ObesityPhase 2NCT00459004
Japanese Dose-Response Study of Rimonabant in Obese Patients
A Phase 2 study testing rimonabant (SR141716) in people with Obesity, run by Sanofi at 1 site in Japan.
Trial summary
The primary objective is to verify the dose-response relationship of rimonabant on body weight change. The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- rimonabant (SR141716)
- How many people
- 527 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2004to Apr 2006
- Phase
- Phase 2
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index ≥25 kg/m²
- Viceral Fat Area ≥ 100 cm²
- Diet therapy for more than 8 weeks before start of the placebo observation period
- Stable weight (variation < ±3kg within 8 weeks before start of observation period)
- At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-Response Relationship Study of SR141716 in Obese Patients
The primary objective is to verify the dose-response relationship of rimonabant on body weight change.
The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.
- Conditions
- Obesity
- Being tested
- rimonabant (SR141716)
- Keywords
- weight loss
- Medical subject headings
- Obesity, Weight Loss
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.
absolute change in body weight from baseline to Week 24
Secondary outcomes (3)
Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure
Safety:adverse events, laboratory tests, ECGs
Pharmacokinetics: SR141716 plasma trough concentrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startOct 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kohji SHIRAI, Professor, Principal investigator, Toho University Sakura Medical Center, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459004
- Sponsor's protocol ID
- DRI5747
- Status last verified
- Apr 2009
- First submitted
- 10 Apr 2007
- Last updated
- 7 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Response Relationship Study of SR141716 in Obese Patients
- ClinicalTrials.gov ID
- NCT00459004
- Acronym / sponsor ID
- DRI5747
- Conditions
- Obesity
- Keywords
- weight loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 11 Apr 2007 (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.
The primary objective is to verify the dose-response relationship of rimonabant on body weight change.
The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body Mass Index ≥25 kg/m²
- Viceral Fat Area ≥ 100 cm²
- Diet therapy for more than 8 weeks before start of the placebo observation period
- Stable weight (variation < ±3kg within 8 weeks before start of observation period)
- At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension
Key exclusion criteria (0 listed)
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
absolute change in body weight from baseline to Week 24
3 secondary outcomes
Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure
Safety:adverse events, laboratory tests, ECGs
Pharmacokinetics: SR141716 plasma trough concentrations
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 7 Apr 2009.
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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.
Kohji SHIRAI, Professor principal investigator
Toho University Sakura Medical Center, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rimonabant (SR141716) in people with Obesity, run by Sanofi at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. 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 7 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 1 site in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
absolute change in body weight from baseline to Week 24. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2009.