Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 564
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Body Weight at Week 20
研究概览
简要总结
This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.
Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2
- •Stable body weight (less than 5% selfreported change within the last 3 months)
排除标准
- •Obesity induced by drug treatment
- •Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial
- •Type 1 or type 2 diabetes
研究组 & 干预措施
Lira placebo/Lira 2.4 mg/Lira 3.0 mg
Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
干预措施: placebo (Drug)
Lira 1.2 mg/Lira 3.0 mg
Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
干预措施: liraglutide (Drug)
Lira 1.8 mg/Lira 3.0 mg
Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
干预措施: liraglutide (Drug)
Lira 2.4 mg/Lira 3.0 mg
Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
干预措施: liraglutide (Drug)
Liraglutide 3.0 mg
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
干预措施: liraglutide (Drug)
Liraglutide 3.0 mg
Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
干预措施: placebo (Drug)
Orlistat
Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
干预措施: orlistat (Drug)
结局指标
主要结局
Mean Change From Baseline in Body Weight at Week 20
时间窗: Week 0, week 20
Calculated as mean body weight at week 20 - baseline
次要结局
- Change From Baseline in Fasting Plasma Glucose at Week 104(Week 0, week 104)
- Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20(Week 0, week 20)
- Change From Baseline in Fibrinogen at Week 104(Week 0, week 104)
- Change From Baseline in Waist Circumference at Week 104(Week 0, week 104)
- Change From Baseline in Fasting Plasma Glucose at Week 20(Week 0, week 20)
- Change From Baseline in Fasting Insulin at Week 20(Week 0, week 20)
- Change From Baseline in Fasting Insulin at Week 104(Week 0, week 104)
- Change From Baseline in Adiponectin at Week 20(Week 0, week 20)
- Change From Baseline in Adiponectin at Week 104(Week 0, week 104)
- Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20(Week 0, week 20)
- Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104(Week 0, week 104)
- Change From Baseline in Blood Pressure at Week 20(Week 0, week 20)
- Change From Baseline in Blood Pressure at Week 104(Week 0, week 104)
- Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20(Week 0, week 20)
- Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104(Week 0, week 104)
- Change From Baseline in Waist Circumference at Week 20(Week 0, week 20)
- Mean Change From Baseline in Body Weight at Week 104(Week 0, week 104)
- Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104(Week 0, week 104)
- Change From Baseline in Fibrinogen at Week 20(Week 0, week 20)