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

Running, not enrolling · Phase 4

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06571383

Run by

Novo Nordisk A/S

People needed

500

Starts

2024-09-17

Expected to finish

2031-11-15

Last updated by the study team

2026-06-02

Who can join

Age: 12 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements
• 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

You may not qualify if…

• 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:
• Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening
• Adjustable gastric banding, if the band has been removed more than 1 year prior to screening
• Intragastric balloon, if the balloon has been removed more than 1 year prior to screening
• 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 it is running

• 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
• Neighborhood Healthcare — Escondido, California, United States

Full record on ClinicalTrials.gov

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