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

NCT06938529 | Completed Phase 1 FDA Drug

• 1 other identifier: VCT220-I-05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax) of VCT220

  Predose up to 72 hours postdose (D1 to D4)

• Area Under the Serum Concentration Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of VCT220

  Predose up to 72 hours postdose (D1 to D4)

• Area Under the Serum Concentration Curve From Time 0 to Infinity(AUC0-inf) of VCT220

  Predose up to 72 hours postdose (D1 to D4)

Secondary Outcomes (1)

• Safety evaluation endpoints

  From Day 1 to Day 10

Study Arms (3)

Group A

EXPERIMENTAL

Subjects with mild hepatic impairment (Child-Pugh Class A, score of 5-6)

Drug: VCT220

Group B

EXPERIMENTAL

Subjects with moderate hepatic impairment (Child-Pugh Class B, score of 7-9)

Drug: VCT220

Group C

PLACEBO COMPARATOR

Subjects with normal hepatic function matched to hepatic impairment subjects

Drug: Placebo

Interventions

VCT220 DRUG

Small molecule GLP-1RA tablet, film coated

Group A; Group B

Placebo DRUG

VCT220 Placebo tablet

Group C

Eligibility Criteria

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

You may qualify if:

• Subjects must fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, sign a written informed consent form, and be able to complete the entire study process as required;
• Subjects must be between 18 and 75 years old (inclusive), of any sex;
• At screening, male subjects must weigh ≥50 kg and female subjects must weigh ≥45 kg, with a body mass index (BMI = weight (kg)/height² (m²)) between 18.5 and 35.0 kg/m² (inclusive);
• Subjects and their partners must agree to have no plans for pregnancy or sperm/egg donation from the signing of the informed consent form until 6 months after the last administration of the study drug, and must voluntarily use effective contraception.
• Subjects must have hepatic impairment caused by a primary liver disease, classified as Child-Pugh Class A (score 5-6) or Class B (score 7-9) at screening, and must not have used albumin within 14 days prior to screening. The hepatic impairment must be confirmed as stable (≥1 month) based on medical history, physical examination, laboratory tests, or imaging studies;
• Subjects must not have taken any medications within 1 week prior to screening, or, if long-term treatment for hepatic impairment and/or other comorbidities is necessary, must have been on a stable regimen for at least 4 weeks prior to screening (stable medication use to be determined by the investigator, excluding prohibited medications per protocol).

You may not qualify if:

• Known allergy to any component of the investigational drug, similar drugs (GLP-1 receptor agonists), or their excipients, a history of allergic constitution (multiple drug and food allergies), or a history of allergic diseases (such as asthma, urticaria, eczema, etc.);
• A history of hypoglycemia;
• Personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia syndrome (MEN2), or suspected MTC as judged by the investigator;
• A history of pancreatitis (chronic or acute pancreatitis);
• A history of malignant tumors or malignancy within the past 5 years (excluding stable liver cancer post-surgery for ≥2 years, treated and non-recurrent skin non-melanoma cancers, and removed cervical intraepithelial neoplasia);
• Severe infection, trauma, gastrointestinal surgery, or other major surgeries within the 4 weeks prior to screening;
• Clinically significant abnormalities on a 12-lead electrocardiogram (ECG), such as tachycardia/bradycardia requiring medication, second to third-degree atrioventricular block, QTcF interval prolongation (QTcF \>470 ms in males, \>480 ms in females) as per Fridericia's formula, or other clinically significant abnormalities as determined by the clinician;
• Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m², calculated using the Modification of Diet in Renal Disease (MDRD) formula;
• Hemoglobin A1c (HbA1c) \>6.5% at screening;
• Plans to undergo surgical treatment during the trial or a tendency to require hospitalization;
• Positive HIV antibody (HIV-Ab) test.
• Used enzyme inducers or inhibitors (strong and moderate inducers and inhibitors of CYP3A4, strong inducers and inhibitors of CYP2C8 and CYP2D6) within 4 weeks prior to dosing;
• Took any medication (including traditional Chinese medicine, vitamins, supplements) within 14 days prior to dosing (or 5 half-lives, whichever is longer), except for stable medication use in subjects with hepatic impairment;
• Participated in another clinical trial and received investigational drugs or medical devices within 1 month prior to screening, with the last dose date of the clinical study as the baseline (if the clinical trial drug has a long half-life, there should be at least a 5 half-life gap between this study and the previous one);
• Lost blood or donated ≥400 mL of blood within 3 months prior to dosing, or plans to donate blood within 1 month after the trial ends;

Sponsors & Collaborators

• Vincentage Pharma Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215006, 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: April 14, 2025
• First Posted: April 22, 2025
• Study Start: April 18, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 25, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)