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

NCT00239174 | Completed Phase 2

• 1 other identifier: DRI5029
• Study Type: interventional
• Target: 394
• Locations: 5 countries
• Sites: 5

Brief Summary

The purpose of this study is to assess the effect of SR147778 on weight loss over a period of 24 weeks when prescribed with a hypocaloric diet in obese patients. The secondary objective is to assess the safety and tolerability of SR147778 and 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.

Conditions

Obesity

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

• Weight loss at 6 months.

Secondary Outcomes (1)

• Waist circumference,lipid parameters,glycemic parameters,metabolic syndrome,blood pressure,adipokines,CRP,IL-6,IL-2,patient satisfaction,food behavior,daily caloric intake, and dietary compliance at 6 months.

Interventions

SR147778 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must voluntarily sign the informed consent,
• Patients must be male or female and aged 18 to 65 years,
• Patients must be able to follow verbal and written instructions,
• Female patients of childbearing potential (pre-menopausal women) must have a confirmed negative urine b-hCG pregnancy test prior to enrollment and Baseline Visit. They must use an acceptable double method of birth control (e.g., oral or implanted contraceptive therapy, or IUDs, plus a barrier such as condom, diaphragm or spermicide) throughout the study, and accept to repeat urine b-hCG pregnancy test at designated visits,
• Patients must have a BMI \>=30 and \<= 40 at screening
• Patients must have had a stable weight (variation of less than 5 kg during the 90 days preceding the Screening Visit)
• Patients must have shown to be compliant to dietary recommendations between the Screening and the Baseline Visits
• Patients' physical examination, laboratory evaluations, 12-lead ECG must be within normal limits (with the exception of abnormalities considered as clinically insignificant in the opinion of the Investigator and the Center Monitor), or within predefined limits for hemoglobin (\>= 11 g/dL), 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), and hemoglobin A1c (\<= 8%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (5)

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Location

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, Australia

Location

Sanofi-Aventis Administrative Office

Helsinki, Finland

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity

Interventions

surinabant

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martine Laville, MD

  Hôpital Edouard Herriot, Endocrinologie-Diabète-Nutrition, 5 Place d'Arsonval, 69437 LYON cedex 03, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 14, 2005
• Study Start: November 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: December 10, 2008

Record last verified: 2008-12

Locations

ES (1); AU (1); FI (1); AR (1); FR (1)