Actively Recruiting
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
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-02-07
207
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 effects of BGM0504 in Chinese patients with type 2 diabetes who have poor blood sugar control managed only by diet and exercise. This phase III clinical trial aims to assess the benefits and safety of BGM0504 injections over 32 weeks compared to a placebo, with extended monitoring for up to 52 weeks to evaluate longer-term effects. Participants receive weekly subcutaneous injections of either 5 mg or 10 mg of BGM0504, or a placebo, in a randomized and double-blind manner. The study includes a main treatment period of 32 weeks, during which the primary outcome of blood sugar control (measured by hemoglobin A1c) is evaluated, followed by continued treatment and assessment up to 52 weeks for additional safety and efficacy measures. During the trial, participants will undergo regular assessments including blood tests to measure hemoglobin A1c, fasting glucose, and body weight. These evaluations occur at specified intervals to monitor changes from baseline. Safety and treatment adherence will also be closely followed throughout the study period, which lasts up to 52 weeks for each participant.
CONDITIONS
Brief Title
A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus (T2DM)
- Body mass index (BMI) of 23 kg/m² or higher at screening
- Stable weight within ±5% for at least 3 months before screening
- Hemoglobin A1c between 7.5% and 11.0%
- Fasting plasma glucose (FPG) of 15.0 mmol/L or less
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/clinical malignant tumors (except certain skin, cervical, prostate, or thyroid cancers without recurrence after surgery)
- History of chronic or acute pancreatitis prior to study entry
- Known allergies to 3 or more foods or drugs, allergy to GLP-1 receptor agonists, or severe allergic diseases at screening
- Mentally incapacitated or speech-impaired
- Suspected or confirmed history of alcohol or drug abuse
- Pregnant or lactating women
- Any other conditions 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.
Duration - 32 weeks
Participants receive either 5 mg or 10 mg of BGM0504 or placebo administered subcutaneously once a week.
Weekly visits for up to 32 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
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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