Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Solvay Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to learn if BMS-646256 can cause weight loss in men and women who are:
The safety of this treatment will also be studied
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T | Experimental | 5 mg (ST) to 50 mg (LT) |
|
| U | Experimental | 10 mg (ST) to 50 mg (LT) |
|
| V | Experimental | 25 mg (ST) to 50 mg (LT) |
|
| W | Experimental | 50 mg (ST and LT) |
|
| X | Experimental | 25 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT) |
|
| Z | Experimental | Open label: 50 mg/d (X 4 wks) 100 mg/wk (X8 wks) (ST) to 50 mg (LT) Once daily (x 4 weeks), once daily (x 8 weeks) |
|
| Y |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-646256 | Drug | Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight from the start of the study | Average of Week 11 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Average of Week 11 and 12 | |
| BMI | Change from baseline to Week 12, Week 32, and Week 44 | |
| waist circumference |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ucla Center For Human Nutrition | Los Angeles | California | 90095 | United States | ||
| Domenica M. Rubino, Md |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Comparator |
0 mg (ST and LT) |
|
| Placebo | Drug | Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT) |
|
| Change from baseline to Week 12, Week 32, and Week 44 |
| hormonal measures of insulin sensitivity and safety | Percent change from baseline to Week 12, Week 32, and Week 44 |
| blood pressure | Change from baseline to Week 12, Week 32, and Week 44 |
| blood lipids | Change from baseline to Week 12, Week 32, and Week 44 |
| incidence of adverse events and lab abnormalities | throughout the study |
| Change and percent change in body weight | at Week 32 from baseline and Week 12 |
| Time-matched change from baseline in QTc | at Week 12 and Week 32 |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| Csra Partners In Health, Inc | Augusta | Georgia | 30909 | United States |
| Springfield Diabetes And Endocrine Center | Springfield | Illinois | 62704 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| The Center For Nutrition & Preventive Medicine, Pllc | Charlotte | North Carolina | 28211 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Medical University Of South Carolina | Charleston | South Carolina | 29425 | United States |
| Hampton Roads Center For Clinical Research Inc. | Norfolk | Virginia | 23502 | United States |
| National Clinical Research, Inc. | Richmond | Virginia | 23294 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided