A Study of BGM0504 in Participants with Type 2 Diabetes

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Drug: 5 mg BGM0504 Administered SC; Drug: Drug:10 mg BGM0504 Administered SC; Drug: Drug: Semaglutide Administered SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06716216

BGM0504-Ⅲ -T2DM-02

Details and patient eligibility

About

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

Enrollment: 537 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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537 participants in 3 patient groups

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

Experimental group

Description:

Drug: BGM0504 Administered SC

Treatment:

Drug: Drug: 5 mg BGM0504 Administered SC

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

Experimental group

Description:

Drug: BGM0504 Administered SC

Treatment:

Drug: Drug:10 mg BGM0504 Administered SC

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

Active Comparator group

Description:

Drug: Semaglutide Administered SC

Treatment:

Drug: Drug: Semaglutide Administered SC