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临床试验/NCT02918279
NCT02918279已完成3 期

Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2016年9月29日最近更新:
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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
251
试验地点
1
主要终点
Change in BMI SDS (Week 0, Week 56)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.

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)

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 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, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation
  • •BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
  • •Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change)
  • •History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record

排除标准

  • •Pre-pubertal subjects (Tanner stage 1) at screening V2
  • •Type 1 diabetes mellitus (T1DM)
  • •Family or personal history of multiple endocrine neoplasia type 2 (MEN2)
  • •Medullary thyroid carcinoma (MTC)
  • •History of pancreatitis (acute or chronic)
  • •Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)
  • •Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)
  • •Anti-diabetic treatment other than metformin
  • •History of major depressive disorder within 2 years before screening V2

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

Liraglutide

Experimental

干预措施: Liraglutide (Drug)

结局指标

主要结局

Change in BMI SDS (Week 0, Week 56)

时间窗: Week 0, week 56

Change from baseline (week 0) in BMI SDS was evaluated at week 56. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56.

次要结局

  • Change in Waist-to-hip Circumference Ratio((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Fasting Lipid: Triglycerides (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))((Week 0, week 30); (Week 0, week 82); (Week 56, week 82))
  • Change in BMI((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Body Weight (lb)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Waist Circumference((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Percent of Subjects Achieving ≥10% Reduction in Baseline BMI(Weeks 30, 56 and 82)
  • Change in hsCRP((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in FPG((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Percent of Subjects Achieving ≥5% Reduction in Baseline BMI(Weeks 30, 56 and 82)
  • Change in Body Weight (kg)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Fasting C-peptide (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Glycaemic Category(Week -2, week 30, week 56 and week 82)
  • Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)(Week 0-56 + 14 days)
  • Change in Haematology: Haemoglobin((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Haematology: Haematocrit((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Haematology: Erythrocytes((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Body Weight (%)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in HOMA-IR (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in IWQOL-Kids((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Nutritional Compliance(Week 0, week 30 and week 56)
  • Number of Treatment Emergent Adverse Events(Week 0-56 + 14 days)
  • Change in Fasting Lipid: FFA (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Systolic and Diastolic Blood Pressure((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in HbA1c((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Fasting Insulin (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)(Week 0-56 + 14 days)
  • Change in Biochemistry: Creatinine and Bilirubin (Total)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in HOMA-B (Ratio to Baseline)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Occurrence of Anti-liraglutide Antibodies(Weeks 0, 30, 56, 58, 70 and 82)
  • Change in Biochemistry: CEA((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in C-SSRS((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in BMI SDS (%)((Week 0, week 30); (Week 0, week 56))
  • Change in Pulse((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in ECG(Week -14, week 30, week 56 and week 82)
  • Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Biochemistry: Albumin((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Hormone Level: Calcitonin((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Hormone Level: TSH and Prolactin((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Hormone Level: DHEAS((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Hormone Level: Estradiol (Females)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in NTX1((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in CTX1((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in P1NP((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Hormone Level: Free T4 and ACTH((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Height SDS((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Hormone Level: IGF-1 and Cortisol((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Hormone Level: LH and FSH((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Alkaline Phosphatase (Bone)((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Pubertal Status((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))
  • Change in Hormone Level: Testosterone (Males)(Week 0, week 30, week 56 and week 82)
  • Change in Physical Examination(Week 0, week 30, week 56 and week 82)
  • Change in PHQ-9((Week 0, week 30); (Week 0, week 56); (Week 56, week 82))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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