The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities. The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,507
Sanofi-Aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis
Brussels, Belgium
Sanofi-Aventis
Helsinki, Finland
Sanofi-Aventis
Paris, France
change in body weight from baseline to 1 year.
HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.
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Sanofi-Aventis
Berlin, Germany
Sanofi-Aventis
Gouda, Netherlands
Sanofi-Aventis
Bromma, Sweden