Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,731
- 试验地点
- 1
- 主要终点
- Change From Baseline in Fasting Body Weight
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.
The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.
Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained
- •Body Mass Index (BMI) of 30.0 kg/m^2 or above
- •Body Mass Index (BMI) of 27 kg/m^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension
- •Stable body weight
- •Preceding failed dietary effort
排除标准
- •Known type 1 or type 2 diabetes
- •Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)
- •Screening calcitonin of 50 ng/L or above
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- •Personal history of non-familial medullary thyroid carcinoma
- •History of acute or chronic pancreatitis
- •Obesity induced by drug treatment
- •Use of approved weight lowering pharmacotherapy
- •Previous surgical treatment of obesity
- •History of major depressive disorder or suicide attempt
- •Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
研究组 & 干预措施
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
干预措施: placebo (Drug)
Liraglutide Placebo, no Pre-diabetes
干预措施: placebo (Drug)
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
干预措施: liraglutide (Drug)
Liraglutide 3.0mg, Pre-diabetes
干预措施: liraglutide (Drug)
Liraglutide Placebo, Pre-diabetes
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Fasting Body Weight
时间窗: Week 0, Week 56
The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
时间窗: At Week 56
Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight
时间窗: At 56 weeks
Percentage of subjects losing \>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Proportion of Subjects With Onset of Type 2 Diabetes
时间窗: At 160 weeks
Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
次要结局
- Change From Baseline in Waist Circumference (cm)(Week 0, Week 56)
- Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)(Week 0, week 160)
- Pre-diabetes Status After 56 Weeks of Treatment(Week 0, Week 56)
- Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment(Week 0, week 160)
- Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)(Week 0, week 160)
- Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)(At 160 weeks)
- Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)(Week 56, Week 68)
- Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)(Week 0, Week 68)