Multiple-dose Study to Evaluate the Efficacy, Safety and Pharmacokinetics of BMS-646256 in Obese Subjects

A Randomized, Double-blind, Placebo-Controlled, Parallel Arm, Multiple-Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BMS-646256 in Obese and High Risk Overweight Subjects

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

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