Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated February 7, 2025 (before its estimated December 29, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-29.
Trial Details
NCT Number NCT06716203
Lead Sponsor BrightGene Bio-Medical Technology Co., Ltd.
Collaborators: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Conditions Type 2 Diabetes Mellitus (T2DM)
Enrollment 207 participants
Start Date 2024-12-02
Primary Completion 2025-12-29 (estimated)
Study Completion 2026-08-25 (estimated)
Updated on ClinicalTrials.gov 2025-02-07