Solaris Clinical Research | Meridian, ID
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About
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 injection. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. All participants will get semaglutide treatment for a minimum of 3 years.
Enrollment
Sex
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Volunteers
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:
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:
Endocrine, hypothalamic, or syndromic obesity
History of type 1 or type 2 diabetes mellitus
Primary purpose
Allocation
Interventional model
Masking
500 participants in 1 patient group
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Central trial contact
Novo Nordisk
Data sourced from clinicaltrials.gov
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