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

NCT05209984 | Withdrawn Phase 3

• 1 other identifier: EF178
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  58 weeks

Secondary Outcomes (4)

• Proportion of participants with weight reduction ≥ 5%

  58 weeks

• Proportion of participants with weight reduction ≥ 10%

  58 weeks

• Proportion of participants with weight reduction ≥ 15%

  58 weeks

• Abdominal circumference

  58 weeks

Study Arms (4)

Experimental drug (Sibutramine IR 15mg / Topiramate XR 75mg)

EXPERIMENTAL

ADF1 Group Eurofarma drug association of sibutramine IR 15mg / topiramate XR 75mg

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..

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

Sibus (Sibutramine 15mg)

ACTIVE COMPARATOR

SIB Group Sibutramine 15mg

Drug: SIB Group Sibus (Sibutramine) 15mg

Placebo Group

PLACEBO COMPARATOR

Placebo Group

Drug: Placebo Group

Interventions

Placebo Group DRUG

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.

Also known as: Ef178 Placebo

Placebo Group

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

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.

Also known as: EF178 15/100mg

Experimental drug (Sibutramine IR 15mg / Topiramate XR 100mg)

SIB Group Sibus (Sibutramine) 15mg DRUG

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.

Also known as: Sibutramine 15mg

Sibus (Sibutramine 15mg)

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

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.

Also known as: EF178 15/75mg

Experimental drug (Sibutramine IR 15mg / Topiramate XR 75mg)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (2)

Eurofarma Laboratórios S.A

São Paulo, São Paulo, 06696-000, Brazil

Location

HC-FMUSP

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

sibutramine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-02

Locations

BR (2)