NCT02717858已完成1 期
A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Maximum postprandial gallbladder ejection fraction (GBEFmax)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the effects of liraglutide on gallbladder emptying in overweight and 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
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) equal to or above 27.0 kg/m^2
- •Stable body weight (less than 3 kg self-reported change during the previous 3 months)
- •Ultrasound assessment of gallbladder volume of an acceptable quality at screening, as judged by the investigator
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or longacting injections))
- •History of gastrointestinal surgery or other medical procedure precluding gallbladder emptying assessment (appendectomy is allowed) or any significant digestive disease per the judgement of the investigator
- •History of pancreatitis (acute or chronic) or any gallbladder disease (incl. gallstones, gallbladder sludge, or polyps)
- •Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
研究组 & 干预措施
Liraglutide
Experimental
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Maximum postprandial gallbladder ejection fraction (GBEFmax)
时间窗: At 12 weeks (visit 9)
次要结局
- GBEFmax (maximum gallbladder ejection fraction) after first treatment dose(At first treatment dose (visit 4, day 2))
- Gallbladder volume(At 12 weeks (visit 9))
- Area under gallbladder EF-time (ejection fraction) curve(At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85))
- Area under gallbladder EF-time curve(At 12 weeks (visit 9))
- Area under the paracetamol concentration-time curve(At 12 weeks (visit 9))
- Incremental area under the plasma glucose concentration-time curve(At 12 weeks (visit 9))
研究者
研究点 (1)
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