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

This study has been terminated.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014