EUCTR2020-002939-29-FI进行中（未招募）1 期
Efficacy and safety of subcutaneous semaglutide 2.4 mg once-weekly in subjects with obesity and prediabetes - STEP 10
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 201
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
- •- Male or female aged above or equal to 18 years at the time of signing informed consent.
- •- BMI greater than or equal to 30.0 kg/m^2
- •- Prediabetes defined as at least one of the following:
- •a) HbA1c between 6.0 and 6.4 % (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening.
- •b) FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.
- •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 185
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •- History of type 1 or type 2 diabetes.
- •- Treatment with glucose-lowering agent(s) within 90 days before screening.
- •- HbA1c greater than or equal to 6.5 % (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening.
- •- FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening.
- •- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
- •- Treatment with any medication for the indication of obesity within the past 90 days before screening.
研究者
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