STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss
- Registration Number
- NCT06571383
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Semaglutide Semaglutide 2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly
- Primary Outcome Measures
Name Time Method Maintenance of Body Mass Index (BMI) below obesity threshold From 1.5 years to 3 years Measures as count of participants
- Secondary Outcome Measures
Name Time Method Maintenance of improved Body Mass Index (BMI) category From 1.5 years to 3 years and end of continued treatment phase (up to 6 years) Measured as count of participants
Tapering to zero dose From 1.5 years to 3 years Measured as count of participants
Time/dose steps before ending dose tapering From 1.5 years to 3 years Measured in weeks, count of dose steps
Achieving Body Mass Index (BMI) below obesity threshold From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured as count of participants
Achieving any improvement in Body Mass Index (BMI) category From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years) Measured as count of participants
Change in Body Mass Index (BMI) From baseline (day 0) to 1.5 and 3 years Measured in percentage (%)
Body Mass Index (BMI) percentage of the 95th percentile From baseline (day 0) to 1.5 and 3 years Measured in percentage (%)
Change in Body Mass Index Standard Deviation Score (BMI SDS) From baseline (day 0) to 1.5 and 3 years Unitless
Change in waist-to-height ratio (waist [cm]/ height [cm]) From baseline (day 0) to 1.5 and 3 years Unitless
Change in waist circumference From baseline (day 0) to 1.5 and 3 years Measured in centimeters (cm)
Change in HbA1c From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in percentage (%) points
Change in fasting plasma glucose 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)
Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in percentage (%)
Change in high sensitivity C-reactive protein (hsCRP) From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in percentage (%)
Change in systolic and diastolic blood pressure 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)
Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) Measured in percentage (%)
Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass From baseline (day 0) to 1.5 and 3 years Measured in percentage (%) points
Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass From baseline (day 0) to 1.5 and 3 years Measured in percentage (%) points
Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA) From baseline (day 0) to 1.5 and 3 years Measured in percentage (%)
Serious Adverse Event (SAE) 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
Trial Locations
- Locations (90)
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
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
🇧🇪Brussel, Belgium
Cliniques universitaires Saint-Luc
🇧🇪Bruxelles, 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
🇩🇰Holbæk, Denmark
Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre
🇫🇷Lille Cedex, France
Fondation Lenval Nice
🇫🇷Nice, France
Ap-Hp-Hopital Armand Trousseau
🇫🇷Paris, France
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
🇫🇷Rouen cedex, France
Hopital Des Enfants-1
🇫🇷Toulouse Cedex 9, France
Kinderkrankenhaus Bochum
🇩🇪Bochum, Germany
Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin
🇩🇪Göttingen, Germany
Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
🇩🇪Hannover, Germany
Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
🇩🇪Leipzig, Germany
Deutsches 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
🇬🇷Patra, Greece
'Ippokrateio' General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
🇬🇷Thessaloniki, Greece
IRCCS Meyer Firenze
🇮🇹Florence, Toscana, Italy
Ospedale dei Bambini "Vittore Buzzi"
🇮🇹Milan, Italy
Bambin Gesù
🇮🇹Roma, Italy
IRCCS materno infantile Burlo Garofolo
🇮🇹Trieste, Italy
AOU Integrata di Verona - Ospedale Civile Maggiore
🇮🇹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, Mexico
Klinika Pediatrii, Endokrynologii, Diabetologii I chorób Metabolicznych, Uniwersyteckiego Szpitala Klinicznego in Wrocław
🇵🇱Wrocław, Dolnośląskie, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
🇵🇱Gdańsk, Poland
Górnośląskie Centrum Zdrowia Dziecka Im. Św. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 SUM w Katowicach
🇵🇱Katowice, Poland
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
🇵🇱Rzeszów, Poland
ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej
🇵🇱Stanisławów Pierwszy Nieporęt, Poland
Instytut ''Pomnik - Centrum Zdrowia Dziecka''
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
🇵🇱Zabrze, Poland
UMED Clinical Trials sp. z o.o.
🇵🇱Łódź, 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
Barn- och ungdomsmedicinsk mottagning Falun lasarett
🇸🇪Falun, Sweden
Hallands sjukhus Halmstad
🇸🇪Halmstad, Sweden
Barnöverviktsenheten, SUS Malmö
🇸🇪Malmö, 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