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CompletedNCT00481975Updated Apr 7, 2009

Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients

A Phase 3 interventional study of rimonabant (SR141716) in Obesity and Eating Disorders, sponsored by Sanofi. Completed at 7 sites in 7 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-04-07.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
289
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The primary objective is to assess the effect of rimonabant compared to placebo on weight loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients with binge eating disorder.

The secondary objectives are:

  • to assess the effect of rimonabant on the number of binge episodes per week, to assess the effect of rimonabant on eating behavior using the Binge Eating Scale (BES) and Three Factor Eating Questionnaire (TFEQ),
  • to evaluate the safety and tolerability of rimonabant over a period of 6 months.
02

Conditions studied

  • Obesity
  • Eating Disorders

Keywords

  • binge eating
  • eating disorders
  • obesity
03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 289 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss 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 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Body Mass Index (BMI) ≥30 to ≤45 kg/m²
  • Diagnosis of eating disorder using The Questionnaire on Eating and Weight Patterns (QEWP-R) for diagnosing Eating Behaviors

Exclusion criteria

Exclusion Criteria:

  • History of surgical procedures for weight loss
  • Treatment with anti-obesity drugs within 3 months prior to screening visit
  • Presence or history of Diagnostic and Statistical Manual of Mental Disorders (4th edition)(DSM IV) bulimia or anorexia nervosa

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
289 participants (actual)

Interventions

  • Drugrimonabant (SR141716)
06

What researchers measure

Primary outcomes

  1. Change in body weight from baseline to Day 180 visit

Secondary outcomes

  1. Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index

  2. Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale

07

Study locations

7 sites
  • Sanofi-Aventis Administrative Office
    Bridgewater, New Jersey 08807, United States
  • Sanofi-Aventis Administrative Office
    Helsinki, Finland
  • Sanofi-Aventis Administrative Office
    Paris, France
  • Sanofi-Aventis Administrative Office
    Gouda, Netherlands
  • Sanofi-Aventis Administrative Office
    Porto Salvo, Portugal
  • Sanofi-Aventis Administrative Office
    Bromma, Sweden
  • Sanofi-Aventis Administrative Office
    Geneva, Switzerland
08

References and documents

Publications

  • Pataky Z, Gasteyger C, Ziegler O, Rissanen A, Hanotin C, Golay A. Efficacy of rimonabant in obese patients with binge eating disorder. Exp Clin Endocrinol Diabetes. 2013 Jan;121(1):20-6. doi: 10.1055/s-0032-1329957. Epub 2012 Nov 12. PubMed 23147209 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00481975
Lead sponsor
Sanofi
First posted
Jun 4, 2007
Start date
Aug 2004
Primary completion
Aug 2005
Completion
Aug 2005
Last update
Apr 7, 2009

Study contacts

ICD CSD
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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