STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss
NCT Number: NCT06571383
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Obesity
Interventions: DRUG: Semaglutide
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: CHILD
Enrollment: 500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-17
Completion Date: 2031-11-15
Locations: Neighborhood Healthcare, Escondido, California, 92025, United States|Clinical Neuroscience Solution, Orlando, Florida, 32801, United States|TMH Physician Partners Endo, Tallahassee, Florida, 32308, United States|Children's Healthcare Atlanta, Atlanta, Georgia, 30329, United States|Columbus Research Foundation, Columbus, Georgia, 31904, United States|Eastside Bariatric and Gen Surg, Snellville, Georgia, 30078, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Synexus Clinical Research US Inc.-Chicago, Chicago, Illinois, 60602, United States|Indiana University of Medicine, Indianapolis, Indiana, 46202, United States|University Of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States|Pennington Biom Res Ctr, Baton Rouge, Louisiana, 70808, United States|Barry J. Reiner, MD LLC, Baltimore, Maryland, 21229, United States|University of Minnesota, Minneapolis, Minnesota, 55414, United States|Mississippi CTR for ADV MED, Madison, Mississippi, 39110, United States|UBMD Peds-Div of Endo/Diabetes, Buffalo, New York, 14203, United States|WakeMed Childn Endo-Dbt_Raleig, Raleigh, North Carolina, 27610, United States|Valley Weight Loss Clinic, Fargo, North Dakota, 58104, United States|Centricity Research - Ohio, Columbus, Ohio, 43213, United States|PriMed Clinical Research, Dayton, Ohio, 45429, United States|UPMC Child Hosp-Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|Coastal Carolina Research Ctr, North Charleston, South Carolina, 29405, United States|Clinical Neuroscience Solutions, Memphis, Tennessee, 38119, United States|Texas Diabetes Institute, San Antonio, Texas, 78207-5209, United States|Clinical Trials of Texas Inc, San Antonio, Texas, 78229, United States|Health Res of Hampton Roads, Newport News, Virginia, 23606, United States|Virginia Commonwealth Univ, Richmond, Virginia, 23298, United States|Cliniques universitaires Saint-Luc, Bruxelles, 1200, Belgium|Alberta Children's Hospital, Calgary, Alberta, T3B 6A8, Canada|Walter C. Mackenzie Hlth Sci Ctr, Edmonton, Alberta, T6G 2E1, Canada|BC Children's Hospital, Vancouver, Bristish Columbia, V6H 3V4, Canada|Hamilton Health Sciences Corp, Ontario, Hamilton, Ontario, L8N 3Z5, Canada|Markham Stouffville Hosp, Markham, Ontario, L6B0T1, Canada|The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|McGill Uni Health Ctre - Glen Site, Montreal, Quebec, H4V 1J3, Canada|Aalborg Universitetshospital, Aalborg, 9000, Denmark|Aarhus Universitetshospital, Steno Diabetes Center Aarhus, Aarhus, 8200, Denmark|Holbæk Sygehus, Holbæk, 4300, Denmark|Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre, Lille Cedex, 59037, France|Fondation Lenval Nice, Nice, 06200, France|Ap-Hp-Hopital Armand Trousseau, Paris, 75012, France|Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle, Rouen cedex, 76031, France|Kinderkrankenhaus Bochum, Bochum, 44791, Germany|Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin, Göttingen, 37075, Germany|Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, 30173, Germany|Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin, Leipzig, 04103, Germany|Universitätsklinikum Ulm für Kinder- und Jugendmedizin, Ulm, 89075, Germany|P & A Kyriakou Childrens' Hospital, Goudi/Athens, 115-27, Greece|U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic, Haidari-Athens, GR-12462, Greece|General University of Patra - Paediatric Department, Patra, 26504, Greece|Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic, Thessaloniki, GR 54642, Greece|'Ippokrateio' General Hospital of Thessaloniki, Thessaloniki, GR546-42, Greece|IRCCS Meyer Firenze, Florence, 50139, Italy|Ospedale dei Bambini "Vittore Buzzi", Milan, 20154, Italy|Bambin Gesù, Roma, 00165, Italy|IRCCS materno infantile Burlo Garofolo, Trieste, 34137, Italy|AOU Integrata di Verona - Ospedale Civile Maggiore, Verona, 37126, Italy|CHRISTUS - Latam Hub Excellence and Innovation Center, Monterrey, Nuevo León, 64060, Mexico|Centro de Estudios de Investigación Metabólicos y Cardio, Ciudad Madero, Tamaulipas, 89440, Mexico|Consultorio de Endocrinología y Pediatría, Puebla, 72190, Mexico|Klinika Pediatrii, Endokrynologii, Diabetologii I chorób Metabolicznych, Uniwersyteckiego Szpitala Klinicznego in Wrocław, Wrocław, Dolnośląskie, 50-368, Poland|Copernicus Podmiot Leczniczy Sp. z o.o., Gdańsk, 80-803, Poland|Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie, Rzeszów, 35-301, Poland|ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej, Stanisławów Pierwszy Nieporęt, 05-126, Poland|Instytut ''Pomnik - Centrum Zdrowia Dziecka'', Warszawa, 04-730, Poland|Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko, Zabrze, 41-800, Poland|UMED Clinical Trials sp. z o.o., Łódź, 92-213, Poland|Hallands sjukhus Halmstad, Halmstad, 30233, Sweden|Barnöverviktsenheten, SUS Malmö, Malmö, 205 02, Sweden|Sundsvalls sjukhus, Sundsvall, 85643, Sweden|Akademiska sjukhuset Uppsala, Uppsala, 71525, Sweden

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.

Primary Outcome Measures: Maintenance of Body Mass Index (BMI) below obesity threshold, Measures as count of participants, From 1.5 years to 3 years
Secondary Outcome Measures: Maintenance of improved Body Mass Index (BMI) category, 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, Measured as count of participants, From 1.5 years to 3 years|Time/dose steps before ending dose tapering, Measured in weeks, count of dose steps, From 1.5 years to 3 years|Achieving Body Mass Index (BMI) below obesity threshold, 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, 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), Measured in percentage (%), From baseline (day 0) to 1.5 and 3 years|Body Mass Index (BMI) percentage of the 95th percentile, Measured in percentage (%), From baseline (day 0) to 1.5 and 3 years|Change in Body Mass Index Standard Deviation Score (BMI SDS), Unitless, From baseline (day 0) to 1.5 and 3 years|Change in waist-to-height ratio (waist [cm]/ height [cm]), Unitless, From baseline (day 0) to 1.5 and 3 years|Change in waist circumference, Measured in centimeters (cm), From baseline (day 0) to 1.5 and 3 years|Change in HbA1c, 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, 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), 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), 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, 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, 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, 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, Measured in percentage (%) points, From baseline (day 0) to 1.5 and 3 years|Change in visceral fat mass, by dual X-ray absorptiometry (DXA), Measured in percentage (%) points, From baseline (day 0) to 1.5 and 3 years|Serious Adverse Event (SAE), 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)