Trial · NCT05209984
A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight
NCT05209984, Phase 3, Withdrawn, Eurofarma Laboratorios S.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight. Trials, record NCT05209984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05209984
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight
- NCT number
- NCT05209984
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Conditions
- Overweight, Obesity
- Interventions
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
- First posted
- 2022-01-27
- Last updated
- 2025-12-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in weight | 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. |
| Primary | The mean percentage loss of body weight | 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 |
| Secondary | Proportion of participants with weight reduction ≥ 5% | 58 weeks | Proportion of participants with weight reduction ≥ 5% at the end of treatment in relation to baseline weight; |
| Secondary | Proportion of participants with weight reduction ≥ 10% | 58 weeks | Proportion of participants with weight reduction ≥ 10% at the end of treatment in relation to baseline weight |
| Secondary | Proportion of participants with weight reduction ≥ 15% | 58 weeks | Proportion of participants with weight reduction ≥ 15% at the end of treatment in relation to baseline weight; |
| Secondary | Abdominal circumference | 58 weeks | The measurement of abdominal circumference |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05209984
GET https://conductscience.org/api/trials/v1/NCT05209984/registered