The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks. Secondary objectives are: * To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area. * To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks. * To evaluate the pharmacokinetics of SR141716.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
915
oral administration once daily
oral administration once daily
Sanofi-Aventis Administrative Office
Tokyo, Japan
body weight: relative change from baseline
Time frame: Week 52
triglycerides: relative change from baseline
Time frame: Week 52
HDL-cholesterol ;visceral fat area
Time frame: Week 52
Safety: Adverse events
Time frame: study period
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