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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Contact
Study Contact
- Name: Novo Nordisk
- Phone Number: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Study Locations
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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Brussels, Belgium, 1090
- UZ Brussel - Universitair Ziekenhuis Brussel
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Edegem, Belgium, 2650
- UZA - Universitair Ziekenhuis Antwerpen
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Leuven, Belgium, 3000
- UZ Leuven
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Alberta
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Calgary, Alberta, Canada, T3B6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 2B7
- Stollery Children's Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
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Ontario
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Markham, Ontario, Canada, L3P 7P3
- Markham Stouffville Hosp
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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West Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- McGill Uni Health Ctre - Glen Site
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Montreal, Quebec, Canada, H2J 1K1
- Maison de Sante Prevention
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Aarhus, Denmark, 8200
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus
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Gistrup, Denmark, 9260
- Aalborg Universitetshospital - Børne og Ungeafdelingen
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Holbæk, Denmark, 4300
- Holbæk Sygehus - Børne- og Ungeafdelingen
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Lille, France, 59037
- Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre
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Nice, France, 06200
- Fondation Lenval Nice
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Paris, France, 75012
- Ap-Hp_Hopital Armand Trousseau
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Rouen, France, 76031
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
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Toulouse, France, 31059
- Hopital Des Enfants
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Bochum, Germany, 44791
- Kath. Klinikum Bochum gGmbH - Kinderklinik St. Josef-Hospital
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Göttingen, Germany, 37075
- Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin
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Göttingen, Germany, 37075
- Uni-Med. Göttingen - Klinik für Kinder- und Jugendmedizin
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Hanover, Germany, 30173
- Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung
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Hanover, Germany, 30173
- Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
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Leipzig, Germany, 04103
- Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
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Leipzig, Germany, 04103
- Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
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Ulm, Germany, 89075
- Universitätsklinikum Ulm für Kinder- und Jugendmedizin
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Ulm, Germany, 89075
- Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
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Athens, Greece, 12462
- U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
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Goudi/Athens, Greece, 115-27
- P & A Kyriakou Childrens' Hospital - Department of Endocrinology Growth and Development
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Pátrai, Greece, 26504
- General University of Patra - Paediatric Department
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Thessaloniki, Greece, 546-42
- 'Ippokrateio' General Hospital of Thessaloniki
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Thessaloniki, Greece, 54642
- Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
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Milan, Italy, 20154
- Ospedale dei Bambini "Vittore Buzzi"
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Roma, Italy, 00165
- Ospedale Pediatrico Bambino Gesù
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Trieste, Italy, 34137
- IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
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Verona, Italy, 37126
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
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Tuscany
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Florence, Tuscany, Italy, 50139
- IRCCS Meyer Firenze
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Puebla City, Mexico, 72190
- Consultorio de Endocrinología y Pediatría
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64060
- CHRISTUS - Latam Hub Excellence and Innovation Center
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Tamaulipas
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Ciudad Madero, Tamaulipas, Mexico, 89440
- Centro de Estudios de Investigación Metabólicos y Cardio
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Gdansk, Poland, 80-803
- COPERNICUS Podmiot Leczniczy Sp. z o.o.
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Katowice, Poland, 40-752
- Górnośląskie Centrum Zdrowia Dziecka Im. Św. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 SUM w Katowicach
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Lodz, Poland, 92-213
- UMED Clinical Trials sp. z o.o.
