drugset / Trial / NCT06716203
A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Phase 3
Recruiting
207 enrolled
BrightGene Bio-Medical Technology Co., Ltd.
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd. · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2024-12-02
- Primary completion
- 2025-12-29
- Completion
- 2026-08-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BGM0504 | Unknown | 5 mg | Subcutaneous |
| Subject | BGM0504 | Unknown | 10 mg | Subcutaneous |