A Study of BGM0504 in Participants With Obesity

Recruiting now · Phase 2

Conditions studied: Obesity

In brief

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

Key facts

Study ID

NCT06911203

Run by

BrightGene Bio-Medical Technology Co., Ltd.

People needed

90

Starts

2025-04-03

Expected to finish

2026-01-11

Last updated by the study team

2025-10-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ● 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.

You may not qualify if…

• ●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.

Where it is running

• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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