Multiple-Dose Study to Evaluate the Efficacy, Safety and Pharmacokinetics of BMS-646256 in Obese Subjects - Full Text View

Purpose

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

Condition	Intervention	Phase
Obesity	Drug: BMS-646256 Drug: Placebo	Phase II

MedlinePlus related topics:

Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Percent change in body weight from the start of the study [ Time Frame: Average of Week 11 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in body weight [ Time Frame: Average of Week 11 and 12 ] [ Designated as safety issue: No ]
BMI [ Time Frame: Change from baseline to Week 12, Week 32, and Week 44 ] [ Designated as safety issue: No ]
waist circumference [ Time Frame: Change from baseline to Week 12, Week 32, and Week 44 ] [ Designated as safety issue: No ]
hormonal measures of insulin sensitivity and safety [ Time Frame: Percent change from baseline to Week 12, Week 32, and Week 44 ] [ Designated as safety issue: No ]
blood pressure [ Time Frame: Change from baseline to Week 12, Week 32, and Week 44 ] [ Designated as safety issue: No ]
blood lipids [ Time Frame: Change from baseline to Week 12, Week 32, and Week 44 ] [ Designated as safety issue: No ]
incidence of adverse events and lab abnormalities [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Change and percent change in body weight [ Time Frame: at Week 32 from baseline and Week 12 ] [ Designated as safety issue: No ]
Time-matched change from baseline in QTc [ Time Frame: at Week 12 and Week 32 ] [ Designated as safety issue: No ]

Enrollment:	705
Study Start Date:	November 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
T: Experimental 5 mg (ST) to 50 mg (LT)	Drug: BMS-646256 Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
U: Experimental 10 mg (ST) to 50 mg (LT)	Drug: BMS-646256 Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
V: Experimental 25 mg (ST) to 50 mg (LT)	Drug: BMS-646256 Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
W: Experimental 50 mg (ST and LT)	Drug: BMS-646256 Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
X: Experimental 25 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT)	Drug: BMS-646256 Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (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)	Drug: BMS-646256 Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Y: Placebo Comparator 0 mg (ST and LT)	Drug: Placebo Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388609

Locations


United States, California
	Ucla Center For Human Nutrition
	Los Angeles, California, United States, 90095

United States, District of Columbia
	Domenica M. Rubino, Md
	Washington, District of Columbia, United States, 20037

United States, Georgia
	Csra Partners In Health, Inc
	Augusta, Georgia, United States, 30909

United States, Illinois
	Springfield Diabetes And Endocrine Center
	Springfield, Illinois, United States, 62704

United States, Louisiana
	Pennington Biomedical Research Center
	Baton Rouge, Louisiana, United States, 70808

United States, North Carolina
	Duke University Medical Center
	Durham, North Carolina, United States, 27710
	The Center For Nutrition & Preventive Medicine, Pllc
	Charlotte, North Carolina, United States, 28211

United States, South Carolina
	Medical University Of South Carolina
	Charleston, South Carolina, United States, 29425

United States, Virginia
	National Clinical Research, Inc.
	Richmond, Virginia, United States, 23294
	Hampton Roads Center For Clinical Research Inc.
	Norfolk, Virginia, United States, 23502

Sponsors and Collaborators

Bristol-Myers Squibb

Solvay Pharmaceuticals

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	MB109-007
First Received:	October 5, 2006
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00388609
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overnutrition

Overweight

ClinicalTrials.gov processed this record on September 19, 2008

Sponsors and Collaborators:	Bristol-Myers Squibb Solvay Pharmaceuticals
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00388609