Actively Recruiting
A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-02-07
207
Participants Needed
1
Research Sites
90 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
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise. The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
CONDITIONS
Official 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 (± 5%) for at least 3 months before screening
- Hemoglobin A1c (HbA1c) 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 with no 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
- History or suspicion of alcohol or drug abuse
- Pregnant or lactating women
- Any other conditions deemed inappropriate for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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