OverweightPhase 3UNLIMITEDNCT05209984
A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight
A Phase 3 study testing ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mg, ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mg and SIB Group Sibus (Sibutramine) 15mg in people with Overweight and Obesity, run by Eurofarma Laboratorios S.A. at 2 sites in Brazil.
Trial summary
A phase 3, multicenter, randomized, double-blind, double-dummy, parallel-group, active-drug- and placebo-controlled clinical trial to assess the safety, efficacy and superiority of the new fixed-dose combination sibutramine IR/topyramat XR in weight reduction in overweight adults with comorbidity(ies) or obesity Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mg, ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mg and SIB Group Sibus (Sibutramine) 15mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesBrazil
- Study dates
- Apr 2026to Mar 2028
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female volunteers aged between 18 and 60 years (inclusive);
- BMI ≥ 27kg/m2 and < 45kg/m2. Patients with a BMI ≥ 27kg/m2 and < 30kg/m2 must have at least one of the following comorbidities to be included in the study: dyslipidemia, systemic arterial hypertension (SAH), pre-diabetes (fasting glucose ≥ 100mg/dL and < 126 mg/dL and/or HbA1c ≥ 5.7% and < 6.5%] and/or sleep apnea (confirmed by polysomnography performed up to three months before enrollment in the study);
- Women of childbearing age must use adequate contraceptive methods;
- Volunteers willing and able to comply with all aspects of the protocol;
- Signing the Informed Consent Form (ICF) before performing any study procedure.
Who cannot join
- Participation in a lifestyle change program within the three months prior to the start of the study;
- Treatment with drugs (prescription or over-the-counter) or alternative drugs intended to promote weight loss within the three months prior to the start of the study. These medications include, among others: liraglutide, orlistat, sibutramine, topiramate, naltrexone, bupropion, sertraline, fluoxetine, duloxetine. Note: The use of metformin or other hypoglycemic drugs prescribed for the treatment of polycystic ovary syndrome or prevention of diabetes is not permitted;
- Treatment with drugs known to cause significant weight gain within three months of starting the study. These medications include, among others: corticosteroids, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, lithium).
- Presence of diabetes mellitus;
- History of coronary artery disease (angina, history of myocardial infarction);
- Congestive heart failure;
Show all 24Show fewer
- History of tachycardia;
- History of peripheral obstructive arterial disease;
- History of arrhythmia;
- History of cerebrovascular disease (stroke or transient ischemic attack);
- Inadequately controlled systemic arterial hypertension (> 145/90 mmHg);
- History or active pulmonary arterial hypertension;
- History or presence of eating disorders such as bulimia and anorexia;
- Moderate or severe renal impairment (estimated creatinine clearance < 70 mL/min);
- Hepatic failure Child-Pugh categories B or C (Child-Pugh scale score ≥ 7 points);
- Current use of monoamine oxidase inhibitors (MAOIs) or any other drug treatment for psychiatric disorders;
- History of psychiatric disorder requiring previous drug treatment;
- Glaucoma or high intraocular pressure;
- Unstable thyroid disease or replacement therapy;
- Hypersensitivity to sibutramine, topiramate, or to any component of the investigational product formulation;
- Known hypersensitivity to any component of the investigational drug formulation;
- Urinary lithiasis;
- Pregnancy or lactation;
- Any medical or other condition that, in the opinion of the investigator(s), prevents the participant from participating in the clinical trial, such as significantly abnormal laboratory results or any physical or mental condition that prevents compliance with the protocol.
