Evaluating BGM0504 for treating 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

This study is testing a new treatment called BGM0504 to see if it can help adults with obesity lose weight and improve their health compared to a current medication.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06911203 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of BGM0504 compared to Tirzepatide in adults with obesity who do not have diabetes. Participants will undergo treatment for 26 weeks, during which their weight and health outcomes will be monitored. The study focuses on individuals with a specific BMI range and requires them to have maintained a stable weight prior to enrollment. The goal is to determine if BGM0504 can provide a beneficial alternative to existing obesity treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a BMI between 35.0 and 45.0 kg/m2 who have maintained a stable weight.

Not a fit: Patients with a history of certain cancers, pancreatitis, or severe allergies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for managing obesity in patients without diabetes.

How similar studies have performed: Other studies have shown promise with similar obesity treatments, indicating potential for success with this approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Linong Ji

Conditions: Obesity