The purpose of this study is to learn if BMS-646256 can cause weight loss in men and women who are: * overweight with high blood pressure or high cholesterol or * obese The safety of this treatment will also be studied
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
705
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Ucla Center For Human Nutrition
Los Angeles, California, United States
Domenica M. Rubino, Md
Washington D.C., District of Columbia, United States
Csra Partners In Health, Inc
Augusta, Georgia, United States
Percent change in body weight from the start of the study
Time frame: Average of Week 11 and 12
Change in body weight
Time frame: Average of Week 11 and 12
BMI
Time frame: Change from baseline to Week 12, Week 32, and Week 44
waist circumference
Time frame: Change from baseline to Week 12, Week 32, and Week 44
hormonal measures of insulin sensitivity and safety
Time frame: Percent change from baseline to Week 12, Week 32, and Week 44
blood pressure
Time frame: Change from baseline to Week 12, Week 32, and Week 44
blood lipids
Time frame: Change from baseline to Week 12, Week 32, and Week 44
incidence of adverse events and lab abnormalities
Time frame: throughout the study
Change and percent change in body weight
Time frame: at Week 32 from baseline and Week 12
Time-matched change from baseline in QTc
Time frame: at Week 12 and Week 32
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Springfield Diabetes And Endocrine Center
Springfield, Illinois, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
The Center For Nutrition & Preventive Medicine, Pllc
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Hampton Roads Center For Clinical Research Inc.
Norfolk, Virginia, United States
National Clinical Research, Inc.
Richmond, Virginia, United States