A Study of BGM0504 in Participants With Obesity

Phase 2

Recruiting

• Conditions: Obesity
• Interventions: Drug: BGM0504; Drug: Tirzepatide

• Registration Number: NCT06911203
• Lead Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-08
• Primary Completion: 2026-01-11
• Study Completion: 2026-01-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BGM0504	BGM0504	Participants will receive BGM0504 subcutaneously(SC).
Tirzepatide	Tirzepatide	Paritcipants will receive tirzepatide SC.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Week 0, Week 26	Change from baseline in body weight after 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in BMI	Week 18, Week 26	Change from baseline in BMI after 26 weeks of treatment
Change From Baseline in Waist Circumference	Week 18, Week 26	Change from baseline in waist circumference after 26 weeks of treatment
Change from Baseline in Systolic Blood Pressure (SBP)	Week 18, Week 26	Change from Baseline in SBP after 26 weeks of treatment
Change from Baseline in Diastolic Blood Pressure (DBP)	Week 18, Week 26	Change from Baseline in DBP after 26 weeks of treatment
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)	Week 0, Week 26	Change from Baseline in IWQOL-Lite-CT after 26 weeks of treatment

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China