High Density Lipoprotein Turnover

The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period.

Primary objectives:

* To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR).

Secondary objectives:

* To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics.
* To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters
* To assess effect of Rimonabant on body composition
* To assess safety of Rimonabant


Eligibility Criteria:
Inclusion Criteria:

* Abdominally obese patients with additional cardiometabolic risk factors
* Females must be post-menopausal
* BMI \> 27 kg/m² and \< 40 kg/m²
* Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference \> 88 cm in women; \> 102 cm in men
* With at least one lipid abnormality defined as:
* Fasting Triglycerides level \> 1.7 mmol/L (150 mg/dL) and \< 4.5 mmol/L (400 mg/dL)
* HDL \< 1.03 mmol/L (40 mg/dL) in men and \< 1.29 mmol/L (50 mg/dL) in women

Exclusion Criteria:

* HDL ≤ 0.60 mmol/L (23 mg/dl)
* Plasma LDL-Cholesterol \> 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (\> 6.5mmol/L) or genetic hyperlipidaemia
* Fasting triglycerides \> 400 mg/dL (4.5 mmol/L)
* Known heterozygous or homozygous familial hypercholesterolaemia or know type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
* ApoE2/E2 homozygosity, Apo E4/E4 homozygosity
* Type 2 diabetes treated with oral agents and/or insulin
* Diet treated type 2 diabetic patients with HbA1c ≥ 7%
* History of cardio vascular disease
* Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg.
* Very low-calorie diet (1200 calories a day or less) or history of surgical procedures for weight loss (e.g., stomach stapling, bypass)
* Body weight fluctuation \> 5 Kg during the previous 3 months
* History of bulimia or anorexia nervosa by DSM-IV criteria
* Presence of any clinically significant endocrine disease according to the investigator, Cushing syndrome, obesity secondary to hypothalamic/pituitary disorder.
* Abnormal TSH and free T4 at baseline (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status.)
* Severe hepatic impairment known by the investigator or AST or ALT \> 3 times the ULN at screening.
* Known severe renal dysfunction (creatinine clearance \< 30 ml/min) or urine analysis (performed at screening by dipstick) showing 2+ or more protein
* Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient safety or limit his/her successful participation to the study
* Patient treated for epilepsy
* Ongoing major depressive illness
* Uncontrolled psychiatric illness
* History of alcohol and/or drug abuse
* Smoker or smoking cessation within the past 3 months
* Marijuana or hashish users
* Previous participation in a Rimonabant study or to any other clinical trial within 4 weeks to study start
* Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose
* Blood donation within the past 3 months prior to the study or planned during the study or within the 3 months from the study completing
* Recent history of active peptic ulcer
* Willebrand disease or other hemorrhagic diatheses
* Administration of any of the following within 3 months prior to screening visit and susceptible to be prescribed during the study treatment period:
* Lipid-lowering drugs intake
* Anti obesity drugs
* Other drugs for weight reduction (phentermine, amphetamines)
* Herbal preparations for weight reduction
* Other drugs known to affect lipid metabolism: retinoids, antiretroviral, estrogens and hormone replacement therapy, cyclosporine, glitazones, benfluorex, fish oils, plant sterols.
* Thiazids (including fixed combination) at daily dose higher than 12.5 mg
* Unselective beta-blockers
* Prolonged use (more than one week) of systemic corticosteroids, neuroleptics
* Anticoagulants
* Ongoing antidepressive treatment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.