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

ClinicalTrials7 Feb 2025·Phase 3● 5/10i

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

BrightGene Bio-Medical Technology Co., Ltd.

BGM0504, a once-weekly injection from BrightGene Bio-Medical, is being tested against semaglutide as add-on therapy to metformin and/or sulfonylureas in adults with type 2 diabetes. The open-label phase 3 trial enrolls 537 participants in China with expected completion in March 2026. This represents a direct challenge to Novo Nordisk's Ozempic franchise in the Chinese market from a domestic biosimilar competitor. The head-to-head design against branded semaglutide signals BrightGene's confidence in demonstrating non-inferiority for regulatory approval and market access positioning.

Strategic signal

BrightGene's head-to-head trial against Ozempic positions BGM0504 for Chinese regulatory approval with direct efficacy comparisons, potentially enabling competitive pricing against Novo Nordisk. China's centralized procurement system favors domestic biosimilars with demonstrated non-inferiority, creating formulary access advantages. This follows the established pathway of Chinese GLP-1 biosimilars using semaglutide comparator trials to secure NMPA approval and healthcare reimbursement. The March 2026 completion timing aligns with China's next procurement cycle evaluation period.

GLP-1Type 2 diabetesDrug comparisonsBrightGene Bio-Medical Technology Co., Ltd.Novo Nordisk

Original Abstract

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 | Condition(s): Type 2 Diabetes Mellitus (T2DM) | Primary endpoint(s): Change From Baseline in Hemoglobin A1c (HbA1c) | Enrollment: 537 (estimated) | Phase: Phase 3 | Sponsor: BrightGene Bio-Medical Technology Co., Ltd. | Expected completion: 2026-03-20 | Status: Recruiting | Last update: 2025-02-07

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