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

Launched by NOVO NORDISK A/S · Aug 22, 2024

Keywords

ClinConnect Summary

The STEP TEENS Weight Maintenance study is researching how effective a medication called semaglutide is for helping teenagers with excess body weight lose weight and keep it off. In this trial, participants aged 12 to 14 years who weigh more than 60 kg and have a body mass index (BMI) in the top 5% for their age will receive semaglutide through a weekly injection for at least three years. The injection is given with a small needle in areas like the stomach, thighs, or upper arms.

To join the study, participants need permission from their parents or guardians, and they must also agree to take part. This trial is looking for teenagers who have not recently used other weight loss medications or undergone weight loss surgery. Throughout the study, participants will be monitored to see how well the medication works for weight loss and maintaining a healthier weight. It's a chance for teens struggling with obesity to potentially benefit from a new treatment while contributing to important research.

Gender

ALL

Eligibility criteria

• 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