SYFae3a6a6738894d7f9042adc93c7d54d1Registry ID: 2023-506289-29-00|RecruitingPhase 4
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interventional
N/A
1 country
6
To confirm superiority of once-weekly semaglutide s.c. 2.4 mg versus once-weekly semaglutide s.c. placebo, both as an adjunct to a 52-week blended face-to-face (F2F) and electronic behavioral therapy (eBT) program in treatment-seeking adolescents (12 to <18 years) with obesity on percentage reduction in body weight (% BMI change) [after completion of an initial 8-week blended F2F and electronic LED (eLED)].
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2023
Actual (reported)Percentage change in BMI (Time frame: From week 8 to week 60)
The main secondary endpoints include the number and severity of adverse events, physical activity, sleep, psychiatric symptoms, eating disorder symptoms, and health-related quality of life. In addition, changes in fat mass, fat-free mass, blood glucose, blood lipids, blood pressure, and other cardiometabolic risk factors will be compared between the treatment groups.
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Formulated product
Wegovy 2.4 mg solution for injection in pre-filled syringe
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Wegovy 2.4 mg solution for injection in pre-filled syringe
Named ingredient: Semaglutide
View registry recordSt. Olavs Hospital HF
Trondheim, 7030, Norway
Nordlandssykehuset HF
Bodo, 8005, Norway
Helse Bergen HF
Bergen, 5021, Norway
Hormon, overvekt og ernæringsavdelingen - forskning
First Submitted
August 8, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
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Oslo University Hospital HF
Oslo, 0450, Norway
Vestfold Hospital Trust
Tonsberg, 3103, Norway
Finnmarkssykehuset HF
Hammerfest, 9601, Norway