NCT04102189已完成3 期
Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 51
- 主要终点
- Change in Body Mass Index (BMI) (Percentage [%])
研究概览
简要总结
This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.
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
- Double (Participant, Investigator)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of parent(s) or legally acceptable representative of subject and child assent, as appropriate obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Male or female, ages 12 to below 18 years at the time of signing informed consent
- •BMI equal to or above 95th percentile OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes
- •History of at least one self-reported unsuccessful dietary effort to lose weight
- •For subjects with type 2 diabetes at screening the following inclusion criteria apply in addition:
- •- HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening
排除标准
- •Prepubertal subjects (Tanner stage 1)
- •History of type 1 diabetes
- •A self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes)
- •For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. 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
Semaglutide
Experimental
2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly
干预措施: Semaglutide (Drug)
Placebo
Placebo Comparator
Placebo injected s.c. once weekly .
干预措施: Placebo (Other)
结局指标
主要结局
Change in Body Mass Index (BMI) (Percentage [%])
时间窗: Baseline (week 0), week 68
Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
次要结局
- Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)(At week 68)
- Change in Body Weight (Kilograms [kg])(Baseline (week 0), week 68)
- Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)(At week 68)
- Change in Body Weight (%)(Baseline (week 0), week 68)
- Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)(At week 68)
- Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)(At week 68)
- Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])(Baseline (week 0), week 68)
- Percentage of Participants Achieving Improvement in Weight Category (Yes/no)(At week 68)
- Change in Waist Circumference(Baseline (week 0), week 68)
- Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)(At week 68)
- Change in BMI (Standard Deviation Score [SDS])(Baseline (week 0), week 68)
- Change in BMI (Kilograms Per Meter Square [kg/m^2])(Baseline (week 0), week 68)
- Change in Systolic Blood Pressure(Baseline (week 0), week 68)
- Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline(Baseline (week 0), week 68)
- Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline(Baseline (week 0), week 68)
- Change in Total Cholesterol (mmol/L): Ratio to Baseline(Baseline (week 0), week 68)
- Change in Total Cholesterol (mg/dL): Ratio to Baseline(Baseline (week 0), week 68)
- Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline(Baseline (week 0), week 68:)
- Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline(Baseline (week 0), week 68)
- Change in Diastolic Blood Pressure(Baseline (week 0), week 68)
- Change in Glycated Haemoglobin (HbA1c) (%)(Baseline (week 0), week 68)
- Change in HbA1c (Millimoles Per Mole [mmol/Mol])(Baseline (week 0), week 68)
- Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])(Baseline (week 0), week 68)
- Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])(Baseline (week 0), week 68)
- Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline(Baseline (week 0), week 68)
- Change in LDL Cholesterol (mg/dL): Ratio to Baseline(Baseline (week 0), week 68:)
- Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline(Baseline (week 0), week 68)
- Change in VLDL Cholesterol (mg/dL): Ratio to Baseline(Baseline (week 0), week 68)
- Change in Triglycerides (mmol/L): Ratio to Baseline(Baseline (week 0), week 68)
- Change in Triglycerides (mg/dL): Ratio to Baseline(Baseline (week 0), week 68)
- Change in Alanine Aminotransferase (ALT): Ratio to Baseline(Baseline (week 0), week 68)
- Number of Treatment-emergent Adverse Events (TEAEs)(From baseline (week 0) to week 75)
- Number of Treatment-emergent Serious Adverse Events (SAEs)(From baseline (week 0) to week 75)
- Change in Pulse(Baseline (week 0), week 68)
- Change in Amylase: Ratio to Baseline(Baseline (week 0), week 68)
- Change in Lipase: Ratio to Baseline(Baseline (week 0), week 68)
- Change in Calcitonin: Ratio to Baseline(Baseline (week 0), week 68)
研究者
研究点 (51)
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