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

Description

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.

Conditions

Obesity

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Escondido

Neighborhood Healthcare, Escondido, California, United States, 92025

Orlando

Clinical Neuroscience Solution, Orlando, Florida, United States, 32801

Tallahassee

TMH Physician Partners Endo, Tallahassee, Florida, United States, 32308

Atlanta

Children's Healthcare Atlanta, Atlanta, Georgia, United States, 30329

Columbus

Columbus Research Foundation, Columbus, Georgia, United States, 31904

Snellville

Eastside Bariatric and Gen Surg, Snellville, Georgia, United States, 30078

Meridian

Solaris Clinical Research, Meridian, Idaho, United States, 83646

Chicago

Synexus Clinical Research US Inc.-Chicago, Chicago, Illinois, United States, 60602

Indianapolis

Indiana University Hospital, Indianapolis, Indiana, United States, 46505

Iowa City

University Of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

12 Years to 15 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novo Nordisk A/S,

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

2031-11-15