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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00388609
• Collaborator: Solvay Pharmaceuticals (Industry)
• Enrollment: 705
• Locations: 10
• Arms: 7
• Duration (Months): 29
• Patients Per Site: 70.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: BMS-646256; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 705 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T 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)
Experimental: U 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)
Experimental: V 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)
Experimental: W 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)
Experimental: X 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)
Experimental: Z 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)
Placebo Comparator: Y 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)

Outcome Measures

Primary Outcome Measures

1. Percent change in body weight from the start of the study [Average of Week 11 and 12]

Secondary Outcome Measures

1. Change in body weight [Average of Week 11 and 12]

2. BMI [Change from baseline to Week 12, Week 32, and Week 44]

3. waist circumference [Change from baseline to Week 12, Week 32, and Week 44]

4. hormonal measures of insulin sensitivity and safety [Percent change from baseline to Week 12, Week 32, and Week 44]

5. blood pressure [Change from baseline to Week 12, Week 32, and Week 44]

6. blood lipids [Change from baseline to Week 12, Week 32, and Week 44]

7. incidence of adverse events and lab abnormalities [throughout the study]

8. Change and percent change in body weight [at Week 32 from baseline and Week 12]

9. Time-matched change from baseline in QTc [at Week 12 and Week 32]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Ucla Center For Human Nutrition	Los Angeles	California	United States	90095
2	Domenica M. Rubino, Md	Washington	District of Columbia	United States	20037
3	Csra Partners In Health, Inc	Augusta	Georgia	United States	30909
4	Springfield Diabetes And Endocrine Center	Springfield	Illinois	United States	62704
5	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808
6	The Center For Nutrition & Preventive Medicine, Pllc	Charlotte	North Carolina	United States	28211
7	Duke University Medical Center	Durham	North Carolina	United States	27710
8	Medical University Of South Carolina	Charleston	South Carolina	United States	29425
9	Hampton Roads Center For Clinical Research Inc.	Norfolk	Virginia	United States	23502
10	National Clinical Research, Inc.	Richmond	Virginia	United States	23294

Sponsors and Collaborators

• Bristol-Myers Squibb
• Solvay Pharmaceuticals

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00388609
• Other Study ID Numbers: MB109-007
• First Posted: Oct 17, 2006
• Last Update Posted: Sep 17, 2010
• Last Verified: May 1, 2009

Study Results

No Results Posted as of Sep 17, 2010