ObesityPhase 3RIO-LipidsNCT00029835
Obese Patients With Untreated Dyslipidemias
A Phase 3 study testing Rimonabant (SR141716) in people with Obesity and Dyslipidemia, run by Sanofi at 35 sites in 8 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Dyslipidemia
- What is being tested?
- Rimonabant (SR141716)
- How many people
- 1,033 participants
- Where
- 35 sitesin 8 countries
- Study dates
- Sep 2001to Nov 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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)
Trial locations and contacts
35 sites in 8 countries.
35 sites in 8 countries
United States28 sites
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106
Twin Cities Clinical Research
Arden Hills, Minnesota, 55126
Clinical Research Services
Bismarck, North Dakota, 58501
Medical University of South Carolina, Division of Clinical Pharmacology
Charleston, South Carolina, 29425
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267-0559
Clinical Research of South Florida
Coral Gables, Florida, 33134
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Radiant Research
Edina, Minnesota, 55435
Clinical Research Center of Northern Virginia
Falls Church, Virginia, 22044
Irvine Center for Clinical Research (ICCR)
Irvine, California, 92618
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510
Los Angeles Clinical Trials
Los Angeles, California, 90064
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291
Johns Hopkins Women's Research Core
Lutherville, Maryland, 21093
Clinic of Physicians and Surgeons, LTD
Mesa, Arizona, 85201
Addiction & Psychiatric Medicine Research
Morgantown, West Virginia, 26506-9300
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Clinical Research Division
Newtown, Pennsylvania, 18940
nTouch Research
Peoria, Illinois, 61602
Hunter Holmes McGuire Medical Center Research Service (151)
Richmond, Virginia, 23249
Radiant Research
Salt Lake City, Utah, 84111
Apexute
Santa Ana, California, 92705
nTouch Research
South Bend, Indiana, 46601
Baystate Medical Center
Springfield, Massachusetts, 01199
Radiant Research
Stuart, Florida, 34996
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85712
Vancouver Medical Weight Loss Clinic
Vancouver, Washington, 98685
Clinical Research Center of Reading, LLC
West Reading, Pennsylvania, 19611-1124
About this study
Official title: 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
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
- Conditions
- Obesity, Dyslipidemia
- Being tested
- Rimonabant (SR141716)
- Keywords
- Obesity
- Medical subject headings
- Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimonabant (SR141716)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body weight at 1 year.
Secondary outcomes (1)
Metabolic parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2002 (estimated)
- Study startSep 2001
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029835
- Sponsor's protocol ID
- EFC4735
- Acronym
- RIO-Lipids
- Status last verified
- Apr 2009
- First submitted
- 23 Jan 2002
- Last updated
- 20 Apr 2009
- Results posted
- No
Publications
Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34. doi: 10.1056/NEJMoa044537.
PubMed 16291982
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00029835
- Acronym / sponsor ID
- RIO-Lipids / EFC4735
- Conditions
- Obesity, Dyslipidemia
- Keywords
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,033 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 24 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rimonabant (SR141716) | Drug | – |
Primary outcome
Change from baseline in body weight at 1 year.
1 secondary outcome
Metabolic parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2009.
- Results publication: PubMed 16291982Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34. doi: 10.1056/NEJMoa044537.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
35 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant (SR141716) in people with Obesity and Dyslipidemia, run by Sanofi at 35 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Australia, Canada, Finland, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in body weight at 1 year.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2009.