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

Phase 2

Terminated

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
T	BMS-646256	5 mg (ST) to 50 mg (LT)
Y	Placebo	0 mg (ST and LT)
X	BMS-646256	25 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT)
U	BMS-646256	10 mg (ST) to 50 mg (LT)
V	BMS-646256	25 mg (ST) to 50 mg (LT)
W	BMS-646256	50 mg (ST and LT)
Z	BMS-646256	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)

Primary Outcome Measures

Name	Time	Method
Percent change in body weight from the start of the study	Average of Week 11 and 12

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Average of Week 11 and 12
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
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

Locations (10): Domenica M. Rubino, Md
🇺🇸
Washington, District of Columbia, United States
Pennington Biomedical Research Center
🇺🇸
Baton Rouge, Louisiana, United States
Springfield Diabetes And Endocrine Center
🇺🇸
Springfield, Illinois, United States
Ucla Center For Human Nutrition
🇺🇸
Los Angeles, California, United States
Csra Partners In Health, Inc
🇺🇸
Augusta, Georgia, United States
The Center For Nutrition & Preventive Medicine, Pllc
🇺🇸
Charlotte, North Carolina, United States
National Clinical Research, Inc.
🇺🇸
Richmond, Virginia, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Hampton Roads Center For Clinical Research Inc.
🇺🇸
Norfolk, Virginia, United States
Medical University Of South Carolina
🇺🇸
Charleston, South Carolina, United States