Evaluating BGM0504 for Type 2 Diabetes Management
A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone
This study is testing a new injection called BGM0504 to see if it can help Chinese patients with poorly controlled type 2 diabetes who only manage their condition with diet and exercise.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 207 (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 | NCT06716203 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled phase III clinical study aims to assess the efficacy and safety of BGM0504 in patients with poorly controlled type 2 diabetes who manage their condition solely through diet and exercise. Participants will receive either BGM0504 injections or a placebo over a 32-week period, with an additional evaluation of efficacy and safety over 52 weeks. The study focuses on Chinese patients with specific inclusion criteria related to their diabetes management and health status.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults diagnosed with type 2 diabetes, having a BMI of 23 or higher and specific HbA1c levels.
Not a fit: Patients with type 1 diabetes, certain malignancies, or severe allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing type 2 diabetes in patients who struggle with glycemic control through lifestyle changes alone.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment is being evaluated in a novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ☑ Have been diagnosed with type 2 diabetes mellitus (T2DM); * 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%； * Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L. 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
- Email: jiln@bjmu.edu.cn
- Phone: +86 13910978815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.