Last updated 37 hours ago
STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss
500 patients around the world
Available in United States, Mexico
Novo Nordisk A/S
2Research sites
500Patients around the world
This study is for people with
Obesity
Requirements for the patient
To 15 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Endocrinología pediátrica Puebla, Dra. Jessica Chantal García Téllez
CHRISTUS Centro de Excelencia en Investigación - CEI (Obispado)
SponsorNovo Nordisk A/S
Conditions
Obesity
Requirements
To 15 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06571383
