A Study of BGM0504 in Participants With Obesity

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 2

Conditions: Obesity

Treatments: Drug: BGM0504; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06911203

BGM0504-II -WL-02

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

BGM0504

Experimental group

Description:

Participants will receive BGM0504 subcutaneously(SC).

Treatment:

Drug: BGM0504

Tirzepatide

Active Comparator group

Description:

Paritcipants will receive tirzepatide SC.

Treatment:

Drug: Tirzepatide