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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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

Key facts

Study ID

NCT00388609

Run by

Bristol-Myers Squibb

People needed

705

Starts

2006-11-01

Expected to finish

2009-04-01

Last updated by the study team

2010-09-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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