Overview
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
Inclusion Criteria:
- ● 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 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.