Evaluating BGM0504 for Type 2 Diabetes Management

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly As Add-on Therapy to Metformin And/or Sulfonylureas in Patients with Type 2 Diabetes

This study is testing a new diabetes medication called BGM0504 to see if it works better than semaglutide for people with type 2 diabetes who are already taking other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 537 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06716216 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the efficacy and safety of BGM0504 compared to semaglutide when used alongside metformin and/or sulfonylureas in patients with type 2 diabetes mellitus. Conducted in China, the study involves administering BGM0504 at two different doses via subcutaneous injection. Participants will be monitored for changes in their diabetes management and overall health outcomes. The trial is designed to provide insights into a new treatment option for individuals struggling to control their blood sugar levels.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with type 2 diabetes who are currently on stable doses of metformin and/or sulfonylureas.

Not a fit: Patients with type 1 diabetes or those with recent malignant tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for managing type 2 diabetes, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific efficacy of BGM0504 is still being evaluated.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Linong Ji,MD, chief physician, Peking University People's Hospital

Conditions Type 2 Diabetes Mellitus