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Obese Patients With Untreated Dyslipidemias

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study of Weight-Reducing Effect and Safety in Obese Patients With Untreated Dyslipidemias

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00029835
Acronym
RIO-Lipids
Enrollment
1033
Registered
2002-01-24
Start date
2001-09-30
Completion date
2003-11-30
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

Dyslipidemia, Obesity

Keywords

Obesity

Brief summary

To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia

Interventions

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* BMI must be greater than 27 and less than 40 * Patients with untreated dyslipidemia * Stable weight (variation of less than 5 kg within 3 months prior to screening visit)

Design outcomes

Primary

MeasureTime frame
Change from baseline in body weight at 1 year.

Secondary

MeasureTime frame
Metabolic parameters

Countries

Australia, Canada, Finland, Italy, Spain, Sweden, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026