NCT06098079

Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)

A Phase IV Study to Assess the Effect of Naltrexone Hydrochloride Extended Release (ER) and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on the Occurrence of Major Adverse Cardiovascular Events

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8,600 (estimated)
• Sponsor: Currax Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB).

Detailed description

This multi-center, prospective, randomized, pragmatic, double-blinded study has been designed to capture cardiovascular (CV) outcomes during the real-world use of NB after initial randomization. The aim of the study is to assess whether patients receiving treatment with NB are at an elevated risk of experiencing MACE compared with patients receiving placebo. Both patient groups will also be counselled to lose weight via a reduced-calorie diet and increased physical activity.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Naltrexone-Bupropion (NB) Combination	A total daily dosage of two NB 8 mg/90 mg tablets twice daily (32 mg/360 mg) is reached at the start of Week 4.
DRUG	Placebo	A total daily dosage of two placebo tablets twice daily (in an identical, non-medicine containing tablet) is reached at the start of Week 4.

Timeline

• Start date: 2024-01-03
• Primary completion: 2029-01-01
• Completion: 2029-07-01
• First posted: 2023-10-24
• Last updated: 2026-03-31

Locations

140 sites across 1 country: United States

Regulatory

• FDA-regulated drug study