A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients

NCT07347808 | Completed Phase 1 FDA Drug

• 1 other identifier: VCT220-I-08
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From dosing through safety follow-up (Day 7 ± 3 days)

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: VCT220

Group B

EXPERIMENTAL

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

Drug: VCT220

Interventions

VCT220 DRUG

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vincentage Pharma Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 16, 2026
• Study Start: December 25, 2025
• Primary Completion: January 18, 2026
• Study Completion: February 18, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)