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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 56
- 主要终点
- Group Kids: Change in body mass index (BMI)
研究概览
简要总结
This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults.
The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, 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. a) The parents or LAR of the child must sign and date the Informed Consent Form (according to local requirements) b) The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
- •Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years. b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1
- •Body mass index (BMI), at screening and randomisation, corresponding to a) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (T2D)
- •History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months
- •Body weight of greater than 45 kilogram (kg) at screening and randomisation
- •For participants with T2D at screening, the following additional criterion applies: glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening
排除标准
- •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: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve has been removed greater than 1 year prior to screening
- •Type 1 diabetes mellitus or monogenic diabetes
- •Participants with endocrine, hypothalamic, or syndromic obesity
- •For participants with T2D at screening, the following additional key criterion applies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
研究组 & 干预措施
Group Kids
Participants in the age group 6 to less than (<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Placebo (Drug)
Group Teens
Participants in the age group 12 to < 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Semaglutide (Drug)
Group Teens
Participants in the age group 12 to < 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Placebo (Drug)
Group Kids
Participants in the age group 6 to less than (<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Group Kids: Change in body mass index (BMI)
时间窗: From baseline (week 0) to week 68
Measured in percentage (%)
次要结局
- Group Kids and Group Teens: Change in body weight(From week 0 to week 68)
- Group Kids and Group Teens: Change in body weight(From week 0 to week 104)
- Group Kids and Group Teens: Change in fasting plasma glucose(From week 0 to week 104)
- Group Kids and Group Teens: Change in BMI percentage of the 95th percentile(From week 0 to week 68)
- Group Kids and Group Teens: Change in waist circumference(From week 0 to week 68)
- Group Kids and Group Teens: Change in systolic blood pressure(From week 0 to week 68)
- Group Kids and Group Teens: Change in diastolic blood pressure(From week 0 to week 68)
- Group Kids and Group Teens: Change in total cholesterol(From week 0 to week 68)
- Group Kids and Group Teens: Change in high density lipoprotein (HDL)(From week 0 to week 68)
- Group Kids and Group Teens: Change in low density lipoprotein (LDL)(From week 0 to week 68)
- Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)(From week 0 to week 68)
- Group Kids and Group Teens: Change in triglycerides(From week 0 to week 68)
- Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)(From week 0 to week 68)
- Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)(From week 0 to week 68)
- Group Kids and Group Teens: Change in fasting plasma glucose(From week 0 to week 68)
- Group Kids and Group Teens: Change in fasting insulin(From week 0 to week 68)
- Group Kids and Group Teens: Change in alanine transaminase (ALT)(From week 0 to week 68)
- Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass(From week 0 to week 68)
- Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass(From week 0 to week 68)
- Group Kids and Group Teens: Relative change in visceral fat mass by DXA(From week 0 to week 68)
- Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)(From week 0 to week 68)
- Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)(From week 0 to week 68)
- Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)(From week 0 to week 68)
- Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)(From week 0 to week 68)
- Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)(From week 0 to week 68)
- Group Kids and Group Teens: Change in pulse(From week 0 to week 68)
- Group Kids and Group Teens: Change in amylase(From week 0 to week 68)
- Group Kids and Group Teens: Change in lipase(From week 0 to week 68)
- Group Kids and Group Teens: Change in calcitonin(From week 0 to week 68)
- Group Kids and Group Teens: Change in bone mineral density, by DXA(From week 0 to week 68)
- Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)(From week 0 to week 68)
- Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)(From week 0 to week 104)
- Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass(From week 0 to week 104)
- Group Kids and Group Teens: Relative change in visceral fat mass by DXA(From week 0 to week 104)
- Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)(From week 0 to week 104)
- Group Kids: Improvement in weight category(From baseline (week 0) to week 68)
- Group Teens: Change in BMI(From week 0 to week 68)
- Group Kids and Group Teens: Change in BMI(From week 0 to week 104)
- Group Teens: Improvement in weight category(From week 0 to week 68)
- Group Kids and Group Teens: Change in BMI percentage of the 95th percentile(From week 0 to week 104)
- Group Kids and Group Teens: Change in BMI Standard deviation score (SDS)(From week 0 to week 68)
- Group Kids and Group Teens: Change in waist circumference(From week 0 to week 104)
- Group Kids and Group Teens: Improvement in weight category(From week 0 to week 104)
- Group Kids and Group Teens: Change in BMI SDS(From week 0 to week 104)
- Group Kids and Group Teens: Change in systolic blood pressure(From week 0 to week 104)
- Group Kids and Group Teens: Change in diastolic blood pressure(From week 0 to week 104)
- Group Kids and Group Teens: Change in total cholesterol(From week 0 to week 104)
- Group Kids and Group Teens: Change in high density lipoprotein (HDL)(From week 0 to week 104)
- Group Kids and Group Teens: Change in low density lipoprotein (LDL)(From week 0 to week 104)
- Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)(From week 0 to week 104)
- Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)(From week 0 to week 104)
- Group Kids and Group Teens: Change in triglycerides(From week 0 to week 104)
- Group Kids and Group Teens: Change in fasting insulin(From week 0 to week 104)
- Group Kids and Group Teens: Change in alanine transaminase (ALT)(From week 0 to week 104)
- Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass(From week 0 to week 104)
- Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)(From week 0 to week 104)
- Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)(From week 0 to week 104)
- Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)(From week 0 to week 111)
- Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)(From week 0 to week 111)
- Group Kids and Group Teens: Change in pulse(From week 0 to week 104)
- Group Kids and Group Teens: Change in amylase(From week 0 to week 104)
- Group Kids and Group Teens: Change in lipase(From week 0 to week 104)
- Group Kids and Group Teens: Change in calcitonin(From week 0 to week 104)
- Group Kids and Group Teens: Change in bone mineral density, by DXA(From week 0 to week 104)
- Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)(From week 0 to week 111)