NCT07382908

Bioequivalence Study of BGM0504 Injection

A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).

Conditions

• Overweight/Obesity

Interventions

Type	Name	Description
DRUG	BGM0504 Injection multi-dose pen	5 mg, single subcutaneous injection in the abdominal region
DRUG	BGM0504 Injection single-dose pen	5 mg, single subcutaneous injection in the abdominal region
DRUG	BGM0504 Injection single-dose pen	5 mg, single subcutaneous injection in the abdominal region

Timeline

• Start date: 2025-12-23
• Primary completion: 2026-02-12
• Completion: 2026-02-12
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study