A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients

NCT ID: NCT07347808

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-25
• Study Completion Date: 2026-04-30

Brief Summary

This Phase 1 study is designed to evaluate the pharmacokinetics and safety of a single oral dose of VCT220 (other name: CX11) in subjects with moderate renal impairment compared with age-, sex-, and body mass index (BMI)-matched subjects with normal renal function. The results of this study will provide scientific evidence to support appropriate clinical dosing recommendations of VCT220 in subjects with renal impairment.

Detailed Description

This is a single-center, single-dose, open-label, non-randomized, parallel-group Phase 1 study. Subjects with moderate renal impairment (absolute estimated glomerular filtration rate [eGFR] ≥30 and <60 mL/min) and matched subjects with normal renal function (absolute eGFR ≥90 and <130 mL/min) will be enrolled.

Subjects will receive a single oral dose of VCT220 40 mg following a standardized breakfast. Pharmacokinetic blood samples will be collected up to 72 hours post-dose to characterize the plasma pharmacokinetics of VCT220 and its metabolite VCT289. Safety will be assessed through monitoring of adverse events, vital signs, physical examinations, laboratory tests, and electrocardiograms.

Conditions

Obesity & Overweight

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Subjects with Moderate Renal Impairment (absolute eGFR ≥30 and \<60 mL/min)

Group Type: EXPERIMENTAL

VCT220

Intervention Type: DRUG

Single oral dose of VCT220 40 mg administered after a standardized breakfast.

Group B

Subjects with Normal Renal Function Matched to Subjects with Moderate Renal Impairment (absolute eGFR ≥90 and \<130 mL/min)

Group Type: EXPERIMENTAL

VCT220

Intervention Type: DRUG

Single oral dose of VCT220 40 mg administered after a standardized breakfast.

Interventions

VCT220

Single oral dose of VCT220 40 mg administered after a standardized breakfast.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female subjects aged 18 to 75 years
• Body mass index (BMI) between 18.5 and 32.0 kg/m²
• Able and willing to provide written informed consent
• Willing to comply with contraception requirements
• Moderate renal impairment group
• Absolute eGFR ≥30 and <60 mL/min
• Diagnosis of chronic kidney disease for ≥3 months with stable renal function
• Normal renal function group:

Absolute eGFR ≥90 and <130 mL/min Matched to moderate renal impairment subjects by sex, age (±10 years), and BMI (±10%)

Exclusion Criteria

• History of hypersensitivity to GLP-1 receptor agonists or study drug components
• History of hypoglycemia
• History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
• History of pancreatitis
• Clinically significant cardiovascular, hepatic, gastrointestinal, neurological, hematologic, endocrine, or psychiatric disease
• Use of prohibited medications affecting drug metabolism prior to dosing
• Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
• Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vincentage Pharma Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Miles Zhang

Role: CONTACT

bd@vincentage.com

18210070401

Facility Contacts

Huan Zhou, PhD

Role: primary

1587621523@qq.com

0551-62923093

Other Identifiers

VCT220-I-08

Identifier Type: -

Identifier Source: org_study_id