OverweightTOLERASITNCT05209997
Observational, Real-life, Retrospective, Data Collection, Use Sibutramine/topiramate in Overweight Comorbidities/obesity
An observational study of Overweight and Obesity, run by Eurofarma Laboratorios S.A. at 2 sites in Brazil.
Trial summary
An observational, multicenter, national study with retrospective real-life data collection on the combined treatment of sibutramine and topiramate (off-label use) for the treatment of overweight with comorbidity(ies) or obesity. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Source document data collection
- How many people
- 0 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, with prescribed treatment between the year 2011 and the beginning of the study
Who may be able to join
- Adult patients
- Both sexes
- Diagnose of overweight with comorbidity(ies) or obesity
- Treatment use of sibutramine combined with topiramate
- Treatment prescription between 2011 and the beginning of the study
Who cannot join
- Use of topiramate for other condition besides overweight with comorbidity(ies) or obesity
- Individual use of one of the medications (sibutramine or topiramate)
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Eurofarma Laboratórios S.A
São Paulo, São Paulo, 06696-000
HC-FMUSP
São Paulo, São Paulo
About this study
Official title: An Observational, Multicenter, National Study with Real-life Retrospective Data Collection on the Combined Use of Sibutramine and Topiramate As Anti-obesity Treatment in Overweight Patients with Comorbidity(ies) or Obesity.
An observational, multicenter, national study with retrospective real-life data collection on the combined treatment of sibutramine and topiramate (off-label use) for the treatment of overweight with comorbidity(ies) or obesity. Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be included in the study.
- Conditions
- Overweight, Obesity
- Being tested
- Source document data collection
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Source document data collectionOther
Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be colected in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who achieved a weight loss greater than 5%
Identification of the percentage of patients who achieved a weight loss greater than 5% in relation to the initial body weight.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Dec 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: The study was withdrawn following a thorough evaluation of the current scientific landscape and ongoing advancements in the field. This decision was made to ensure that the research remains aligned with the highest standards of innova
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209997
- Sponsor's protocol ID
- EF179
- Acronym
- TOLERASIT
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Multicenter, National Study with Real-life Retrospective Data Collection on the Combined Use of Sibutramine and Topiramate As Anti-obesity Treatment in Overweight Patients with Comorbidity(ies) or Obesity.
- ClinicalTrials.gov ID
- NCT05209997
- Acronym / sponsor ID
- TOLERASIT / EF179
- Conditions
- Overweight, Obesity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn following a thorough evaluation of the current scientific landscape and ongoing advancements in the field. This decision was made to ensure that the research remains aligned with the highest standards of innova
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Jan 2022 (actual)
- 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.
An observational, multicenter, national study with retrospective real-life data collection on the combined treatment of sibutramine and topiramate (off-label use) for the treatment of overweight with comorbidity(ies) or obesity. Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be included in the study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, with prescribed treatment between the year 2011 and the beginning of the study
Key inclusion criteria (5 listed)
- Adult patients
- Both sexes
- Diagnose of overweight with comorbidity(ies) or obesity
- Treatment use of sibutramine combined with topiramate
- Treatment prescription between 2011 and the beginning of the study
Key exclusion criteria (2 listed)
- Use of topiramate for other condition besides overweight with comorbidity(ies) or obesity
- Individual use of one of the medications (sibutramine or topiramate)
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 |
|---|---|---|
| Source document data collectionData from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be colected in the study. | Other | – |
Primary outcome
The percentage of patients who achieved a weight loss greater than 5%
Time frame: 20 years
Identification of the percentage of patients who achieved a weight loss greater than 5% in relation to the initial body weight.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Eurofarma Laboratorios S.A. at 2 sites in Brazil.
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 2 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: withdrawn, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The percentage of patients who achieved a weight loss greater than 5% (time frame: 20 years). 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 28 Feb 2025.