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BMS-646256 in Obese and High Risk Overweight Subjects
NCT00388609Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2006
- Primary completion
- Sep 2007
- Countries
- 1
- Sponsor
- Bristol Myers Squibb
- Drugs
- ibipinabant
- Conditions
- obesity
01
Overview
Phase 2, randomised, double-blind trial of ibipinabant in obesity (7 arms), sponsored by Bristol Myers Squibb. Primary endpoint: Percent change in body weight from the start of the study at 12 weeks. Started Nov 2006; status: terminated.
02
Design
7 arms- Study design
- RandomizedDouble-blind
Arm T
5 mg to 50 mg BMS-646256
Arm U
10 mg to 50 mg BMS-646256
Arm V
25 mg to 50 mg BMS-646256
Arm W
50 mg BMS-646256
Arm X
Titrated BMS-646256 (25mg then 5mg)
Arm Z
Open label BMS-646256 (50mg then 100mg)
1 more in the full profile.
03
Who it enrols
Adults aged 18-70 with BMI 30-45 kg/m² or BMI 27-30 kg/m² with hypertension or dyslipidemia. Excludes patients with diabetes, significant cardiovascular history, or psychiatric disorders including depression and suicidal ideation.
04
Endpoints
Primary
Percent change in body weight from the start of the study
Secondary
Change in body weight
Body Mass Index
Waist circumference
Hormonal measures of insulin sensitivity
Blood pressure
Blood lipids
Incidence of adverse events and lab abnormalities
Time-matched change from baseline in QTc
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