Actively Recruiting
A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-11-20
75
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.
CONDITIONS
Official Title
A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18 and 65 years (inclusive) at the time of screening, healthy and non-diabetic overweight or obese subjects, both male and female
- Healthy male subjects must weigh at least 50 kg; healthy female subjects must weigh at least 45 kg
- Body mass index (BMI) between 20.0 kg/m² and less than 28 kg/m² for healthy subjects
- BMI of 28.0 kg/m² or higher for obese individuals, or BMI between 24.0 kg/m² and less than 28.0 kg/m² for overweight individuals
- Stable body weight with less than 5% self-reported change during the previous 12 weeks before screening
- No history of mental disorders and able to communicate smoothly with the Investigator
- Capable of understanding and willing to provide valid, signed written informed consent
- Willing and able to comply with the study schedule, requirements, and restrictions
- Male subjects with female partners of reproductive potential must agree to practice abstinence or use condoms plus an additional medically acceptable form of contraception during the study and for at least 3 months after dosing
- Male subjects must agree to refrain from sperm donation for at least 3 months post dose
You will not qualify if you...
- History of severe drug allergies, especially to BGM0504 tablets or their ingredients, or severe allergic diseases or constitution
- Positive tests for HBsAg, anti-HCV, anti-HIV, or anti-TP during screening
- Laboratory test abnormalities at screening/baseline including:
- Fasting serum glucose ≥ 7.0 mmol/L or post-prandial glucose (PPG)-2h ≥ 11.1 mmol/L in oral glucose tolerance test
- ALT or AST ≥ 2.5 times upper limit of normal or total bilirubin ≥ 1.5 times upper limit of normal
- Glomerular filtration rate ≤ 80 mL/min/1.73 m² or urine protein 2+ or more
- Serum calcitonin level ≥ 35 ng/L
- Thyroid-stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L
- Fasting triglycerides ≥ 5.64 mmol/L
- Hemoglobin < 100 g/L for females or < 110 g/L for males
- ECG showing abnormal heart rates or arrhythmias at screening/baseline
- Use of illegal drugs within 6 months or substance abuse within 12 months prior to screening
- Participation in drug or device clinical trials with study drug or device within 12 weeks before screening
- Received any vaccine within 2 weeks prior to screening or planned vaccination during the trial
- Female participants who are pregnant, lactating, or have a positive pregnancy test during screening
- Positive urine drug or alcohol test at screening or baseline
- Other conditions deemed unsuitable 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
The First Affiliated Hospital of Yunnan University of Chinese Medicine
Kunming, Yunnan, China, 650000
Actively Recruiting
Research Team
J
Jianchang He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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