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CompletedNCT00481923REBAUpdated Apr 20, 2009

Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients

A Phase 3 interventional study of rimonabant (SR141716) in Obesity, sponsored by Sanofi. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-20.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to assess the effect of rimonabant on the energy intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice, cravings and feelings of control.

The secondary objectives are to determine the effect of rimonabant on body weight with or without hypocaloric diet and its clinical and laboratory safety.

02

Conditions studied

  • Obesity

Keywords

  • hypocaloric diet
  • energy intake
03

In context

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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Obese subjects with Body Mass Index ≥ 30 and \< 45 kg/m²

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
156 participants (actual)

Interventions

  • Drugrimonabant (SR141716)
06

What researchers measure

Primary outcomes

  1. Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment.

Secondary outcomes

  1. Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days

  2. Clinical Safety

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Guilford, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00481923
Lead sponsor
Sanofi
First posted
Jun 4, 2007
Start date
May 2004
Primary completion
Apr 2005
Completion
Apr 2005
Last update
Apr 20, 2009

Study contacts

John Blundell, Pr
principal investigator · University of Leeds, United Kingdom
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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