Obesity & OverweightPhase 1NCT07347808
A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients
A Phase 1 study testing VCT220 in people with Obesity & Overweight, run by Vincentage Pharma Co., Ltd at 1 site in China.
Trial 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. 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?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 18 Feb 2026
- 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
- 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
Show all 9Show fewer
- 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%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
About this study
Official title: 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.
Read the 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
- Being tested
- VCT220
- 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
Single oral dose of VCT220 40 mg administered after a standardized breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects with Moderate Renal Impairment (absolute eGFR ≥30 and <60 mL/min) Receives: Drug: VCT220 |
| Group B | Experimental | Subjects with Normal Renal Function Matched to Subjects with Moderate Renal Impairment (absolute eGFR ≥90 and <130 mL/min) Receives: Drug: VCT220 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of VCT220
Measured: 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
Measured: 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)
Measured: From dosing through safety follow-up (Day 7 ± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start25 Dec 2025
- Primary completion18 Jan 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vincentage Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347808
- Sponsor's protocol ID
- VCT220-I-08
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07347808
- Acronym / sponsor ID
- VCT220-I-08
- Conditions
- Obesity & Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vincentage Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 18 Jan 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: VCT220Subjects with Moderate Renal Impairment (absolute eGFR ≥30 and <60 mL/min) |
| Group B | Experimental | Drug: VCT220Subjects with Normal Renal Function Matched to Subjects with Moderate Renal Impairment (absolute eGFR ≥90 and <130 mL/min) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VCT220Single oral dose of VCT220 40 mg administered after a standardized breakfast. | Drug | Group A, Group B |
Primary outcome
Maximum Plasma Concentration (Cmax) of VCT220
Time frame: 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
Time frame: 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
1 secondary outcome
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From dosing through safety follow-up (Day 7 ± 3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 9 inclusion and 8 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 27 Mar 2026. 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. 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?
Maximum Plasma Concentration (Cmax) of VCT220 (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.