NCT06716216

A Study of BGM0504 in Participants with Type 2 Diabetes

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly As Add-on Therapy to Metformin And/or Sulfonylureas in Patients with Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 537 (estimated)
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Drug: 5 mg BGM0504 Administered SC	Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
DRUG	Drug:10 mg BGM0504 Administered SC	Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.
DRUG	Drug: Semaglutide Administered SC	Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week

Timeline

• Start date: 2024-11-29
• Primary completion: 2026-03-20
• Completion: 2026-11-14
• First posted: 2024-12-04
• Last updated: 2025-02-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study