KCT0001225
Active, not recruiting
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 sites60 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic disease
- Sponsor
- Yuyu Phama
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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