Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow-up Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0
研究概览
简要总结
This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).
Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).
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
- •Body Mass Index (BMI) of either 30 kg/m^2 or more or BMI of less than 30 kg/m^2 to 27 kg/m^2 with presence of co-morbidities
- •Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
- •Previously undergone dietary weight loss and was not able to maintain reduced weight
排除标准
- •Diagnosis of type 1 or type 2 diabetes
- •Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months
- •Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
- •Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
- •Current participation in an organized diet reduction program (or within the last 3 months)
- •Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin
- •Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
- •History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder
- •Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial
研究组 & 干预措施
Lira 3.0 mg
A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
干预措施: liraglutide (Drug)
Placebo
A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0
时间窗: Week 0, week 56
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Mean Percentage Change in Fasting Body Weight From Baseline
时间窗: Week 0, week 56
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0
时间窗: Week 0, week 56
Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
次要结局
- Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0(Week 0, week 56)
- Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0(Week 0, week 56)
- Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0(Week 0, week 56)
- Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0(Week 0, week 56)
- Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0(Week 0, week 56)
- Change From Baseline in Fasting Weight(Week 0, week 56)
- Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period(Week 0, week 68)
- Change From Baseline in Blood Pressure(Week 0, week 56)
- Change From Baseline in Pulse(Week 0, week 56)
- Change From Baseline in Fasting Lipid Profile: Triglycerides(Week 0, week 56)
- Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol(Week 0, week 56)
- Change From Baseline in Fasting Lipid Profile: Total Cholesterol(Week 0, week 56)
- Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)(Week 0, week 56)
- Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56(Week 56)
- Change From Baseline in Waist Circumference(Week 0, week 56)
- Change From Baseline in Body Mass Index (BMI)(Week 0, week 56)
- Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)(Week 0, week 56)
- Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)(Week 0, week 56)
- Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)(Week 0, week 56)
- Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin(Week 0, week 56)
- Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)(Week 0, week 56)
- Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)(Week 0 and week 56)
- Binge Eating Scale Scores by Week and Severity(Week 0, week 50 and week 57)