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Clinical Trials in the UK / NCT06571383
Active, not recruiting Phase 4

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

NCT06571383 · tracked via the Priya Life Science UK tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 4
Started
2024-09-17
Last updated
2026-06-02

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Semaglutide

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

Study 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

Sex
ALL
Min age
12 Years
Max age
15 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (93)

FacilityCityRegionStatus
Neighborhood Healthcare Escondido California
Clinical Neuroscience Solution Orlando Florida
TMH Physician Partners Endo Tallahassee Florida
Children's Healthcare Atlanta Atlanta Georgia
Columbus Research Foundation Columbus Georgia
Eastside Bariatric and Gen Surg Snellville Georgia
Solaris Clinical Research Meridian Idaho
Synexus Clinical Research US Inc.-Chicago Chicago Illinois
Indiana University Hospital Indianapolis Indiana
University Of Iowa Hospitals and Clinics Iowa City Iowa
Pennington Biom Res Ctr Baton Rouge Louisiana
Barry J. Reiner, MD LLC Baltimore Maryland
University of Minnesota Minneapolis Minnesota
Mississippi CTR for ADV MED Madison Mississippi
UBMD Peds-Div of Endo/Diabetes Buffalo New York
WakeMed Childn Endo-Dbt_Raleig Raleigh North Carolina
Valley Weight Loss Clinic Fargo North Dakota
Centricity Research - Ohio Columbus Ohio
PriMed Clinical Research Dayton Ohio
UPMC Child Hosp-Pittsburgh Pittsburgh Pennsylvania
Coastal Carolina Research Ctr North Charleston South Carolina
Clinical Neuroscience Solutions Memphis Tennessee
Texas Diabetes Institute San Antonio Texas
Clinical Trials of Texas Inc San Antonio Texas
Health Res of Hampton Roads Newport News Virginia
Virginia Commonwealth Univ Richmond Virginia
UZ Brussel - Universitair Ziekenhuis Brussel Brussels Belgium
Cliniques universitaires Saint-Luc Brussels Belgium
UZA - Universitair Ziekenhuis Antwerpen Edegem Belgium
Uz Leuven Leuven Belgium
Alberta Children's Hospital Calgary Alberta
Stollery Children's Hospital Edmonton Alberta
BC Children's Hospital Vancouver British Columbia
Markham Stouffville Hosp Markham Ontario
The Hospital for Sick Children Toronto Ontario
McMaster Children's Hospital West Hamilton Ontario
Maison de Sante Prevention Montreal Quebec
McGill Uni Health Ctre - Glen Site Montreal Quebec
Aarhus Universitetshospital, Steno Diabetes Center Aarhus Aarhus Denmark
Aalborg Universitetshospital - Børne og Ungeafdelingen Gistrup Denmark

+ 53 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

More Novo Nordisk A/S trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06571383 on ClinicalTrials.gov ↗ ← All trials in the UK