A Study of BGM0504 in Chinese Patients With Type 2 Diabetes

NCT06974825 | Completed Phase 2 FDA Drug

• 1 other identifier: BGM0504-IIa-T2DM
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c)

  Change from baseline in HbA1c after 12 weeks of treatment.

  Week 0 to Week 12

Secondary Outcomes (4)

• Change From Baseline in Body Weight

  Week 0 to Week 12

• Percentage of Participants With HbA1c Target Value of <7%

  Week 0 to Week 12

• Percentage of Participants With HbA1c Target Value of <6.5%

  Week 0 to Week 12

• Change From Baseline in Fasting Serum Glucose

  Week 0 to Week 12

Study Arms (5)

5 mg BGM0504

EXPERIMENTAL

Drug: BGM0504 Administered SC

10 mg BGM0504

EXPERIMENTAL

Drug: BGM0504 Administered SC

15 mg BGM0504

EXPERIMENTAL

Drug: BGM0504 Administered SC

1 mg Semaglutide

EXPERIMENTAL

Drug: Semaglutide Administered SC

Placebo

EXPERIMENTAL

Drug: Placebo Administered SC

Interventions

BGM0504 Administered SC DRUG

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

5 mg BGM0504

Semaglutide Administered SC DRUG

Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week

1 mg Semaglutide

Placebo Administered SC DRUG

Placebo Comparator: Placebo Placebo administered SC once a week.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BrightGene Bio-Medical Technology Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 16, 2025
• Study Start: August 30, 2023
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: May 16, 2025

Record last verified: 2024-04

Locations

CN (1)