Clinical trial NCT06571383: STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss
Official title: Weight Maintenance in Adolescents With Obesity; Long-Term Treatment With Semaglutide s.c.2.4 mg Once-weekly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maintenance of Body Mass Index (BMI) below obesity threshold
timeFrame: From 1.5 years to 3 years
Secondary outcomes:
measure: Maintenance of improved Body Mass Index (BMI) category
timeFrame: From 1.5 years to 3 years and end of continued treatment phase (up to 6 years)
measure: Tapering to zero dose
timeFrame: From 1.5 years to 3 years
measure: Time/dose steps before ending dose tapering
timeFrame: From 1.5 years to 3 years
measure: Achieving Body Mass Index (BMI) below obesity threshold
timeFrame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
measure: Achieving any improvement in Body Mass Index (BMI) category
timeFrame: From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years)
measure: Change in Body Mass Index (BMI)
timeFrame: From baseline (day 0) to 1.5 and 3 years
measure: Body Mass Index (BMI) percentage of the 95th percentile
timeFrame: From baseline (day 0) to 1.5 and 3 years
measure: Change in Body Mass Index Standard Deviation Score (BMI SDS)
timeFrame: From baseline (day 0) to 1.5 and 3 years
measure: Change in waist-to-height ratio (waist [cm]/ height [cm])
timeFrame: From baseline (day 0) to 1.5 and 3 years
measure: Change in waist circumference
timeFrame: From baseline (day 0) to 1.5 and 3 years
measure: Change in HbA1c
timeFrame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
measure: Change in fasting plasma glucose
timeFrame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
measure: Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
measure: Change in high sensitivity C-reactive protein (hsCRP)
timeFrame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
measure: Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides
timeFrame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
measure: Change in systolic and diastolic blood pressure
timeFrame: From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)
measure: Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass
timeFrame: From baseline (day 0) to 1.5 and 3 years
measure: Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass
timeFrame: From baseline (day 0) to 1.5 and 3 years
measure: Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA)
timeFrame: From baseline (day 0) to 1.5 and 3 years
measure: Serious Adverse Event (SAE)
timeFrame: 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)
Other outcomes:
Locations:
city: Escondido
country: United States
facility: Neighborhood Healthcare
state: California
city: Orlando
country: United States
facility: Clinical Neuroscience Solution
state: Florida
city: Tallahassee
country: United States
facility: TMH Physician Partners Endo
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare Atlanta
state: Georgia
city: Columbus
country: United States
facility: Columbus Research Foundation
state: Georgia
city: Snellville
country: United States
facility: Eastside Bariatric and Gen Surg
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Synexus Clinical Research US Inc.-Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Iowa City
country: United States
facility: University Of Iowa Hospitals and Clinics
state: Iowa
city: Baton Rouge
country: United States
facility: Pennington Biom Res Ctr
state: Louisiana
city: Baltimore
country: United States
facility: Barry J. Reiner, MD LLC
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Madison
country: United States
facility: Mississippi CTR for ADV MED
state: Mississippi
city: Buffalo
country: United States
facility: UBMD Peds-Div of Endo/Diabetes
state: New York
city: Buffalo
country: United States
facility: UBMD Peds-Div of Endo/Diabetes
state: New York
city: Raleigh
country: United States
facility: WakeMed Childn Endo-Dbt_Raleig
state: North Carolina
city: Fargo
country: United States
facility: Valley Weight Loss Clinic
state: North Dakota
city: Columbus
country: United States
facility: Centricity Research - Ohio
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Child Hosp-Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Child Hosp-Pittsburgh
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Ctr
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: San Antonio
country: United States
facility: Texas Diabetes Institute
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc
state: Texas
city: Newport News
country: United States
facility: Health Res of Hampton Roads
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth Univ
state: Virginia
city: Brussel
country: Belgium
facility: UZ Brussel - Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Edegem
