NCT06974825

A Study of BGM0504 in Chinese Patients With Type 2 Diabetes

A Randomized, Double-blind, Placebo and Positive Drug Parallel-controlled Phase IIa Clinical Study Protocol to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Multiple-dose BGM0504 Injection in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of BGM0504 in Chinese patients with Type 2 Diabetes.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	BGM0504 Administered SC	5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
DRUG	BGM0504 Administered SC	Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.
DRUG	BGM0504 Administered SC	Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.
DRUG	Semaglutide Administered SC	Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week
DRUG	Placebo Administered SC	Placebo Comparator: Placebo Placebo administered SC once a week.

Timeline

• Start date: 2023-08-30
• Primary completion: 2024-08-13
• Completion: 2024-08-13
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study