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Rzeszów, Poland, 35-301
- Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
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Stanisławow Pierwszy Nieporet, Poland, 05-126
- ELIPSA - Elzbieta Lipska praktyka lekarska Osrodek Endokrynologii i Diabetologii Dzieciecej
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Warsaw, Poland, 04-730
- Instytut ''Pomnik - Centrum Zdrowia Dziecka''
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Zabrze, Poland, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Poland, 50-368
- Klinika Pediatrii, Endokrynologii, Diabetologii I chorób Metabolicznych, Uniwersyteckiego Szpitala Klinicznego in Wrocław
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Al Ahsa, Saudi Arabia, 36428
- King Abdulaziz Hospital-Al Ahsa-National Guard
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Jeddah, Saudi Arabia, 22384
- National Guard Hospital - Jeddah
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Riyadh, Saudi Arabia, 12372
- King Khaled University Hospital,King Saud Univ. Med. City
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Riyadh, Saudi Arabia, 12713
- King Faisal Specialist Hospital & Research Centre, Riyadh
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Riyadh, Saudi Arabia, 14611
- National Guard Hospital_Riyadh
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Falun, Sweden, 791 37
- Falu Lasarett - Barn- och ungdomsmedicinsk mottagning
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Halmstad, Sweden, 30233
- Hallands sjukhus Halmstad
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Malmö, Sweden, 205 02
- Skåne US Malmö - Barnöverviktsenheten
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Sundsvall, Sweden, 85643
- Sundsvalls sjukhus - Barn- och ungdomsmed mott
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Uppsala, Sweden, 75185
- Uppsala universitetssjukhus
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Birmingham, United Kingdom, B4 6NH
- Birmingham Children's Hospital
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Bristol, United Kingdom, BS2 8AE
- University Hospitals Bristol & Weston NHS Foundation Trust
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Leeds, United Kingdom, LS1 3EX
- Leeds Children's Hospital
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Liverpool, United Kingdom, L12 2AP
- Alder Hey Children's Hospital
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London, United Kingdom, NW1 1BU
- University College Hospital - Paediatric Services
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Sheffield, United Kingdom, S10 2TH
- Sheffield Children's Hospital
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Southampton, United Kingdom, SO16 6YD
- Southampton General Hospital
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California
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Escondido, California, United States, 92025
- Neighborhood Healthcare
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Florida
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Orlando, Florida, United States, 32801
- Clinical Neuroscience Solution
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Tallahassee, Florida, United States, 32308
- TMH Physician Partners Endo
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Georgia
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Atlanta, Georgia, United States, 30329
- Children's Healthcare Atlanta
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Columbus, Georgia, United States, 31904
- Columbus Research Foundation
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Snellville, Georgia, United States, 30078
- Eastside Bariatric and Gen Surg
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Idaho
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Meridian, Idaho, United States, 83646
- Solaris Clinical Research
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Illinois
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Chicago, Illinois, United States, 60602
- Synexus Clinical Research US Inc.-Chicago
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Indiana
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Indianapolis, Indiana, United States, 46505
- Indiana University Hospital
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biom Res Ctr
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Maryland
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Baltimore, Maryland, United States, 21229
- Barry J. Reiner, MD LLC
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- University of Minnesota
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Mississippi
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Madison, Mississippi, United States, 39110
- Mississippi CTR for ADV MED
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New York
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Buffalo, New York, United States, 14203
- UBMD Peds-Div of Endo/Diabetes
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North Carolina
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Raleigh, North Carolina, United States, 27610
- WakeMed Childn Endo-Dbt_Raleig
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North Dakota
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Fargo, North Dakota, United States, 58104
- Valley Weight Loss Clinic
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Ohio
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Columbus, Ohio, United States, 43213
- Centricity Research - Ohio
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Dayton, Ohio, United States, 45429
- Primed Clinical Research
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- UPMC Child Hosp-Pittsburgh
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South Carolina
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North Charleston, South Carolina, United States, 29405
- Coastal Carolina Research Ctr
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Tennessee
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Memphis, Tennessee, United States, 38119
- Clinical Neuroscience Solutions
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Texas
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas Inc
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San Antonio, Texas, United States, 78207-5209
- Texas Diabetes Institute
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Virginia
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Newport News, Virginia, United States, 23606
- Health Res of Hampton Roads
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth Univ
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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:
- 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
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
|
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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
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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
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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