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

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

• Overweight
• Obesity

Interventions

DRUG

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

DRUG

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

DRUG

SIB Group Sibus (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.

DRUG

Placebo Group

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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2028-03-31

Completion

2028-03-31

Countries

• Brazil

Study Locations