NCT06938529

A Pharmacokinetic Study of VCT220 in Particicants With Hepatic Injury and Normal Hepatic Function

A Phase I Pharmacokinetic Study of VCT220 in Subjects With Varying Degrees of Hepatic Impairment and Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Vincentage Pharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, non-randomized study to assess how VCT220 is absorbed, distributed, metabolized, and eliminated after a single oral dose. The study includes three groups: subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), and healthy subjects matched by gender, age, and body mass index (BMI). It will also explore the relationship between baseline liver function measures and the pharmacokinetic (PK) parameters of VCT220, to support appropriate dosing recommendations for patients with liver impairment.

Conditions

• Obesity, Overweight

Interventions

Type	Name	Description
DRUG	VCT220	Small molecule GLP-1RA tablet, film coated
DRUG	Placebo	VCT220 Placebo tablet

Timeline

• Start date: 2025-04-18
• Primary completion: 2025-07-15
• Completion: 2025-07-25
• First posted: 2025-04-22
• Last updated: 2025-08-14

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study