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: A Phase 3, Randomized, Double-blind, Double-dummy, Parallel-group, Active Drug and Placebo-controlled, Safety, Efficacy and Superiority of Sibutramine IR/Topiramate XR in Overweight Adults With Comorbidities/Obesity
A phase 3, multicenter, randomized, double-blind, double-dummy, parallel-group, active-drug- and placebo-controlled clinical trial to assess the safety, efficacy and superiority of the new fixed-dose combination sibutramine IR/topyramat XR in weight reduction in overweight adults with comorbidity(ies) or obesity
Read the detailed description
A phase 3, multicenter, national, randomized, double-blind, double-dummy, parallel-group, active-drug and placebo-controlled, superiority clinical trial. Individuals of both sexes aged ≥18 years and ≤60 years, overweight (BMI ≥ 27kg/m2) in the presence of comorbidities (dyslipidemia, systemic arterial hypertension [SAH], pre-diabetes and/or sleep apnea) or obese (BMI ≥ 30kg/m2 and < 45kg/m2).
- Conditions
- Overweight, Obesity
- Being tested
- ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mg, ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mg, SIB Group Sibus (Sibutramine) 15mg, Placebo Group
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mgDrug
Also called EF178 15/75mg
Participant will receive for two (2) weeks one (01) ADF sibutramine IR/topiramate XR 5mg/25mg placebo capsule once daily + one (01) sibutramine placebo capsule 10mg; after that 2 weeks, participants will receive one (01) placebo capsule of ADF sibutramine IR/ topiramate XR 5mg/25mg once daily + one (01) capsule of ADF sibutramine IR/ topiramate XR 5mg/25mg once daily + one (01) 10mg sibutramine placebo capsule; after this period, they will receive two (02) capsules of ADF sibutramine IR/topiramate XR 5mg/25mg (totaling 10mg of sibutramine and 50mg of topiramate) + a placebo capsule of ADF sibutramine IR/topiramate XR 5mg/25mg once a day + one (one) 10mg sibutramine placebo capsule, taken once daily, for two (02) additional weeks, on the titration scheme. On the treatment period, will receive one (01) ADF Sibutramine IR/Topiramate XR 15mg/75mg capsule + one (01) Sibutramine IR 15mg placebo capsule (Sibus®) + one (01) Topiramate XR 100mg placebo capsule, once daily, for 52 weeks.
ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mgDrug
Also called EF178 15/100mg
Participant will receive for two (02) weeks one (01) capsule of ADF sibutramine IR/topiramate XR 5mg/25mg once daily + one (01) capsule of placebo sibutramine 10mg; after this initial period of 2 weeks, participants will receive (02) ADF sibutramine IR/topiramate XR 5mg/25mg capsules (totaling 10mg of sibutramine and 50mg of topiramate) + one (01) 10mg sibutramine placebo capsule, taken once daily, for two (02) weeks; after this period, they will receive three (03) capsules of ADF sibutramine IR/topiramate XR 5mg/25mg (totaling 15mg of sibutramine and 75mg of topiramate) + one (01) capsule of 10mg sibutramine placebo, taken once daily, for two ( 02) additional weeks, on titration scheme. On the treatment period, will receive one (01) Sibutramine IR 15mg capsule (Sibus®) + one (01) Topiramate XR 100mg capsule + one (01) ADF placebo capsule sibutramine IR/topiramate XR 15mg/75mg, taken once daily, taken once daily, for 52 weeks.
SIB Group Sibus (Sibutramine) 15mgDrug
Also called Sibutramine 15mg
Participant will receive for two (02) weeks one (01) 10mg sibutramine placebo capsule + one (01) 5mg/25mg sibutramine ADF placebo capsule IR/topiramate XR; after this initial period, they will receive for two (02) weeks one (01) 10mg sibutramine capsule + two (02) placebo capsules of ADF sibutramine IR/topiramate XR 5mg/25mg; after this 4-week period, participants will receive one (01) 10mg sibutramine capsule and three (03) ADF sibutramine IR/topiramate XR 5mg/25mg placebo capsules, taken once daily, for two (02) additional weeks. This corresponds to the titration scheme.On the treatment period, patient will receive one (01) Sibutramine 15mg capsule + one (01) Sibutramine IR/topiramate XR 15mg/75mg placebo capsule + one (01) placebo capsule of Topiramate XR 100mg, taken once daily, for 52 weeks.
