MedPath

Efficacy and safety of DW2010 on reducing body weight and body fat in overweight subjects; Clinical Trial

Not Applicable
Recruiting
Conditions
Endocrine, nutritional and metabolic disease
Registration Number
KCT0003222
Lead Sponsor
Dongwha Pharmaceutical
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
150
Inclusion Criteria

1) subjects between 20-50years of age inclusive with no menopause
2) BMI of 25.0-29.9kg/m2
3) no drink alcohol at least 1 month and during Clinical Trial
4) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.

Exclusion Criteria

1)The Patients with severe cerebrovascular disease, cardiac disease (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator) within recent 6 months.
2)Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg and also taking a beta blocker or a hydragogue.
3)Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL.
4)Woman who are pregnant of lactating or planning to pregnant
5)Subjects which in the opinion investigator could affect preclude evluation of response

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fat mass(by Dual Energy X-Ray Absorptiometry, DEXA)
Secondary Outcome Measures
NameTimeMethod
Chainge in fat percentage(by Dual Energy X-Ray Absorptiometry, DEXA);Fat Free Mass(by Dual Energy X-Ray Absorptiometry, DEXA);Body mass index(BMI)
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