A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
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…
Conditions studied
Type 2 Diabetes Mellitus (T2DM)
About this study
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.
Interventions
- 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
Primary outcomes
- Change From Baseline in Hemoglobin A1c (HbA1c) (Week 0 to Week 32)
Eligibility information
Study locations
- Peking University People's Hospital, Beijing, Beijing Municipality 100044 China
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.