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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Obesity

Treatments: Drug: BMS-646256; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00388609

MB109-007

Details and patient eligibility

About

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

Enrollment: 705 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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705 participants in 7 patient groups, including a placebo group

T

Experimental group

Description:

5 mg (ST) to 50 mg (LT)

Treatment:

Drug: BMS-646256

U

Experimental group

Description:

10 mg (ST) to 50 mg (LT)

Treatment:

Drug: BMS-646256

V

Experimental group

Description:

25 mg (ST) to 50 mg (LT)

Treatment:

Drug: BMS-646256

W

Experimental group

Description:

50 mg (ST and LT)

Treatment:

Drug: BMS-646256

X

Experimental group

Description:

25 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT)

Treatment:

Drug: BMS-646256

Z

Experimental group

Description:

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)

Treatment:

Drug: BMS-646256

Y

Placebo Comparator group

Description:

0 mg (ST and LT)

Treatment:

Drug: Placebo