AzTrials
AzTrials

Obesity, OverweightPhase 1NCT06938529

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

A Phase 1 study testing VCT220 in people with Obesity, Overweight, run by Vincentage Pharma Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
VCT220
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteChina
Study dates
18 Apr 2025to 25 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • For subjects with hepatic impairment, the following additional inclusion criteria must be met:
  • 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).

Who cannot join

  • 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;
Show all 40Show fewer
  • 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;
  • A smoker or has smoked more than 5 cigarettes daily in the 3 months prior to screening, or unable to stop tobacco product use during the study;
  • Currently or frequently consumes alcohol, i.e., females drinking more than 7 units of alcohol per week, males drinking more than 14 units of alcohol per week (1 unit = 285 mL beer, 25 mL of 40% alcohol, or 100 mL of wine); or testing positive for alcohol on a breathalyzer test at baseline, or unable to abstain from alcohol during the study;
  • Abused drugs or used soft drugs (e.g., cannabis) within 3 months prior to dosing, or used hard drugs (e.g., cocaine, amphetamines, piperazines) within 1 year prior to dosing, or tested positive for drug abuse on baseline urine screening;
  • Consumed grapefruit juice/grapefruit, methylxanthine-containing foods or drinks (tea, coffee, cola, chocolate, energy drinks), or other substances affecting drug absorption, distribution, metabolism, or excretion within 48 hours prior to dosing;
  • Unable to tolerate venipuncture or experiences fainting or anxiety with needles or blood;
  • Received a vaccination within 1 month prior to screening;
  • Pregnant or breastfeeding women, or tested positive for a blood pregnancy test;
  • The investigator considers the subject to have poor compliance, or other factors that make them unsuitable for participation in the study.
  • Additional exclusion criteria for subjects with liver dysfunction (exclude if any one condition is met):
  • Positive syphilis test result;
  • History of liver transplantation;
  • Drug-induced liver injury;
  • Acute liver injury caused by various reasons;
  • Cholestatic liver disease;
  • Liver failure with any of the following conditions: Uncontrollable infection; Grade 3/4 hepatic encephalopathy;
  • Severe complications of cirrhosis with any of the following conditions: Active bleeding from esophageal or gastric varices; Severe/late-stage ascites or pleural effusion requiring puncture, drainage, and albumin supplementation; Hepatorenal syndrome subjects, or those deemed unsuitable for participation in the study by the investigator;
  • Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg), heart rate >120 bpm (allowing for two re-tests);
  • History of any serious illness other than the primary liver disease itself, or a history or clinical laboratory abnormalities (including but not limited to circulatory, endocrine, neurological, digestive, urinary, hematologic, immune, psychiatric, and metabolic diseases) that may affect the study results, as determined by the investigator;
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >5 times the upper limit of normal (ULN) during the screening period.
  • Additional exclusion criteria for subjects with normal liver function (exclude if any one condition is met):
  • Positive test result for Treponema pallidum (TP) antibody;
  • History of significant primary organ disease, including but not limited to neurological, psychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, or immune diseases, as judged by the investigator to be unsuitable for participation in this trial;
  • History of liver dysfunction or abnormal screening results (including physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, 12-lead ECG, chest X-ray, abdominal ultrasound, etc.) deemed clinically significant by the investigator;
  • Age outside of the mean ±10 years for subjects with mild/moderate liver dysfunction, and/or BMI outside of the ±10% of the mean BMI for subjects with mild/moderate liver dysfunction;
  • Positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody during the screening period.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

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

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.

Being tested
VCT220, Placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VCT220Drug

    Small molecule GLP-1RA tablet, film coated

  • PlaceboDrug

    VCT220 Placebo tablet

Study groups in NCT06938529
Study groupRoleWhat they receive
Group AExperimentalSubjects with mild hepatic impairment (Child-Pugh Class A, score of 5-6)
Receives: Drug: VCT220
Group BExperimentalSubjects with moderate hepatic impairment (Child-Pugh Class B, score of 7-9)
Receives: Drug: VCT220
Group CPlacebo comparatorSubjects with normal hepatic function matched to hepatic impairment subjects
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Plasma Concentration (Cmax) of VCT220

    Measured: Predose up to 72 hours postdose (D1 to D4)

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

    Measured: Predose up to 72 hours postdose (D1 to D4)

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

    Measured: Predose up to 72 hours postdose (D1 to D4)

Secondary outcomes (1)

  1. Safety evaluation endpoints

    Including the incidence and severity of AEs and SAEs.

    Measured: From Day 1 to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2025
  2. Study start18 Apr 2025
  3. Primary completion15 Jul 2025
  4. Study completion25 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06938529
Sponsor's protocol ID
VCT220-I-05
Status last verified
Aug 2025
First submitted
14 Apr 2025
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VCT220 in people with Obesity, Overweight, run by Vincentage Pharma Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) of VCT220 (time frame: Predose up to 72 hours postdose (D1 to D4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06938529.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in