Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)

A Randomized Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen (SR141716 20 mg), Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Patients With Dyslipidemia.

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.

Inclusion Criteria:

• Body Mass Index (BMI) > 25 kg/m²

• Visceral Fat Area (VFA) > 100 cm²

• Triglycerides (TG) > 150 mg/dL and < 700 mg/dL, and/or HDL-cholesterol < 40 mg/dL(Dyslipidemia)

• At least 1 criteria of the following 2 comorbidities:

  • Impaired Glucose Tolerance or Type 2 diabetes
  • Hypertension

Exclusion Criteria:

• Patient with a secondary obesity.
• Patients who have received the diet therapy for less than 8 weeks before start of the observation period.
• Patients whose body weight changed by more than the variation of ± 2kg for screening period.
• Low compliance to drug intake (< 80%) and dietary instruction during the observation period.
• Patients with type 1 diabetes.
• Patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type III hyperlipidemia).
• Patients with a LDL-cholesterol > 190 mg/dL at any of Weeks -8 or -4.
• Patients with a secondary hypertension.