NCT00978393已完成1 期
A Randomised, Placebo-controlled, Double-blind, Incomplete Cross-over Design Trial to Evaluate the Effects of Liraglutide on Gastric Emptying, Energy Expenditure and Appetite, and to Evaluate Liraglutide Pharmacokinetics in Non-diabetic 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
- 49
- 试验地点
- 1
- 主要终点
- Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate the effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a two-period, six-sequenced, crossover trial where the trial participant will enter two treatment periods with a wash-out period of 6-8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Body Mass Index (BMI) between 30.0-40.0 kg/m2
- •Stable body weight (below 5 kg body weight change during past 3 month)
- •Fasting plasma glucose below 7.0 mmol/L
排除标准
- •Presence or history of cancer or any clinically significant cardiac, metabolic, renal, gastrointestinal, hepatic, endocrine, dermatological, haematological, or psychiatric diseases or disorders, considered by the Investigator to have influence of the results of this trial
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Current or history of treatment with medications that may cause significant weight gain, within 12 months prior to screening
- •Use of weight lowering pharmacotherapy within the last 3 months prior to trial start
- •Previous or scheduled (during the trial period) surgical treatment for obesity
- •Diagnosed type 1 or type 2 diabetes
- •Smoking habitually as judged by the Investigator
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods if not sterile or post-menopausal
研究组 & 干预措施
A
Experimental
干预措施: liraglutide (Drug)
B
Experimental
干预措施: liraglutide (Drug)
C
Experimental
干预措施: liraglutide (Drug)
D
Experimental
干预措施: liraglutide (Drug)
E
Experimental
干预措施: liraglutide (Drug)
F
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol
时间窗: after 35 days of treatment
次要结局
- Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles(after 35 days of treatment)
研究者
研究点 (1)
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