Actively Recruiting
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
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-02-07
537
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
B
BrightGene Bio-Medical Technology Co., Ltd.
Lead Sponsor
B
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of BGM0504 compared to semaglutide in people with type 2 diabetes who are already taking metformin and/or sulfonylureas. This phase 3 trial is conducted in China and sponsored by BrightGene Bio-Medical Technology Co., Ltd. The goal is to see how well these treatments control blood sugar levels and manage the condition. Participants receive one of three treatments: 5 mg or 10 mg of BGM0504, or 1 mg of semaglutide. All drugs are given as weekly injections under the skin. The trial includes a 32-week period to measure blood sugar changes, followed by further assessments up to 52 weeks to evaluate body weight, blood sugar control, and fasting glucose levels. During the study, participants will have regular visits for blood tests to measure hemoglobin A1c and fasting glucose, along with weight checks. Researchers will monitor safety and treatment effects throughout the study. The total participation time can last up to 52 weeks, with ongoing evaluations to understand how the treatments work over time.
CONDITIONS
Brief Title
A Study of BGM0504 in Participants with Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus (T2DM)
- Using stable-dose metformin (≥1500 mg/day) or maximum tolerated dose (≥1000 mg but <1500 mg daily) for at least 8 weeks before screening
- Using metformin at less than 1500 mg/day if not at maximum tolerated dose
- Using metformin combined with fixed-dose sulfonylureas at minimum therapeutic dose stable for at least 8 weeks
- Body mass index (BMI) of 23 kg/m² or higher at screening
- Stable weight (± 5%) for at least 3 months before screening
- Hemoglobin A1c (HbA1c) between 7.5% and 11.0%
You will not qualify if you...
- Previous diagnosis of type 1 diabetes or special type diabetes
- Malignant tumors within 5 years before screening or latent malignant tumors (except certain skin and in situ cancers with no recurrence)
- History of chronic or acute pancreatitis before study entry
- Known allergy to 3 or more foods or drugs, allergy to GLP-1 receptor agonists, or severe allergic diseases such as asthma or eczema
- Mentally incapacitated or speech-impaired
- History or suspicion of alcohol or drug abuse
- Pregnant or lactating women
- Any other condition deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive weekly injections of BGM0504 or Semaglutide as add-on therapy to their existing diabetes medication.
Weekly visits for up to 52 weeks
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
L
Linong Ji,MD, chief physician, Peking University People's Hospital
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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