A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-ARM, PARALLEL METHODOLOGY STUDY TO ASSESS THE EFFECT OF LIRAGLUTIDE ON FOOD INTAKE IN OBESE SUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5
研究概览
简要总结
This will be a randomized, double blind, placebo controlled, 2 arm, parallel group, methodology study to assess the effect of 6 weeks of liraglutide administration on food intake in obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and female subjects;
- •Body Mass Index 30-40 kg/m2;
排除标准
- •Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
研究组 & 干预措施
Active
Liraglutide
干预措施: Liraglutide (Drug)
Placebo
Placebo comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5
时间窗: Visit 3, Visit 4 and Visit 5
The mean energy intake was collected to assess the effect of liraglutide on food intake in non-diabetic, obese participants. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Mean energy intakes at Visit 4 was defined as the mean values of the measurements at Study Day 20 and 21. Same definition applies to Visit 5 (Study Day 41 and 42). Baseline was defined as the mean of Visit 3 (Study Day -1 and 0).
次要结局
- Number of Participants With Vital Signs Data Meeting Categorical Criteria(Baseline (Visit 3) up to Visit 6 (Study Day 53))
- Number of Participants With Treatment-Emergent Adverse Events (All-Causality)(Baseline (Visit 3) up to 31 days post last dose (75 days))
- Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)(Baseline (Visit 3) up to Visit 6 (Study Day 53))
- Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)(Baseline (Visit 3) up to Visit 6 (Study Day 53))
- Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5(Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42))
- Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5(Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42))
- Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5(Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42))
- Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5(Prior to breakfast and at 30,60,90,120,180 and 300 minutes after intake of the acetaminophen with breakfast on Visit 3,Visit 4 (Study Day 20) and Visit 5 (Study Day 41))