Placebo GroupDrug
Also called Ef178 Placebo
participants randomized to the Placebo Group will receive for two (02) weeks one (01) 10mg sibutramine placebo capsule + one (01) sibutramine IR/ topiramate XR 5mg/25mg placebo capsule; after this initial period, they will receive one (01) sibutramine 10mg placebo capsule + two (02) sibutramine IR/ topiramate XR 5mg/25mg placebo capsules, taken once daily, for two (02) weeks; after this 4-week period, participants will receive one (01) 10mg sibutramine placebo capsule + three (03) ADF placebo capsules, taken once daily, for two (02) weeks.On the treatment period, patient will receive one (01) Sibutramine 15mg placebo capsule + one (01) ADF sibutramine IR/Topiramate XR 15mg/75mg placebo capsule + one (01) Topiramate XR 100mg placebo capsule, in once daily intake for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental drug (Sibutramine IR 15mg / Topiramate XR 75mg) | Experimental | ADF1 Group Eurofarma drug association of sibutramine IR 15mg / topiramate XR 75mg Receives: Drug: ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mg |
| Experimental drug (Sibutramine IR 15mg / Topiramate XR 100mg) | Experimental | ADF2 Group Eurofarma drug association of sibutramine IR 15mg (Sibus®) Topiramate XR 100mg from Eurofarma Laboratórios S.A.. Receives: Drug: ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mg |
| Sibus (Sibutramine 15mg) | Active comparator | SIB Group Sibutramine 15mg Receives: Drug: SIB Group Sibus (Sibutramine) 15mg |
| Placebo Group | Placebo comparator | Placebo Group Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
The difference in mean percent body weight loss between the ADF sibutramine IR/topiramate XR group and the placebo-treated group is ≥5% in favor of ADF.
Measured: 58 weeks
The mean percentage loss of body weight
The mean percentage loss of body weight in the ADF sibutramine IR/topiramate XR group was greater than that observed in the group treated with sibutramine IR
Measured: 58 weeks
Secondary outcomes (4)
Proportion of participants with weight reduction ≥ 5%
Proportion of participants with weight reduction ≥ 5% at the end of treatment in relation to baseline weight;
Measured: 58 weeks
Proportion of participants with weight reduction ≥ 10%
Proportion of participants with weight reduction ≥ 10% at the end of treatment in relation to baseline weight
Measured: 58 weeks
Proportion of participants with weight reduction ≥ 15%
Proportion of participants with weight reduction ≥ 15% at the end of treatment in relation to baseline weight;
Measured: 58 weeks
Abdominal circumference
The measurement of abdominal circumference
Measured: 58 weeks
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 startApr 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Why it stopped: Strategic change in development priorities
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT05209984
- Sponsor's protocol ID
- EF178
- Acronym
- UNLIMITED
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Double-dummy, Parallel-group, Active Drug and Placebo-controlled, Safety, Efficacy and Superiority of Sibutramine IR/Topiramate XR in Overweight Adults With Comorbidities/Obesity
- ClinicalTrials.gov ID
- NCT05209984
- Acronym / sponsor ID
- UNLIMITED / EF178
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic change in development priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (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.
