A Study of BGM0504 in Overweight or Obese Participants

Launched by BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is evaluating a new injection called BGM0504 to see how it affects the way food leaves the stomach and how certain medications, like metformin and warfarin, work in overweight or obese individuals. The study is currently looking for participants aged between 65 and 74 years old who have a body mass index (BMI) of 28 or higher, or a BMI between 24 and 28 if they meet other criteria. Participants must be willing to follow the study's requirements and undergo various procedures as instructed by the clinic staff.

If you decide to participate, you can expect to receive the injection and undergo several assessments during the study. However, some individuals may not be eligible to join due to specific health conditions, such as a history of pancreatitis or certain types of cancer, as well as those who are pregnant or breastfeeding. It's important to know that the trial aims to ensure the safety of all participants, so those with certain medical histories may be excluded. Overall, this study is an opportunity to contribute to research that could help improve treatments for overweight and obese individuals.

Gender

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Eligibility criteria

• • Inclusion Criteria: √ 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 Criteria: √ 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.