Multiple-dose Study to Evaluate the Efficacy, Safety and Pharmacokinetics of BMS-646256 in Obese Subjects
This study has been terminated.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00388609
First received: October 5, 2006
Last updated: September 15, 2010
Last verified: May 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: BMS-646256 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
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: | April 2009 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 | |
| The Center For Nutrition & Preventive Medicine, Pllc | |
| Charlotte, North Carolina, United States, 28211 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, South Carolina | |
| Medical University Of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Virginia | |
| Hampton Roads Center For Clinical Research Inc. | |
| Norfolk, Virginia, United States, 23502 | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00388609 History of Changes |
| Other Study ID Numbers: | MB109-007 |
| Study First Received: | October 5, 2006 |
| Last Updated: | September 15, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013