Clinical trial NCT00388609: Multiple-dose Study to Evaluate the Efficacy, Safety and Pharmacokinetics of BMS-646256 in Obese Subjects
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Solvay Pharmaceuticals
First posted: 2006-10-17
Enrollment: 705
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percent change in body weight from the start of the study
timeFrame: Average of Week 11 and 12
Secondary outcomes:
measure: Change in body weight
timeFrame: Average of Week 11 and 12
measure: BMI
timeFrame: Change from baseline to Week 12, Week 32, and Week 44
measure: waist circumference
timeFrame: Change from baseline to Week 12, Week 32, and Week 44
measure: hormonal measures of insulin sensitivity and safety
timeFrame: Percent change from baseline to Week 12, Week 32, and Week 44
measure: blood pressure
timeFrame: Change from baseline to Week 12, Week 32, and Week 44
measure: blood lipids
timeFrame: Change from baseline to Week 12, Week 32, and Week 44
measure: incidence of adverse events and lab abnormalities
timeFrame: throughout the study
measure: Change and percent change in body weight
timeFrame: at Week 32 from baseline and Week 12
measure: Time-matched change from baseline in QTc
timeFrame: at Week 12 and Week 32
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ucla Center For Human Nutrition
state: California
city: Washington
country: United States
facility: Domenica M. Rubino, Md
state: District of Columbia
city: Augusta
country: United States
facility: Csra Partners In Health, Inc
state: Georgia
city: Springfield
country: United States
facility: Springfield Diabetes And Endocrine Center
state: Illinois
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Charlotte
country: United States
facility: The Center For Nutrition & Preventive Medicine, Pllc
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Norfolk
country: United States
facility: Hampton Roads Center For Clinical Research Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: