JPRN-jRCT2080220634未知3 期
A phase 3 confrimatory study of ATL-962
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 210
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
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Key Criteria for inclusion:
- •The subject whose BMI is not less than 25 at the start and the end of the run-in period.
- •The subject whose visceral fat area is not less than 100 cm2 at 8 weeks after the start of the run-in period(-4 Week).
- •The subject who is diagnosed as type 2 diabetes mellitus and the HbA1C values are >= 6.5% and < 10.0% at the start of the run-in period.
- •The subject who diagnosed as dyslipidemia and meet one of the following criteria for the fasting plasma lipid profile at the start of the run-in period:
- •Hyper-LDL cholesterolemia:LDL cholesterol >= 140 mg/dL
- •Hypo-HDL cholesterolemia:HDL cholesterol < 40 mg/dL
- •Hypertriglyceridemia:Triglyceride >= 150 mg/d
排除标准
- •Key Criteria for exclusion:
- •The subject who have received any anti-obesity drugs (Mazindol and/or prescribed herb medicines which are indicated as an anti-obesity drug) within 4 weeks prior to the start of the run-in period
研究者
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