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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00239174
First received: October 13, 2005
Last updated: December 9, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: SR147778
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study Evaluating the Efficacy and Safety of Four Doses of SR147778 in Obese Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Weight loss at 6 months.

Secondary Outcome Measures:
  • 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.

Enrollment: 394
Study Start Date: November 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%).

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239174

Locations
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, Australia
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Martine Laville, MD Hôpital Edouard Herriot, Endocrinologie-Diabète-Nutrition, 5 Place d'Arsonval, 69437 LYON cedex 03, France
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00239174     History of Changes
Other Study ID Numbers: DRI5029
Study First Received: October 13, 2005
Last Updated: December 9, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency

Keywords provided by Sanofi:
obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014