2023-508055-40-00招募中4 期
Weight Maintenance in Adolescents With Obesity; Long-Term Treatment With Semaglutide s.c. 2.4 mg Once-weekly
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 294
- 试验地点
- 36
- 主要终点
- Maintenance of BMI below obesity threshold. From 1.5 years to 3 years. Count of participant.
研究概览
简要总结
To investigate BMI maintenance with semaglutide administered according to a dose-tapering algorithm in adolescents who have achieved BMI below obesity threshold and are still on-treatment after 1.5 years of initial treatment
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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: - The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements - The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements
- •Age 12 to <15 years at the time of signing the informed consent
- •BMI ≥95th percentile at screening (on sex- and age-specific BMI growth charts (CDC.gov))
- •Body weight >60 kg at screening
排除标准
- •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: - Liposuction and/or abdominoplasty, if performed >1 year prior to screening - Adjustable gastric banding, if the band has been removed >1 year prior to screening - Intragastric balloon, if the balloon has been removed >1 year prior to screening - Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year prior to screening
- •Endocrine, hypothalamic, or syndromic obesity
- •History of type 1 or type 2 diabetes mellitus (as declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records).
结局指标
主要结局
Maintenance of BMI below obesity threshold. From 1.5 years to 3 years. Count of participant.
Maintenance of BMI below obesity threshold. From 1.5 years to 3 years. Count of participant.
次要结局
- Maintenance of improved BMI category. From 1.5 years to 3 years and end of continued treatment phase (up to 6 years). Count of participant.
- Tapering to zero dose. From 1.5 years to 3 years. Count of participant.
- Time/dose steps before ending dose tapering. From 1.5 years to 3 years. Weeks, count of dose steps.
- Achieving BMI below obesity threshold. From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years). Count of participant.
- Achieving any improvement in BMI category. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Count of participant.
- Change in BMI. From baseline (day 0) to 1.5 and 3 years. Percent.
- BMI percentage of the 95th percentile. From baseline (day 0) to 1.5 and 3 years. Percent.
- Change in BMI SDS. From baseline (day 0) to 1.5 and 3 years. Unitless.
- Change in waist-to-height ratio (waist [cm]/ height [cm]). From baseline (day 0) to 1.5 and 3 years. Unitless.
- Change in waist circumference. From baseline (day 0) to 1.5 and 3 years. Cm.
- Change in HbA1c. From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years). Percentage points.
- Change in fasting plasma glucose. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). mmol/L, mg/dL.
- Change in fasting insulin and HOMA-IR. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent.
- Change in hsCRP. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent.
- Change in ALT, total cholesterol, HDL, LDL, VLDL and triglycerides. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent.
- Change in systolic and diastolic blood pressure. From baseline (day 0) to 1.5 and 3 years and end of continued treatment phase (up to 6 years). mmHg.
- Change in fat mass, by DXA relative to total body mass. From baseline (day 0) to 1.5 and 3 years. Percentage points.
- Change in lean body mass, by DXA relative to total body mass. From baseline (day 0) to 1.5 and 3 years. Percentage points.
- Relative change in visceral fat mass by DXA. From baseline (day 0) to 1.5 and 3 years. Percent.
- SAEs. 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). Count.
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (36)
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