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RECRUITINGPhase 2INTERVENTIONAL

A Study of BGM0504 in Participants With Obesity

A Phase II, Randomized Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BGM0504 Compared to Tirzepatide in Adults Who Have Obesity

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.

Who May Be Eligible (Plain English)

Who May Qualify: - ● Able and willing to provide a written willing to sign a consent form. - Male or female subjects, 18-65 years of age at the time of signing willing to sign a consent form. - 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. Who Should NOT Join This Trial: - ●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 weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

BGM0504

Administered SC

DRUG

Tirzepatide

Administered SC

Locations (1)

Peking University People's Hospital
Beijing, Beijing Municipality, China