ObesityPhase 2NCT00388609
Multiple-dose Study to Evaluate the Efficacy, Safety and Pharmacokinetics of BMS-646256 in Obese Subjects
A Phase 2 study testing BMS-646256 in people with Obesity, run by Bristol-Myers Squibb at 10 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- BMS-646256
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 705 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2006to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Csra Partners In Health, Inc
Augusta, Georgia, 30909
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Medical University Of South Carolina
Charleston, South Carolina, 29425
The Center For Nutrition & Preventive Medicine, Pllc
Charlotte, North Carolina, 28211
Duke University Medical Center
Durham, North Carolina, 27710
Ucla Center For Human Nutrition
Los Angeles, California, 90095
Hampton Roads Center For Clinical Research Inc.
Norfolk, Virginia, 23502
National Clinical Research, Inc.
Richmond, Virginia, 23294
Springfield Diabetes And Endocrine Center
Springfield, Illinois, 62704
Domenica M. Rubino, Md
Washington D.C., District of Columbia, 20037
About this study
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
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
- Conditions
- Obesity
- Being tested
- BMS-646256, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-646256Drug
Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
PlaceboDrug
Tablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT)
| Study group | Role | What they receive |
|---|---|---|
| T | Experimental | 5 mg (ST) to 50 mg (LT) Receives: Drug: BMS-646256 |
| U | Experimental | 10 mg (ST) to 50 mg (LT) Receives: Drug: BMS-646256 |
| V | Experimental | 25 mg (ST) to 50 mg (LT) Receives: Drug: BMS-646256 |
| W | Experimental | 50 mg (ST and LT) Receives: Drug: BMS-646256 |
| X | Experimental | 25 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT) Receives: Drug: BMS-646256 |
| Z | Experimental | 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) Receives: Drug: BMS-646256 |
| Y | Placebo comparator | 0 mg (ST and LT) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from the start of the study
Measured: Average of Week 11 and 12
Secondary outcomes (9)
Change in body weight
Measured: Average of Week 11 and 12
BMI
Measured: Change from baseline to Week 12, Week 32, and Week 44
waist circumference
Measured: Change from baseline to Week 12, Week 32, and Week 44
hormonal measures of insulin sensitivity and safety
Measured: Percent change from baseline to Week 12, Week 32, and Week 44
blood pressure
Measured: Change from baseline to Week 12, Week 32, and Week 44
blood lipids
Measured: Change from baseline to Week 12, Week 32, and Week 44
incidence of adverse events and lab abnormalities
Measured: throughout the study
Change and percent change in body weight
Measured: at Week 32 from baseline and Week 12
Time-matched change from baseline in QTc
Measured: at Week 12 and Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388609
- Sponsor's protocol ID
- MB109-007
- Status last verified
- May 2009
- First submitted
- 5 Oct 2006
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00388609
- Acronym / sponsor ID
- MB109-007
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| T | Experimental | Drug: BMS-6462565 mg (ST) to 50 mg (LT) |
| U | Experimental | Drug: BMS-64625610 mg (ST) to 50 mg (LT) |
| V | Experimental | Drug: BMS-64625625 mg (ST) to 50 mg (LT) |
| W | Experimental | Drug: BMS-64625650 mg (ST and LT) |
| X | Experimental | Drug: BMS-64625625 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT) |
| Z | Experimental | Drug: BMS-646256Open 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 comparator | Drug: Placebo0 mg (ST and LT) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-646256Tablet, Oral, Once Daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT) | Drug | T, U, V, W, X, Z |
| PlaceboTablet, Oral, Once daily, 12 weeks treatment followed by 20 week washout (ST); up to 190 weeks treatment (LT) | Drug | Y |
Primary outcome
Percent change in body weight from the start of the study
Time frame: Average of Week 11 and 12
9 secondary outcomes
Change in body weight
Time frame: Average of Week 11 and 12
BMI
Time frame: Change from baseline to Week 12, Week 32, and Week 44
waist circumference
Time frame: Change from baseline to Week 12, Week 32, and Week 44
hormonal measures of insulin sensitivity and safety
Time frame: Percent change from baseline to Week 12, Week 32, and Week 44
blood pressure
Time frame: Change from baseline to Week 12, Week 32, and Week 44
blood lipids
Time frame: Change from baseline to Week 12, Week 32, and Week 44
incidence of adverse events and lab abnormalities
Time frame: throughout the study
Change and percent change in body weight
Time frame: at Week 32 from baseline and Week 12
Time-matched change from baseline in QTc
Time frame: at Week 12 and Week 32
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-646256 in people with Obesity, run by Bristol-Myers Squibb at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight from the start of the study (time frame: Average of Week 11 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2010.