country: Belgium
facility: UZA - Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: Uz Leuven
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Markham
country: Canada
facility: Markham Stouffville Hosp
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: West Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Maison de Sante Prevention
state: Quebec
city: Montreal
country: Canada
facility: McGill Uni Health Ctre - Glen Site
state: Quebec
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Steno Diabetes Center Aarhus
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Lille Cedex
country: France
facility: Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre
city: Lille Cedex
country: France
facility: Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre
city: Nice
country: France
facility: Fondation Lenval Nice
city: Paris
country: France
facility: Ap-Hp-Hopital Armand Trousseau
city: Rouen cedex
country: France
facility: Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
city: Rouen cedex
country: France
facility: Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
city: Toulouse Cedex 9
country: France
facility: Hopital Des Enfants-1
city: Bochum
country: Germany
facility: Kinderkrankenhaus Bochum
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen - Klinik für Kinder-und Jugendmedizin
city: Hannover
country: Germany
facility: Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
city: Hannover
country: Germany
facility: Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
city: Ulm
country: Germany
facility: Deutsches Zentrum für Kinder- und Jugendgesundheit (DZKJ)
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm für Kinder- und Jugendmedizin
city: Athens
country: Greece
facility: U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
city: Goudi/Athens
country: Greece
facility: P & A Kyriakou Childrens' Hospital
city: Patra
country: Greece
facility: General University of Patra - Paediatric Department
city: Thessaloniki
country: Greece
facility: 'Ippokrateio' General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
city: Florence
country: Italy
facility: IRCCS Meyer Firenze
state: Toscana
city: Milan
country: Italy
facility: Ospedale dei Bambini "Vittore Buzzi"
city: Roma
country: Italy
facility: Bambin Gesù
city: Trieste
country: Italy
facility: IRCCS materno infantile Burlo Garofolo
city: Verona
country: Italy
facility: AOU Integrata di Verona - Ospedale Civile Maggiore
city: Monterrey
country: Mexico
facility: CHRISTUS - Latam Hub Excellence and Innovation Center
state: Nuevo León
city: Ciudad Madero
country: Mexico
facility: Centro de Estudios de Investigación Metabólicos y Cardio
state: Tamaulipas
city: Puebla
country: Mexico
facility: Consultorio de Endocrinología y Pediatría
city: Puebla
country: Mexico
facility: Consultorio de Endocrinología y Pediatría
city: Wrocław
country: Poland
facility: Klinika Pediatrii, Endokrynologii, Diabetologii I chorób Metabolicznych, Uniwersyteckiego Szpitala Klinicznego in Wrocław
state: Dolnośląskie
city: Gdańsk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o.o.
city: Katowice
country: Poland
facility: Górnośląskie Centrum Zdrowia Dziecka Im. Św. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 SUM w Katowicach
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
city: Stanisławów Pierwszy Nieporęt
country: Poland
facility: ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej
city: Warszawa
country: Poland
facility: Instytut ''Pomnik - Centrum Zdrowia Dziecka''
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
city: Łódź
country: Poland
facility: UMED Clinical Trials sp. z o.o.
city: Al Ahsa
country: Saudi Arabia
facility: King Abdulaziz Hospital-Al Ahsa-National Guard
city: Jeddah
country: Saudi Arabia
facility: National Guard Hospital - Jeddah
city: Riyadh
country: Saudi Arabia
facility: King Khaled University Hospital,King Saud Univ. Med. City
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre, Riyadh
city: Riyadh
country: Saudi Arabia
facility: National Guard Hospital_Riyadh
city: Falun
country: Sweden
facility: Barn- och ungdomsmedicinsk mottagning Falun lasarett
city: Halmstad
country: Sweden
facility: Hallands sjukhus Halmstad
city: Malmö
country: Sweden
facility: Barnöverviktsenheten, SUS Malmö
city: Sundsvall
country: Sweden
facility: Sundsvalls sjukhus
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset Uppsala
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol & Weston NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Children's Hospital
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
city: London
country: United Kingdom
facility: Paediatric Services - UCL
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: