Using semaglutide to help teenagers with excess weight lose and maintain weight loss
Weight Maintenance in Adolescents With Obesity; Long-Term Treatment With Semaglutide s.c.2.4 mg Once-weekly
This study tests if a weekly injection of semaglutide can help teenagers aged 12 to 15 with excess weight lose weight and keep it off for at least three years.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 12 Years to 15 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 96 sites (Escondido, California and 95 other locations) |
| Trial ID | NCT06571383 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of semaglutide, a medication administered via weekly injections, in helping adolescents aged 12 to 15 with excess body weight achieve weight loss and maintain that loss over a minimum period of three years. Participants will receive semaglutide treatment while being monitored for their weight and overall health. The study aims to provide insights into the long-term benefits of this treatment for obesity in teenagers.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to less than 15 years with a BMI at or above the 95th percentile and a body weight greater than 60 kg.
Not a fit: Patients who are prepubertal or have undergone recent obesity treatments, including surgery or weight loss devices, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve weight management and health outcomes for adolescents struggling with obesity.
How similar studies have performed: Other studies have shown promising results with semaglutide for weight management in adults, suggesting potential success in this adolescent population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Escondido, California and 95 other locations
- Neighborhood Healthcare — Escondido, California, United States (Withdrawn)
- Clinical Neuroscience Solution — Orlando, Florida, United States (Active_not_recruiting)
- TMH Physician Partners Endo — Tallahassee, Florida, United States (Active_not_recruiting)
- Children's Healthcare Atlanta — Atlanta, Georgia, United States (Active_not_recruiting)
- Columbus Research Foundation — Columbus, Georgia, United States (Active_not_recruiting)
- Eastside Bariatric and Gen Surg — Snellville, Georgia, United States (Active_not_recruiting)
- Solaris Clinical Research — Meridian, Idaho, United States (Recruiting)
- Synexus Clinical Research US Inc.-Chicago — Chicago, Illinois, United States (Withdrawn)
- Indiana University Hospital — Indianapolis, Indiana, United States (Withdrawn)
- University Of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Active_not_recruiting)
- Pennington Biom Res Ctr — Baton Rouge, Louisiana, United States (Recruiting)
- Barry J. Reiner, MD LLC — Baltimore, Maryland, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Mississippi CTR for ADV MED — Madison, Mississippi, United States (Withdrawn)
- UBMD Peds-Div of Endo/Diabetes — Buffalo, New York, United States (Active_not_recruiting)
- UBMD Peds-Div of Endo/Diabetes — Buffalo, New York, United States (Not_yet_recruiting)
- WakeMed Childn Endo-Dbt_Raleig — Raleigh, North Carolina, United States (Active_not_recruiting)
- Valley Weight Loss Clinic — Fargo, North Dakota, United States (Recruiting)
- Centricity Research - Ohio — Columbus, Ohio, United States (Recruiting)
- PriMed Clinical Research — Dayton, Ohio, United States (Recruiting)
- UPMC Child Hosp-Pittsburgh — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)
- UPMC Child Hosp-Pittsburgh — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
- Coastal Carolina Research Ctr — North Charleston, South Carolina, United States (Active_not_recruiting)
- Clinical Neuroscience Solutions — Memphis, Tennessee, United States (Withdrawn)
- Texas Diabetes Institute — San Antonio, Texas, United States (Recruiting)
- Clinical Trials of Texas Inc — San Antonio, Texas, United States (Active_not_recruiting)
- Health Res of Hampton Roads — Newport News, Virginia, United States (Recruiting)
- Virginia Commonwealth Univ — Richmond, Virginia, United States (Recruiting)
- UZ Brussel - Universitair Ziekenhuis Brussel — Brussel, Belgium (Recruiting)
- Cliniques universitaires Saint-Luc — Bruxelles, Belgium (Not_yet_recruiting)
- UZA - Universitair Ziekenhuis Antwerpen — Edegem, Belgium (Recruiting)
- Uz Leuven — Leuven, Belgium (Recruiting)
- Alberta Children's Hospital — Calgary, Alberta, Canada (Not_yet_recruiting)
- Stollery Children's Hospital — Edmonton, Alberta, Canada (Recruiting)
- BC Children's Hospital — Vancouver, British Columbia, Canada (Withdrawn)
- Markham Stouffville Hosp — Markham, Ontario, Canada (Not_yet_recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
- McMaster Children's Hospital — West Hamilton, Ontario, Canada (Withdrawn)
- Maison de Sante Prevention — Montreal, Quebec, Canada (Withdrawn)
- McGill Uni Health Ctre - Glen Site — Montreal, Quebec, Canada (Not_yet_recruiting)
- Aalborg Universitetshospital — Aalborg, Denmark (Recruiting)
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus — Aarhus, Denmark (Not_yet_recruiting)
- Holbæk Sygehus — Holbæk, Denmark (Recruiting)
- Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre — Lille Cedex, France (Recruiting)
- Centre Hospitalier Universitaire de Lille-Hopital Jeanne de Flandre — Lille Cedex, France (Not_yet_recruiting)
- Fondation Lenval Nice — Nice, France (Recruiting)
- Ap-Hp-Hopital Armand Trousseau — Paris, France (Recruiting)
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle — Rouen cedex, France (Recruiting)
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle — Rouen cedex, France (Not_yet_recruiting)
- Hopital Des Enfants-1 — Toulouse Cedex 9, France (Not_yet_recruiting)
+46 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.