NCT06714955

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult Subjects

A Phase 1, Double-Blind, Parallel-arm, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection Administered Subcutaneously in Non-diabetic Overweight or Obese Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, double-blind, parallel-arm ,placebo-controlled study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), safety and tolerability of BGM0504 following multiple subcutaneous (SC) administrations in non-diabetic overweight or obese adult subjects.

Conditions

• Non-diabetic Overweight or Obese

Interventions

Type	Name	Description
DRUG	Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.	Drug: BGM0504 Administered SC
DRUG	Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.	Drug: BGM0504 Administered SC
DRUG	Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.	Drug: Placebo Administered SC

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-01-21
• Completion: 2025-03-03
• First posted: 2024-12-04
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study