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A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Sponsor: BrightGene Bio-Medical Technology Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
207
Start Date
2024-12-02
Completion Date
2026-08-25
Last Updated
2025-02-07
Healthy Volunteers
No
Conditions
Interventions
Drug: 5 mg BGM0504 Administered SC
Drug: BGM0504 Administered SC
Drug: : 10 mg BGM0504 Administered SC
Drug: BGM0504 Administered SC
Drug: Placebo Administered SC
Drug: Placebo Administered SC
Locations (1)
Peking University People's Hospital
Beijing, Beijing Municipality, China