StudyFinder
STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss
RECRUITING
12 years to 15 years old
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
• 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
DRUG: Semaglutide
Obesity
Novo Nordisk - clinicaltrials@novonordisk.com
PHASE4
NCT06571383