A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients

A Phase 1, Single-Dose, Open-Label, Parallel-Group Pharmacokinetic Study of VCT220 in Subjects With Moderate Renal Impairment and Matched Subjects With Normal Renal Function

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.

Study Overview

• Status: Completed
• Conditions: Obesity & Overweight
• Intervention / Treatment: Drug: VCT220

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Subjects with Moderate Renal Impairment (absolute eGFR ≥30 and <60 mL/min)	Drug: VCT220; Single oral dose of VCT220 40 mg administered after a standardized breakfast.
Experimental: Group B; Subjects with Normal Renal Function Matched to Subjects with Moderate Renal Impairment (absolute eGFR ≥90 and <130 mL/min)	Drug: VCT220; Single oral dose of VCT220 40 mg administered after a standardized breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax) of VCT220	Day 1 at 0 h prior to dosing and at 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 h (Day 2) ,36.0 h(Day 2) , 48.0 h (Day 3), and 72.0 h (Day 4) after dosing
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC₀-t) of VCT220	Day 1 at 0 h prior to dosing and at 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 h (Day 2) ,36.0 h(Day 2) , 48.0 h (Day 3), and 72.0 h (Day 4) after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	From dosing through safety follow-up (Day 7 ± 3 days)

Collaborators and Investigators

• Sponsor: Vincentage Pharma Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2025
• Primary Completion (Actual): January 18, 2026
• Study Completion (Actual): February 18, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: VCT220-I-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No