Status:
COMPLETED
A Study of BGM0504 in Overweight or Obese Participants
Lead Sponsor:
BrightGene Bio-Medical Technology Co., Ltd.
Conditions:
Overweight or Obese
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the influence of BGM0504 injection on gastric emptying and Pharmacokinetics of metformin and warfarin in overweight or obese participants
Eligibility Criteria
Inclusion
- √ Have a body mass index (BMI) of greater than or equal to (≥)28 kilogram per square meter (kg/m²) or ≥24 kg/m2 and less than (\<) 28 kg/m².
- √ Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.
Exclusion
- √ History of chronic or acute pancreatitis.
- History of severe drug allergy or specific allergic disease or severe allergies.
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).
- History of malignant tumors \[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\].
- Suspected or confirmed history of alcohol or drug abuse;
- Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
- Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.
- Pregnant or lactating woman.
- Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
Key Trial Info
Start Date :
March 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06920056
Start Date
March 24 2025
End Date
July 25 2025
Last Update
September 9 2025
Active Locations (1)
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1
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan, China, 650100