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

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

Weight Maintenance in Adolescents With Obesity; Long-Term Treatment With Semaglutide s.c.2.4 mg Once-weekly

NCT06571383•Novo Nordisk A/S

View on ClinicalTrials.gov

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

Age

12 - 15 years

Sex

ALL

Healthy Volunteers

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

Locations (93)

Neighborhood Healthcare

Escondido, California, United States

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

Key Dates

Start Date

September 17, 2024

Primary Completion Date

November 15, 2028

Completion Date

November 15, 2031

Last Updated

December 18, 2025

Enrollment

500

ESTIMATED participants

Conditions

Obesity

Interventions

Semaglutide

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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