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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Tirzepatide; Drug: BGM0504

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Linong Ji; Phone Number: +8613910978815; Email: jiln@bjmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Linong Ji; Phone Number: +8613910978815; Email: jiln@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGM0504; Participants will receive BGM0504 subcutaneously(SC).	Drug: BGM0504; Administered SC
Active Comparator: Tirzepatide; Paritcipants will receive tirzepatide SC.	Drug: Tirzepatide; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Body Weight	Change from baseline in body weight after 26 weeks of treatment	Week 0, Week 26

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): January 11, 2026
• Study Completion (Estimated): January 11, 2026

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: BGM0504-II -WL-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No