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

Talk to us

Conditions

Obesity

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-17
Study Completion:2031-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06571383

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.

Ages Eligible for Study:12 Years to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. 1. The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements
  3. 2. The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements
  4. * Age 12 to less than 15 years at the time of signing the informed consent
  5. * BMI greater than or equal to 95th percentile at screening
  6. * Body weight greater than 60 kg at screening
  1. * Prepubertal status (Tanner stage 1)
  2. * Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
  3. * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
  4. 1. Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening
  5. 2. Adjustable gastric banding, if the band has been removed more than 1 year prior to screening
  6. 3. Intragastric balloon, if the balloon has been removed more than 1 year prior to screening
  7. 4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed more than 1 year prior to screening
  8. * Endocrine, hypothalamic, or syndromic obesity
  9. * History of type 1 or type 2 diabetes mellitus

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Clinical Neuroscience Solution
Orlando, Florida, 32801
United States
TMH Physician Partners Endo
Tallahassee, Florida, 32308
United States
Children's Healthcare Atlanta
Atlanta, Georgia, 30329
United States
Columbus Research Foundation
Columbus, Georgia, 31904
United States
Eastside Bariatric and Gen Surg
Snellville, Georgia, 30078
United States
Solaris Clinical Research
Meridian, Idaho, 83646
United States
University Of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Pennington Biom Res Ctr
Baton Rouge, Louisiana, 70808
United States
Barry J. Reiner, MD LLC
Baltimore, Maryland, 21229
United States
University of Minnesota
Minneapolis, Minnesota, 55414
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, 14203
United States
WakeMed Childn Endo-Dbt_Raleig
Raleigh, North Carolina, 27610
United States
Valley Weight Loss Clinic
Fargo, North Dakota, 58104
United States
Centricity Research - Ohio
Columbus, Ohio, 43213
United States
PriMed Clinical Research
Dayton, Ohio, 45429
United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Coastal Carolina Research Ctr
North Charleston, South Carolina, 29405
United States
Texas Diabetes Institute
San Antonio, Texas, 78207-5209
United States
Clinical Trials of Texas Inc
San Antonio, Texas, 78229
United States
Health Res of Hampton Roads
Newport News, Virginia, 23606
United States
Virginia Commonwealth Univ
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17
Study Completion Date2031-11-15

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2031-11-15

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity