Status:
RECRUITING
A Study of BGM0504 in Participants With Obesity
Lead Sponsor:
BrightGene Bio-Medical Technology Co., Ltd.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.
Eligibility Criteria
Inclusion
- ● Able and willing to provide a written informed consent.
- Male or female subjects, 18-65 years of age at the time of signing informed consent.
- At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;
- Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.
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 :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 11 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06911203
Start Date
April 3 2025
End Date
January 11 2026
Last Update
October 28 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044