A Study of BGM0504 in Chinese Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: BGM0504 Administered SC; Drug: Semaglutide Administered SC; Drug: Placebo Administered SC

• Registration Number: NCT06974825
• Lead Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of BGM0504 in Chinese patients with Type 2 Diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Status Verified: 2024-04
• Primary Completion: 2024-08-13
• Study Completion: 2024-08-13
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Have been diagnosed with type 2 diabetes mellitus (T2DM);
• Glycosylated hemoglobin (HbA1c) at screening/baseline: 7.0% ≤ HbA1c ≤ 10%;
• Body Mass Index (BMI): 19.5 kg/m2 ≤ BMI ≤ 35.0 kg/m2;
• Fasting blood glucose (FPG) at screening/baseline: FPG ≤ 13.3 mmoL/L

Exclusion Criteria

• Diagnosed with non-type 2 diabetes mellitus;
• Grade 3 hypoglycemia within 6 months prior to screening;
• Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose at screening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy;
• Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening;
• Patients with a previous history or clinical evidence of acute or chronic pancreatitis;
• Malignant tumor confirmed within 5 years prior to screening (except cured carcinoma in situ) or potential malignant tumor assessed at screening;
• Patients with severe mental illness or language disorder at screening, unwilling or unable to fully understand and cooperate;
• Female subjects during pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 mg BGM0504	BGM0504 Administered SC	-
10 mg BGM0504	BGM0504 Administered SC	-
15 mg BGM0504	BGM0504 Administered SC	-
1 mg Semaglutide	Semaglutide Administered SC	-
Placebo	Placebo Administered SC	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c)	Week 0 to Week 12	Change from baseline in HbA1c after 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Week 0 to Week 12	Change from baseline in body weight after 12 weeks of treatment.
Percentage of Participants With HbA1c Target Value of <7%	Week 0 to Week 12	Percentage of Participants With HbA1c Target Value of \<7% after 12 weeks of treatment.
Percentage of Participants With HbA1c Target Value of <6.5%	Week 0 to Week 12	Percentage of Participants With HbA1c Target Value of \<5.7% after 12 weeks of treatment.
Change From Baseline in Fasting Serum Glucose	Week 0 to Week 12	Change from baseline in FPG after 12 weeks of treatment.

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China