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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00388609
• Other study ID #: MB109-007
• Status: Terminated
• Phase: Phase 2
• First received: October 5, 2006
• Last updated: September 15, 2010
• Start date: November 2006
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 705
• Est. completion date: April 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• BMS-646256
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
• Placebo
Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in body weight from the start of the study		Average of Week 11 and 12	No
Secondary	Change in body weight		Average of Week 11 and 12	No
Secondary	BMI		Change from baseline to Week 12, Week 32, and Week 44	No
Secondary	waist circumference		Change from baseline to Week 12, Week 32, and Week 44	No
Secondary	hormonal measures of insulin sensitivity and safety		Percent change from baseline to Week 12, Week 32, and Week 44	No
Secondary	blood pressure		Change from baseline to Week 12, Week 32, and Week 44	No
Secondary	blood lipids		Change from baseline to Week 12, Week 32, and Week 44	No
Secondary	incidence of adverse events and lab abnormalities		throughout the study	Yes
Secondary	Change and percent change in body weight		at Week 32 from baseline and Week 12	No
Secondary	Time-matched change from baseline in QTc		at Week 12 and Week 32	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm