Status:
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity
Eligibility:
All Genders
12-15 years
Phase:
PHASE4
Brief 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 in...
Eligibility Criteria
Inclusion
- 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:
- The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements
- 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:
- Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening
- Adjustable gastric banding, if the band has been removed more than 1 year prior to screening
- Intragastric balloon, if the balloon has been removed more than 1 year prior to screening
- 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
Exclusion
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2031
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06571383
Start Date
September 17 2024
End Date
November 15 2031
Last Update
December 18 2025
Active Locations (93)
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