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HomeTrials › NCT06571383

Obesity & weight · Phase 4 · Active, not recruiting

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 · Sponsor: Novo Nordisk A/S

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Semaglutide for obesity.

Who can joinAll sexes, 12 Years – 15 Years
Healthy volunteersNo — diagnosis required
What you'd takeSemaglutide
Study length~4.2 years overall
Planned participants500
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

California

  • Neighborhood Healthcare — Escondido

Florida

  • Clinical Neuroscience Solution — Orlando
  • TMH Physician Partners Endo — Tallahassee

Georgia

  • Children's Healthcare Atlanta — Atlanta
  • Columbus Research Foundation — Columbus
  • Eastside Bariatric and Gen Surg — Snellville

Idaho

  • Solaris Clinical Research — Meridian

Illinois

  • Synexus Clinical Research US Inc.-Chicago — Chicago

Indiana

  • Indiana University Hospital — Indianapolis

Iowa

  • University Of Iowa Hospitals and Clinics — Iowa City

Louisiana

  • Pennington Biom Res Ctr — Baton Rouge

Maryland

  • Barry J. Reiner, MD LLC — Baltimore

Minnesota

  • University of Minnesota — Minneapolis

Mississippi

  • Mississippi CTR for ADV MED — Madison

New York

  • UBMD Peds-Div of Endo/Diabetes — Buffalo

North Carolina

  • WakeMed Childn Endo-Dbt_Raleig — Raleigh

North Dakota

  • Valley Weight Loss Clinic — Fargo

Ohio

  • Centricity Research - Ohio — Columbus
  • PriMed Clinical Research — Dayton

Pennsylvania

  • UPMC Child Hosp-Pittsburgh — Pittsburgh

South Carolina

  • Coastal Carolina Research Ctr — North Charleston

Tennessee

  • Clinical Neuroscience Solutions — Memphis

Texas

  • Texas Diabetes Institute — San Antonio
  • Clinical Trials of Texas Inc — San Antonio

Virginia

  • Health Res of Hampton Roads — Newport News
  • Virginia Commonwealth Univ — Richmond

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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