A Study of BGM0504 in Chinese Patients With Type 2 Diabetes

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Semaglutide Administered SC; Drug: Placebo Administered SC; Drug: BGM0504 Administered SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06974825

BGM0504-IIa-T2DM

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 5 patient groups

5 mg BGM0504

Experimental group

Treatment:

Drug: BGM0504 Administered SC

Drug: BGM0504 Administered SC

Drug: BGM0504 Administered SC

10 mg BGM0504

Experimental group

Treatment:

Drug: BGM0504 Administered SC

Drug: BGM0504 Administered SC

Drug: BGM0504 Administered SC

15 mg BGM0504

Experimental group

Treatment:

Drug: BGM0504 Administered SC

Drug: BGM0504 Administered SC

Drug: BGM0504 Administered SC

1 mg Semaglutide

Experimental group

Treatment:

Drug: Semaglutide Administered SC

Placebo

Experimental group

Treatment:

Drug: Placebo Administered SC