STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss
Purpose
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.
Condition
- Obesity
Eligibility
- Eligible Ages
- Between 12 Years and 15 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Semaglutide |
2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly |
|
Recruiting Locations
Solaris Clinical Research
Meridian, Idaho 83646
Meridian, Idaho 83646
Pennington Biom Res Ctr
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
Barry J. Reiner, MD LLC
Baltimore, Maryland 21229
Baltimore, Maryland 21229
University of Minnesota
Minneapolis, Minnesota 55414
Minneapolis, Minnesota 55414
Valley Weight Loss Clinic
Fargo, North Dakota 58104
Fargo, North Dakota 58104
Centricity Research - Ohio
Columbus, Ohio 43213
Columbus, Ohio 43213
PriMed Clinical Research
Dayton, Ohio 45429
Dayton, Ohio 45429
Texas Diabetes Institute
San Antonio, Texas 78207-5209
San Antonio, Texas 78207-5209
Health Res of Hampton Roads
Newport News, Virginia 23606
Newport News, Virginia 23606
Virginia Commonwealth Univ
Richmond, Virginia 23298
Richmond, Virginia 23298
More Details
- NCT ID
- NCT06571383
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S