4512: A research study on how well semaglutide helps children and teenagers with excess body weight
Research type
Research Study
Full title
NN9536-4512: Long-term safety and efficacy of semaglutide s.c. once-weekly on weight management in children and adolescents (aged 6 to <18 years) with obesity or overweight
IRAS ID
1007414
Contact name
Clinical Transparency
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2022-502922-41
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate the effect and safety of once-weekly subcutaneous (s.c.) treatment of semaglutide compared to placebo in children (ages 6 to <12 years) with obesity. Additionally, the study compares the long-term (2 years) safety and tolerability of semaglutide s.c. versus placebo in children (ages 6 to <12 years) with obesity, and adolescents (ages 12 to <18 years) with obesity, or overweight with one or more weight-related comorbidity. The children will be randomised to receive either semaglutide or placebo for 104 weeks followed by a 26-week off-trial product, follow-up period. Children will need to attend the clinic 35 times during the entire course of the study where various assessments will be undertaken.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0364
Date of REC Opinion
29 Aug 2023
REC opinion
Further Information Favourable Opinion