Obese Patients With or Without Comorbidities (RIO-North America)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing and Prevention of Weight Regain Effects and Safety in Obese Patients With or Without Comorbidities

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00029861

Enrollment

3045

Registered

2002-01-24

Start date

2001-08-31

Completion date

2004-04-30

Last updated

2009-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Weight Loss

Keywords

Weight Loss, Obesity, Weight Reduction, Overweight

Brief summary

To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities

Interventions

DRUGRimonabant (SR141716)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stable weight (variation of less than 5 kg within 3 months prior to screening visit) * BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia

Design outcomes

Primary

Measure	Time frame
Change in body weight	—

Secondary

Measure	Time frame
Metabolic parameters	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026