NCT06929156

A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function

A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of BGM0504 Injection in Healthy Participants and Participants With Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess how fast BGM0504 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• Overweight or Obese

Interventions

Type	Name	Description
DRUG	BGM0504	Receive a single dose of BGM0504 injection
DRUG	BGM0504	Receive a single dose of BGM0504 injection
DRUG	BGM0504	Receive a single dose of BGM0504 injection
DRUG	BGM0504	Receive a single dose of BGM0504 injection

Timeline

• Start date: 2025-05-06
• Primary completion: 2025-12-25
• Completion: 2025-12-25
• First posted: 2025-04-16
• Last updated: 2026-02-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study