A Multicenter Study to Evaluate the Efficacy and Safety of of Four Doses of SR147778 in Obese Patients

Exclusion Criteria

• •Female patients who are pregnant or lactating,
• •Patients who are considered by the Investigator to be unsuitable candidates for receipt of an investigational drug,
• •Myocardial infarction within 12 months,
• •Hypertension (SBP \> 160 mmHg; DBP \> 95 mmHg),
• •Secondary hypertension- Confirmed heart rate \< 60 beats/minute,
• •Type 1 diabetes, or treated with insulin
• •History or presence of pancreatitis,
• •History or presence of clinically significant cardiac valve disorder or abnormal cardiac echography.
• •History or concurrent DSM-IV bulimia or anorexia nervosa,
• •Patients with mental retardation or any clinically significant psychiatric disorder (including organic mental disorder) other than mild mood or anxiety,
• •History (during the past six months) or concurrent DSM-IV substance abuse or dependence (excluding nicotine and caffeine as far as patient agrees not to modify her/his consumption throughout the study),
• •Severe or multiple drug allergies,
• •Any disorder that may interfere with drug absorption, metabolism distribution or excretion,
• •Presence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease, or any other medical condition that might interfere with the evaluation of study medication,
• •Prolonged QTcB: \> 450 msec for men and \> 470 msec for women.
• •Patients who test positive for any illicit drug included in the urine drug screen (THC) at the Screening or the Baseline Visit. Patients positive for benzodiazepines only may be admitted, if prescribed with stable dose regimen.
• •Patients who test positive at the Screening Visit for hepatitis B surface antigen, hepatitis C antibody, or ALT and/or AST \> 2 x upper limit of normal,
• •Hb \< 11g/dL, fasting glycemia \> 1.6 g/L i.e. 8.9 mmol/L, HbA1c \> 8%, total cholesterolemia \> 3 g/L i.e. 7.7 mmol/L, or TG \> 7 g/L i.e. 7.9 mmol/L, creatinemia \> 150 mmol/l- Patients who have received anti-obesity drugs or other drug(s) or preparation(s) including herbal for weight reduction within three months of Screening Visit,
• •Thyroid therapy, except on replacement therapy.
• •Patients using nicotine substitutes or taking bupropion,
• •Treated with antidepressant or neuroleptics drug(s) for more than one week within three months of Screening Visit,
• •Treated with non selective systemic antihistamines
• •Systemic corticosteroids or inhaled corticosteroids
• •Treated with potent inhibitors of CYP3A4
• •Consuming more than 20 g/day of alcohol.