NCT00500370已完成2 期
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Have a Body Mass Index (BMI) >= 30kg/m^2
排除标准
- •Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
- •Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
- •Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for > 3 months
- •Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
- •Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
- •Are actively participating in, or have participated in a formal weight loss program within the last 3 months
- •Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
- •Have been treated with any anti-diabetic medications within 3 months of screening
- •Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
- •Have had bariatric surgery
- •Have had an organ transplant
研究组 & 干预措施
Group A
Experimental
干预措施: exenatide (Drug)
Group B
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in Body Weight
时间窗: 24 weeks
Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)
次要结局
- Change in Low Density Lipoprotein (LDL) Cholesterol(24 weeks)
- Change in Fasting Serum Glucose(24 weeks)
- Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)(24 weeks)
- Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)(24 weeks)
- Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)(24 weeks)
- Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis(24 weeks)
- Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)(24 weeks)
- Change in High Sensitivity C-reactive Protein (hsCRP)(24 weeks)
- Change in Glycosylated Hemoglobin (HbA1c)(24 weeks)
- Percentage of Patients Experiencing >=5% Weight Loss(24 weeks)
- Change in Total Cholesterol(24 weeks)
- Change in High Density Lipoprotein (HDL) Cholesterol(24 weeks)
- Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)(24 weeks)
- Change in Body Mass Index (BMI)(24 weeks)
- Change in Waist-to-hip Ratio(24 weeks)
研究者
研究点 (1)
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