Obesity
Conditions
Brief summary
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
Interventions
DRUGBMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
DRUGPlacebo
Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Sponsors
Solvay Pharmaceuticals
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Men and women, ages ≥18 to ≤70 years old with a Body Mass Index (BMI) ≥30 to ≤45 kg/m² OR BMI \>27 to \<30 kg/m² with hypertension and/or dyslipidemia defined as: * Hypertension defined as treatment with an antihypertensive agent or mean systolic blood pressure ≥140 and ≤160 mmHg and/or diastolic blood pressure ≥ 90 and ≤ 105 mmHg * Dyslipidemia defined as stable dose treatment with a statin, fibrate or ezetimibe for ≥ 6 weeks and/or triglycerides ≥ 150 and ≤ 600 mg/dL, LDL ≥ 130 and ≤ 300 mg/dL, or HDL \< 40 mg/dL
Exclusion criteria
* Type 1 or 2 diabetes mellitus * history of MI in the prior 6 months * history of heart failure * history of symptomatic arrhythmia * active hepatic disease * any documented muscle disease * history of neurological symptoms or disease (including but not limited to tremor, ataxia, dizziness, neuropathy, or episodes of confusion, history of seizures, stroke or TIA) * known history of major psychiatric conditions (e.g. schizophrenia anxiety disorder, dementia or bipolar disorder as defined by DSM IV criteria) * history of depression or suicide attempt or ideation * previous history of surgical procedures for weight loss (e.g., stomach stapling, bypass) * uncontrolled blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight from the start of the study | Average of Week 11 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| BMI | Change from baseline to Week 12, Week 32, and Week 44 |
| waist circumference | 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 |
| Change in body weight | Average of Week 11 and 12 |
| 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 |
| blood lipids | Change from baseline to Week 12, Week 32, and Week 44 |
Countries
United States
Outcome results
None listed