KCT0001225进行中（未招募）未知
The clinical study for the evaluation of the efficacy and safety of YY-312 on reducing body weight and body fat mass of obese Korean. : a 12 weeks, randomized, double-blind, placebo-controlled clinical trial
Yuyu Phama0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •1) Male and female subjects between 19-60years of age inclusive.
- •2) BMI of 25.0 - 30.0kg/m2
- •3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
排除标准
- •1) Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg and also taking a beta blocker or a hydragogue
- •2) Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL
- •3) Subjects with endocrinopathy or abnormal screening TSH(Thyroid-Stimulating Hormone) value(=0.1uU/ml or =10 uU/ml)
- •4) Subjects with hyperlipidemia) (fasting triglycerides > 600mg/dl)
- •5) Serum AST(aminotransferse)/ALT(alanine amintransferse) = 3 times the upper limit of normal
- •6) Serum creatinine = 1.5 times the upper limit of normal
- •7) Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon
- •8) Subjects with taking drugs that can affect the body weight within the 3 months
- •9) Subjects with clinically significant cardiovascular disease within the 6 months prior to screening
- •10) Subjects who change weight more than 4kg within 4 months
- •11) Subjects with pancreatopathy
- •12) Subjects with chronic malabsorption syndrome or bile secretion disorder
- •13) Subjects with undergoing gastrointestinal operation for reducing boy weight
- •14) Subjects with postoperative intestinal adhesion
- •15) Subjects with a history of cancer and intervention within the 5 years prior to screening
- •16) Subjects with a history of CNS(central nervous system) disorder(depressive disorder, schizophrenia, alcoholism, drug addiction)
- •17) Subjects with heart disease, kidney disease, liver disease, lung disease and cerebrovascular disease
- •18) Subjects with gallbladder diseases, gastrointestinal diseases, gout and porphyria
- •19) Subjects with asthma and allergic disease
- •20) Subjects with bulimia and abuse of relievers
- •21) Women of childbearing age who are disagreed with effective contraceptions in the clinical trial period
- •22) Woman who are pregnant or lactating
- •23) Participation in any clinical trial within the 1 month prior to screening.
- •24) Subjects who could affect preclude evaluation of response in the opinion investigator
研究者
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