverse Event (SAE)

    Count

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start17 Sep 2024
  3. Primary completion15 Nov 2028 (estimated)
  4. Study completion15 Nov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571383
Sponsor's protocol ID
NN9536-7752
Other IDs
U1111-1295-4799, 2023-508055-40, 2023
Status last verified
Jun 2026
First submitted
22 Aug 2024
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Semaglutide in people with Obesity, run by Novo Nordisk A/S at 93 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Germany, Canada, Poland, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maintenance of Body Mass Index (BMI) below obesity threshold (time frame: From 1.5 years to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06571383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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Clinical Trial NCT06571383 | AzTrials