A Study of BGM0504 in Participants With Obesity

NCT06911203 | Recruiting Phase 2 FDA Drug

• 1 other identifier: BGM0504-II -WL-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Body Weight

  Change from baseline in body weight after 26 weeks of treatment

  Week 0, Week 26

Secondary Outcomes (5)

• Change From Baseline in BMI

  Week 18, Week 26

• Change From Baseline in Waist Circumference

  Week 18, Week 26

• Change from Baseline in Systolic Blood Pressure (SBP)

  Week 18, Week 26

• Change from Baseline in Diastolic Blood Pressure (DBP)

  Week 18, Week 26

• Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)

  Week 0, Week 26

Study Arms (2)

BGM0504

EXPERIMENTAL

Participants will receive BGM0504 subcutaneously(SC).

Drug: BGM0504

Tirzepatide

ACTIVE COMPARATOR

Paritcipants will receive tirzepatide SC.

Drug: Tirzepatide

Interventions

BGM0504 DRUG

Administered SC

BGM0504

Tirzepatide DRUG

Administered SC

Tirzepatide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Central Study Contacts

Linong Ji

CONTACT

+8613910978815; jiln@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 4, 2025
• Study Start: April 3, 2025
• Primary Completion: January 11, 2026
• Study Completion: January 11, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-01

Locations

CN (1)