NCT06716203

A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (estimated)
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise. The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Drug: 5 mg BGM0504 Administered SC	Drug: BGM0504 Administered SC
DRUG	Drug: : 10 mg BGM0504 Administered SC	Drug: BGM0504 Administered SC
DRUG	Drug: Placebo Administered SC	Drug: Placebo Administered SC

Timeline

• Start date: 2024-12-02
• Primary completion: 2025-12-29
• Completion: 2026-08-25
• First posted: 2024-12-04
• Last updated: 2025-02-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study