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A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight

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

NCT05209984•Eurofarma Laboratorios S.A.

View on ClinicalTrials.gov

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

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).

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female volunteers aged between 18 and 60 years (inclusive);
•2. 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);
•3. Women of childbearing age must use adequate contraceptive methods;
•4. Volunteers willing and able to comply with all aspects of the protocol;
•5. Signing the Informed Consent Form (ICF) before performing any study procedure.

Exclusion Criteria

•1. Participation in a lifestyle change program within the three months prior to the start of the study;
•2. 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;
•3. 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).
•4. Presence of diabetes mellitus;
•5. History of coronary artery disease (angina, history of myocardial infarction);
•6. Congestive heart failure;
•7. History of tachycardia;
•8. History of peripheral obstructive arterial disease;
•9. History of arrhythmia;
•10. History of cerebrovascular disease (stroke or transient ischemic attack);
+14 more criteria

Locations (2)

Eurofarma Laboratórios S.A

São Paulo, São Paulo, Brazil

HC-FMUSP

São Paulo, São Paulo, Brazil

Key Dates

Start Date

April 1, 2026

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

December 18, 2025

Conditions

OverweightObesity

Interventions

ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mg

DRUG

ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mg

DRUG

SIB Group Sibus (Sibutramine) 15mg

DRUG

Placebo Group

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight

Inclusion Criteria

Exclusion Criteria

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