A Study of BGM0504 in Chinese Patients With Type 2 Diabetes

NCT ID: NCT06974825

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-08-13

Brief Summary

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

5 mg BGM0504

Group Type: EXPERIMENTAL

BGM0504 Administered SC

Intervention Type: DRUG

5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

10 mg BGM0504

Group Type: EXPERIMENTAL

BGM0504 Administered SC

Intervention Type: DRUG

Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.

15 mg BGM0504

Group Type: EXPERIMENTAL

BGM0504 Administered SC

Intervention Type: DRUG

Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.

1 mg Semaglutide

Group Type: EXPERIMENTAL

Semaglutide Administered SC

Intervention Type: DRUG

Active Comparator: 1 mg Semaglutide

1 mg semaglutide administered SC once a week

Placebo

Group Type: EXPERIMENTAL

Placebo Administered SC

Intervention Type: DRUG

Placebo Comparator: Placebo Placebo administered SC once a week.

Interventions

BGM0504 Administered SC

5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Intervention Type: DRUG

BGM0504 Administered SC

Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.

Intervention Type: DRUG

BGM0504 Administered SC

Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.

Intervention Type: DRUG

Semaglutide Administered SC

Active Comparator: 1 mg Semaglutide

1 mg semaglutide administered SC once a week

Intervention Type: DRUG

Placebo Administered SC

Placebo Comparator: Placebo Placebo administered SC once a week.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrightGene Bio-Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

BGM0504-IIa-T2DM

Identifier Type: -

Identifier Source: org_study_id