Obesity is becoming a major health problem in western societies. Its prevalence is increasing especially in USA, UK, and Germany. Obesity is responsible for increased morbidity and mortality. The comorbid conditions associated with obesity include hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, respiratory dysfunction, sleep apnea, gout, gallbladder disease, osteoarthritis, and cancer. MedDRA version: 7.0 Level: LLT Classification code 10029883
Conditions
Interventions
Product Code: SR147778
Pharmaceutical Form: Capsule, soft
CAS Number: 288104-79-0
Current Sponsor code: SR147778
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5
Sponsors
Sanofi-Synthelabo AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients must have a BMI = 30 and = 40 at screening, - total cholesterolemia (= 3 g/L, i.e. 7.7 mmol/L), - triglyceridemia (= 7 g/L, i.e. 7.9 mmol/L), - fasting glycemia (= 1.6 g/L, i.e.8.9 mmol/L), - hemoglobin A1c (= 8%). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - patients with concurrent hypertension (systolic blood pressure > 160 mmHg; diastolic blood pressure > 95 mmHg), - patients who have a 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, - patients who are treated with potent inhibitors of CYP3A4 (itraconazole, nefazodone, saquinavir, ritonavir, ketoconazole) or specific moderate inhibitors (grapefruit juice, clarithromycin, erythromycin, diltiazem and verapamil). Patients with the other inhibitors of CYP3A4 can be included but it is a advised to seek for alternative treatment not affecting CYP3A4 before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of SR147778 on weight loss over a period of 24 weeks when prescribed with a hypocaloric diet in obese patients.;Secondary Objective: · To assess the safety and tolerability of SR147778 over a period of 24 weeks when prescribed with a hypocaloric diet in obese patients. · To assess the effect of SR147778 on several secondary parameters (such as waist, metabolic parameters, …) over a period of 24 weeks when prescribed with a hypocaloric diet in obese patients.;Primary end point(s): - Absolute change from baseline (D-1) in body weight at D168 (= 6 months). - Percentage of responders at 5% (weight loss ³ 5% from baseline) at D168 - Percentage of responders at 10% (weight loss ³ 10% from baseline) at D168, - Absolute and relative change from baseline over time by visit | — |
Countries
Finland, Spain
Outcome results
None listed