Multiple-dose Study to Evaluate the Efficacy, Safety and Pharmacokinetics of BMS-646256 in Obese Subjects
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
1 other identifier
interventional
705
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Nov 2006
Typical duration for phase_2 obesity
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2006
CompletedFirst Posted
Study publicly available on registry
October 17, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedSeptember 17, 2010
May 1, 2009
10 months
October 5, 2006
September 15, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in body weight from the start of the study
Average of Week 11 and 12
Secondary Outcomes (9)
Change in body weight
Average of Week 11 and 12
BMI
Change from baseline to Week 12, Week 32, and Week 44
waist circumference
Change from baseline to Week 12, Week 32, and Week 44
hormonal measures of insulin sensitivity and safety
Percent change from baseline to Week 12, Week 32, and Week 44
blood pressure
Change from baseline to Week 12, Week 32, and Week 44
- +4 more secondary outcomes
Study Arms (7)
T
EXPERIMENTAL5 mg (ST) to 50 mg (LT)
U
EXPERIMENTAL10 mg (ST) to 50 mg (LT)
V
EXPERIMENTAL25 mg (ST) to 50 mg (LT)
W
EXPERIMENTAL50 mg (ST and LT)
X
EXPERIMENTAL25 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT)
Z
EXPERIMENTALOpen 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)
Y
PLACEBO COMPARATOR0 mg (ST and LT)
Interventions
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Solvay Pharmaceuticalscollaborator
Study Sites (10)
Ucla Center For Human Nutrition
Los Angeles, California, 90095, United States
Domenica M. Rubino, Md
Washington D.C., District of Columbia, 20037, United States
Csra Partners In Health, Inc
Augusta, Georgia, 30909, United States
Springfield Diabetes And Endocrine Center
Springfield, Illinois, 62704, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
The Center For Nutrition & Preventive Medicine, Pllc
Charlotte, North Carolina, 28211, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Medical University Of South Carolina
Charleston, South Carolina, 29425, United States
Hampton Roads Center For Clinical Research Inc.
Norfolk, Virginia, 23502, United States
National Clinical Research, Inc.
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2006
First Posted
October 17, 2006
Study Start
November 1, 2006
Primary Completion
September 1, 2007
Study Completion
April 1, 2009
Last Updated
September 17, 2010
Record last verified: 2009-05