EUCTR2008-001049-24-GB进行中（未招募）不适用
Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either 56 or 160 weeks of treatment based on pre-diabetes status at randomisation - SCALE™ – Obesity and Pre-diabetes
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,600
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
- •Informed consent obtained
- •Body Mass Index (BMI) = 30.0 kg/m2 or = 27 kg/m2 in the presence of co-morbidities (treated or untreated hypertension or dyslipidaemia)
- •Stable body weight
- •Preceding failed dietary effort
- •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
- •Known type 1 or type 2 diabetes
- •HbA1c = 6.5 % (Screening visit 1) or FPG = 126 mg/dL (7 mmol/L) (Screening visit 2) or 2 hr post-challenge (OGTT) plasma glucose =200 mg/dL (11.1 mmol/L) (Screening visit 2)
- •Screening calcitonin = 50 ng/L
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- •Personal history of non-familial medullary thyroid carcinoma
- •History of acute or chronic pancreatitis
- •Obesity induced by drug treatment
- •Use of approved weight lowering pharmacotherapy
- •Previous surgical treatment of obesity
- •History of major depressive disorder or suicide attempt
研究者
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