A Study of BGM0504 in Participants with Type 2 Diabetes

NCT ID: NCT06716216

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 537 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-29
• Study Completion Date: 2026-11-14

Brief Summary

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Drug: BGM0504 Administered SC

Group Type: EXPERIMENTAL

Drug: 5 mg BGM0504 Administered SC

Intervention Type: DRUG

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

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

Drug: BGM0504 Administered SC

Group Type: EXPERIMENTAL

Drug:10 mg BGM0504 Administered SC

Intervention Type: DRUG

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

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

Drug: Semaglutide Administered SC

Group Type: ACTIVE_COMPARATOR

Drug: Semaglutide Administered SC

Intervention Type: DRUG

Active Comparator: 1 mg Semaglutide

1 mg semaglutide administered SC once a week

Interventions

Drug: 5 mg BGM0504 Administered SC

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

Intervention Type: DRUG

Drug:10 mg BGM0504 Administered SC

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

Intervention Type: DRUG

Drug: Semaglutide Administered SC

Active Comparator: 1 mg Semaglutide

1 mg semaglutide administered SC once a week

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ■ Have been diagnosed with type 2 diabetes mellitus (T2DM);

• Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg/day) or maximum tolerated (< 1500mg but≥1000mg daily) for 8 weeks before screening； 2)Metformin treatment dose <1500mg/day at Screening and have not reached the maximum tolerated dose ；3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.
• Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
• Be of stable weight (± 5%) for at least 3 months before screening;
• Have HbA1c between ≥7.5% and ≤11.0%；

Exclusion Criteria

• ■ Previous diagnosis of type 1 diabetes, special type diabetes;

• There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
• Have had chronic or acute pancreatitis any time prior to study entry;
• Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
• Mentally incapacitated or speech-impaired;
• Suspected or confirmed history of alcohol or drug abuse;
• Pregnant or lactating woman;
• The investigator considers that there are any other conditions that make it inappropriate to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

INDUSTRY

Sponsor Role: collaborator

BrightGene Bio-Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Linong Ji,MD, chief physician, Peking University People's Hospital

Role: CONTACT

jiln@bjmu.edu.cn

+86 13910978815

Facility Contacts

Linong Ji

Role: primary

jiln@bjmu.edu.cn

+8613910978815

Other Identifiers

BGM0504-Ⅲ -T2DM-02

Identifier Type: -

Identifier Source: org_study_id