EUCTR2008-001049-24-IT进行中(未招募)不适用
Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with co-morbiditiesA randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either one or three years of treatment based on pre-diabetes status at randomisation - eliot
OVO NORDISK0 个研究点目标入组 4,800 人开始时间: 2008年10月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 4,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Informed consent obtained before any trial-related activities (Trial related activities are any procedure that would not have been performed during the normal management of the subject)
- •2.Body Mass Index (BMI) 30.0 kg/m2 or 27 kg/m2 in the presence of co-morbidities (treated or untreated hypertension or dyslipidaemia according to ATP-III)
- •3.Stable body weight (less than 5 kg self-reported change during the previous 3 months)
- •4.Preceding failed dietary effort
- •5.Age ≥ 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Diagnosis of type 1 or type 2 diabetes per the judgement of the Investigator
- •HbA1c ≥ 7 % at Visit 1
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Obesity induced by drug treatment
- •Use of approved weight lowering pharmacotherapy
- •Previous surgical treatment of obesity
- •History of major depressive desorder or suicide attempt
- •Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
研究者
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