A phase 3, multicenter, randomized, double-blind, double-dummy, parallel-group, active-drug- and placebo-controlled clinical trial to assess the safety, efficacy and superiority of the new fixed-dose combination sibutramine IR/topyramat XR in weight reduction in overweight adults with comorbidity(ies) or obesity
Detailed description
A phase 3, multicenter, national, randomized, double-blind, double-dummy, parallel-group, active-drug and placebo-controlled, superiority clinical trial. Individuals of both sexes aged ≥18 years and ≤60 years, overweight (BMI ≥ 27kg/m2) in the presence of comorbidities (dyslipidemia, systemic arterial hypertension [SAH], pre-diabetes and/or sleep apnea) or obese (BMI ≥ 30kg/m2 and < 45kg/m2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental drug (Sibutramine IR 15mg / Topiramate XR 75mg) | Experimental | Drug: ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mgADF1 Group Eurofarma drug association of sibutramine IR 15mg / topiramate XR 75mg |
| Experimental drug (Sibutramine IR 15mg / Topiramate XR 100mg) | Experimental | Drug: ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mgADF2 Group Eurofarma drug association of sibutramine IR 15mg (Sibus®) Topiramate XR 100mg from Eurofarma Laboratórios S.A.. |
| Sibus (Sibutramine 15mg) | Active comparator | Drug: SIB Group Sibus (Sibutramine) 15mgSIB Group Sibutramine 15mg |
| Placebo Group | Placebo comparator | Drug: Placebo GroupPlacebo Group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female volunteers aged between 18 and 60 years (inclusive);
- BMI ≥ 27kg/m2 and < 45kg/m2. Patients with a BMI ≥ 27kg/m2 and < 30kg/m2 must have at least one of the following comorbidities to be included in the study: dyslipidemia, systemic arterial hypertension (SAH), pre-diabetes (fasting glucose ≥ 100mg/dL and < 126 mg/dL and/or HbA1c ≥ 5.7% and < 6.5%] and/or sleep apnea (confirmed by polysomnography performed up to three months before enrollment in the study);
- Women of childbearing age must use adequate contraceptive methods;
- Volunteers willing and able to comply with all aspects of the protocol;
- Signing the Informed Consent Form (ICF) before performing any study procedure.
Key exclusion criteria (24 listed)
- Participation in a lifestyle change program within the three months prior to the start of the study;
- Treatment with drugs (prescription or over-the-counter) or alternative drugs intended to promote weight loss within the three months prior to the start of the study. These medications include, among others: liraglutide, orlistat, sibutramine, topiramate, naltrexone, bupropion, sertraline, fluoxetine, duloxetine. Note: The use of metformin or other hypoglycemic drugs prescribed for the treatment of polycystic ovary syndrome or prevention of diabetes is not permitted;
- Treatment with drugs known to cause significant weight gain within three months of starting the study. These medications include, among others: corticosteroids, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, lithium).
- Presence of diabetes mellitus;
- History of coronary artery disease (angina, history of myocardial infarction);
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 |
|---|---|---|
| ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mgAlso: EF178 15/75mgParticipant will receive for two (2) weeks one (01) ADF sibutramine IR/topiramate XR 5mg/25mg placebo capsule once daily + one (01) sibutramine placebo capsule 10mg; after that 2 weeks, participants will receive one (01) placebo capsule of ADF sibutramine IR/ topiramate XR 5mg/25mg once daily + one (01) capsule of ADF sibutramine IR/ topiramate XR 5mg/25mg once daily + one (01) 10mg sibutramine placebo capsule; after this period, they will receive two (02) capsules of ADF sibutramine IR/topiramate XR 5mg/25mg (totaling 10mg of sibutramine and 50mg of topiramate) + a placebo capsule of ADF sibutramine IR/topiramate XR 5mg/25mg once a day + one (one) 10mg sibutramine placebo capsule, taken once daily, for two (02) additional weeks, on the titration scheme. On the treatment period, will receive one (01) ADF Sibutramine IR/Topiramate XR 15mg/75mg capsule + one (01) Sibutramine IR 15mg placebo capsule (Sibus®) + one (01) Topiramate XR 100mg placebo capsule, once daily, for 52 weeks. | Drug | Experimental drug (Sibutramine IR 15mg / Topiramate XR 75mg) |
| ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mgAlso: EF178 15/100mgParticipant will receive for two (02) weeks one (01) capsule of ADF sibutramine IR/topiramate XR 5mg/25mg once daily + one (01) capsule of placebo sibutramine 10mg; after this initial period of 2 weeks, participants will receive (02) ADF sibutramine IR/topiramate XR 5mg/25mg capsules (totaling 10mg of sibutramine and 50mg of topiramate) + one (01) 10mg sibutramine placebo capsule, taken once daily, for two (02) weeks; after this period, they will receive three (03) capsules of ADF sibutramine IR/topiramate XR 5mg/25mg (totaling 15mg of sibutramine and 75mg of topiramate) + one (01) capsule of 10mg sibutramine placebo, taken once daily, for two ( 02) additional weeks, on titration scheme. On the treatment period, will receive one (01) Sibutramine IR 15mg capsule (Sibus®) + one (01) Topiramate XR 100mg capsule + one (01) ADF placebo capsule sibutramine IR/topiramate XR 15mg/75mg, taken once daily, taken once daily, for 52 weeks. | Drug | Experimental drug (Sibutramine IR 15mg / Topiramate XR 100mg) |
| SIB Group Sibus (Sibutramine) 15mgAlso: Sibutramine 15mgParticipant will receive for two (02) weeks one (01) 10mg sibutramine placebo capsule + one (01) 5mg/25mg sibutramine ADF placebo capsule IR/topiramate XR; after this initial period, they will receive for two (02) weeks one (01) 10mg sibutramine capsule + two (02) placebo capsules of ADF sibutramine IR/topiramate XR 5mg/25mg; after this 4-week period, participants will receive one (01) 10mg sibutramine capsule and three (03) ADF sibutramine IR/topiramate XR 5mg/25mg placebo capsules, taken once daily, for two (02) additional weeks. This corresponds to the titration scheme.On the treatment period, patient will receive one (01) Sibutramine 15mg capsule + one (01) Sibutramine IR/topiramate XR 15mg/75mg placebo capsule + one (01) placebo capsule of Topiramate XR 100mg, taken once daily, for 52 weeks. | Drug | Sibus (Sibutramine 15mg) |
| Placebo GroupAlso: Ef178 Placeboparticipants randomized to the Placebo Group will receive for two (02) weeks one (01) 10mg sibutramine placebo capsule + one (01) sibutramine IR/ topiramate XR 5mg/25mg placebo capsule; after this initial period, they will receive one (01) sibutramine 10mg placebo capsule + two (02) sibutramine IR/ topiramate XR 5mg/25mg placebo capsules, taken once daily, for two (02) weeks; after this 4-week period, participants will receive one (01) 10mg sibutramine placebo capsule + three (03) ADF placebo capsules, taken once daily, for two (02) weeks.On the treatment period, patient will receive one (01) Sibutramine 15mg placebo capsule + one (01) ADF sibutramine IR/Topiramate XR 15mg/75mg placebo capsule + one (01) Topiramate XR 100mg placebo capsule, in once daily intake for 52 weeks. | Drug | Placebo Group |
Primary outcome
Change in weight
Time frame: 58 weeks
The difference in mean percent body weight loss between the ADF sibutramine IR/topiramate XR group and the placebo-treated group is ≥5% in favor of ADF.
The mean percentage loss of body weight
Time frame: 58 weeks
The mean percentage loss of body weight in the ADF sibutramine IR/topiramate XR group was greater than that observed in the group treated with sibutramine IR
4 secondary outcomes
Proportion of participants with weight reduction ≥ 5%
Time frame: 58 weeks
Proportion of participants with weight reduction ≥ 10%
Time frame: 58 weeks
Proportion of participants with weight reduction ≥ 15%
Time frame: 58 weeks
Abdominal circumference
Time frame: 58 weeks
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 18 Dec 2025.
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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?
A Phase 3 study testing ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mg, ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mg and SIB Group Sibus (Sibutramine) 15mg in people with 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 24 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 18 Dec 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. Some participants in this study may receive a placebo. 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 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?
Change in weight (time frame: 58 weeks). The study lists 2 primary outcomes in all. 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 18 Dec 2025.