CTRI/2011/12/002199已完成3 期
Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: 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 - NI
ovo Nordisk AS0 个研究点目标入组 86 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Informed consent obtained
- •Body Mass Index (BMI) of 30.0 kg/m2 or above
- •Body Mass Index (BMI) of 27 kg/m2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension
- •Stable body weight
- •Preceding failed dietary effort
- •Note-this trial has no upper age limit
排除标准
- •Known type 1 or type 2 diabetes
- •Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)
- •Screening calcitonin of 50 ng/L or above
- •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
- •Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
研究者
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