Weight Maintenance in Adolescents With Obesity; Long-Term Treatment With Semaglutide s.c.2.4 mg Once-weekly

简要总结

主要结局

次要结局

• Maintenance of improved Body Mass Index (BMI) category(From 1.5 years to 3 years and end of continued treatment phase (up to 6 years))
• Tapering to zero dose(From 1.5 years to 3 years)
• Time/dose steps before ending dose tapering(From 1.5 years to 3 years)
• Achieving Body Mass Index (BMI) below obesity threshold(From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years))
• Achieving any improvement in Body Mass Index (BMI) category(From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years))
• Change in Body Mass Index (BMI)(From baseline (day 0) to 1.5 and 3 years)
• Body Mass Index (BMI) percentage of the 95th percentile(From baseline (day 0) to 1.5 and 3 years)
• Change in Body Mass Index Standard Deviation Score (BMI SDS)(From baseline (day 0) to 1.5 and 3 years)
• Change in waist-to-height ratio (waist [cm]/ height [cm])(From baseline (day 0) to 1.5 and 3 years)
• Change in waist circumference(From baseline (day 0) to 1.5 and 3 years)
• Change in HbA1c(From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years))
• Change in fasting plasma glucose(From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years))
• Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years))
• Change in high sensitivity C-reactive protein (hsCRP)(From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years))
• Change in systolic and diastolic blood pressure(From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years))
• Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass(From baseline (day 0) to 1.5 and 3 years)
• Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass(From baseline (day 0) to 1.5 and 3 years)
• Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA)(From baseline (day 0) to 1.5 and 3 years)
• Serious Adverse Event (SAE)(From baseline (day 0) to 1.5 years, from 1.5 to 3 years, and from 3 years to end of continued treatment phase (up to 6 years))
• Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides(From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years))