CClinicalTrials.gg
CompletedNCT00239174Updated Dec 10, 2008

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

A Phase 2 interventional study of SR147778 in Obesity, sponsored by Sanofi. Completed at 5 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-12-10.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
394
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

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Keywords

  • obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 394 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
394 participants (actual)

Interventions

  • DrugSR147778
06

What researchers measure

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.

07

Study locations

5 sites
  • Sanofi-Aventis Administrative Office
    Buenos Aires, Argentina
  • sanofi-aventis Australia & New Zealand administrative office
    Macquarie Park, Australia
  • Sanofi-Aventis Administrative Office
    Helsinki, Finland
  • Sanofi-Aventis Administrative Office
    Paris, France
  • Sanofi-Aventis Administrative Office
    Barcelona, Spain
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00239174
Lead sponsor
Sanofi
First posted
Oct 14, 2005
Start date
Nov 2004
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Dec 10, 2008

Study contacts

Martine Laville, MD
principal investigator · Hôpital Edouard Herriot, Endocrinologie-Diabète-Nutrition, 5 Place d'Arsonval, 69437 LYON cedex 03, France
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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