Actively Recruiting
A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-12-19
60
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
B
BrightGene Bio-Medical Technology Co., Ltd.
Lead Sponsor
B
BrightGene Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.
CONDITIONS
Official Title
A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants
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 males weighing at least 50 kg and females weighing at least 45 kg
- Body mass index (BMI) between 20.0 and less than 24.0 kg/m² for healthy subjects
- BMI of 28.0 kg/m² or higher for obese individuals, or BMI between 24.0 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 signed informed consent
- Willing and able to comply with study schedule, requirements, and restrictions
- Male subjects with female partners of reproductive potential must agree to use effective contraception during the study and for at least 3 months after dosing and refrain from sperm donation for at least 3 months post dose
You will not qualify if you...
- History of severe drug allergies or severe specific allergic diseases, or severe allergic constitution
- Positive test results for HBsAg, anti-HCV, anti-HIV, or anti-TP during screening
- Abnormal heart rate or rhythm as shown by 12-lead ECG at screening or baseline, including ventricular heart rate less than 50 or greater than 100 beats/min, second or third degree atrioventricular block, long QT syndrome, QTcF over 470 ms for women or over 450 ms for men, pre-excitation syndrome, or other significant arrhythmias
- Use of illegal drugs within 6 months prior to screening or substance abuse within 12 months prior to screening
- Participation in other drug or medical device clinical trials with active treatment within 12 weeks before screening
- Receipt of any vaccine within 2 weeks prior to screening or planned vaccination during the trial
- Female participants who are pregnant, lactating, or with a positive pregnancy test during screening
- Positive urine drug test or alcohol serum test at screening or baseline
- Any other conditions or disorders that the Investigator considers unsuitable for study participation
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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