Obesity & OverweightPhase 1NCT07349381
A Food-Effect Study of CX11 in Healthy Participants
A Phase 1 study testing CX11 (VCT220) in people with Obesity & Overweight and Type 2 Diabetes, run by Vincentage Pharma Co., Ltd at 1 site in China.
Trial summary
This study is to evaluate the food effect (FE) on the PK of 200 mg CX11 in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Type 2 Diabetes
- What is being tested?
- CX11 (VCT220)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2026to 30 Aug 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fully understand the objective, nature, methods, and possible adverse reactions of the study; be able to communicate well with the investigator; voluntarily take part in the study and be willing to comply with the requirements of this study; and sign the informed consent form before all study procedures are started
- Weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) is ≥ 20.0 kg/m2 and < 28 kg/m2 at the screening visit and on Day 21.
Who cannot join
- Participants with allergic constitution or known previous history of allergy to CX11 or similar compounds and related excipients, or history of atopic allergic diseases
- Participants who have experienced clinically significant acute diseases during the pre-study screening period or within 2 weeks prior to the first dose of the investigational product
- Participants who have pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could affect drug absorption, distribution, metabolism, and/or excretion as judged by the investigator, or plan to receive any surgery during the study
- Participants suffering from any clinically significant chronic diseases, including but not limited to disorders of the respiratory system, cardiovascular system, urinary system, blood system, endocrine system, and immune system, as well as the digestive system (e.g., history of or current fatty liver disease, including metabolic dysfunction-associated steatohepatitis
- History of thyroid dysfunction requiring medication or with a thyroid stimulating hormone (TSH) level exceeding the normal reference range at screening or on Day 21
- Participants who have been vaccinated within 30 days before the screening or plan to be vaccinated during the study
- Participated in any other clinical study and received an investigational intervention within 90 days or 5 elimination half-lives (whichever is longer) of the investigational intervention, prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Multiple-dose, Two-cycle, Two-way Crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of CX11 Tablets in Healthy Participants
This study is to evaluate the food effect (FE) on the PK of 200 mg CX11 in healthy participants
- Conditions
- Obesity & Overweight, Type 2 Diabetes
- Being tested
- CX11 (VCT220)
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX11 (VCT220)Drug
CX11 (VCT220) administered orally to participants who are in fasted/fed state in the first 6 consecutive days, and in fed/fasted state on the 7th day
| Study group | Role | What they receive |
|---|---|---|
| Fasted-Fed Arm | Experimental | Fasted-Fed Group Receives: Drug: CX11 (VCT220) |
| Fed-Fasted Arm | Experimental | Fed-Fasted Group Receives: Drug: CX11 (VCT220) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of CX11 (VCT220)
AUC0-24 of of CX11 (VCT220)
Measured: Predose at Day1 up to 35 days postdose
Maximum Observed Concentration (Cmax) of CX11 (VCT220)
Cmax of CX11 (VCT220)
Measured: Predose at Day1 up to 35 days postdose
Time to Maximum Observed Concentration (Tmax) of CX11 (VCT220)
Tmax of CX11 (VCT220)
Measured: Predose at Day 1 up to 35 days postdose
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 start4 Mar 2026
- Primary completion30 Jun 2026
- Study completion30 Aug 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vincentage Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Corxel Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349381
- Sponsor's protocol ID
- CX11101
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multiple-dose, Two-cycle, Two-way Crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of CX11 Tablets in Healthy Participants
- ClinicalTrials.gov ID
- NCT07349381
- Acronym / sponsor ID
- CX11101
- Conditions
- Obesity & Overweight, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vincentage Pharma Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Corxel Pharmaceuticals
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Aug 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 study is to evaluate the food effect (FE) on the PK of 200 mg CX11 in healthy participants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasted-Fed Arm | Experimental | Drug: CX11 (VCT220)Fasted-Fed Group |
| Fed-Fasted Arm | Experimental | Drug: CX11 (VCT220)Fed-Fasted Group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fully understand the objective, nature, methods, and possible adverse reactions of the study; be able to communicate well with the investigator; voluntarily take part in the study and be willing to comply with the requirements of this study; and sign the informed consent form before all study procedures are started
- Weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) is ≥ 20.0 kg/m2 and < 28 kg/m2 at the screening visit and on Day 21.
Key exclusion criteria (7 listed)
- Participants with allergic constitution or known previous history of allergy to CX11 or similar compounds and related excipients, or history of atopic allergic diseases
- Participants who have experienced clinically significant acute diseases during the pre-study screening period or within 2 weeks prior to the first dose of the investigational product
- Participants who have pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could affect drug absorption, distribution, metabolism, and/or excretion as judged by the investigator, or plan to receive any surgery during the study
- Participants suffering from any clinically significant chronic diseases, including but not limited to disorders of the respiratory system, cardiovascular system, urinary system, blood system, endocrine system, and immune system, as well as the digestive system (e.g., history of or current fatty liver disease, including metabolic dysfunction-associated steatohepatitis
- History of thyroid dysfunction requiring medication or with a thyroid stimulating hormone (TSH) level exceeding the normal reference range at screening or on Day 21
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 |
|---|---|---|
| CX11 (VCT220)CX11 (VCT220) administered orally to participants who are in fasted/fed state in the first 6 consecutive days, and in fed/fasted state on the 7th day | Drug | Fasted-Fed Arm, Fed-Fasted Arm |
Primary outcome
Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of CX11 (VCT220)
Time frame: Predose at Day1 up to 35 days postdose
AUC0-24 of of CX11 (VCT220)
Maximum Observed Concentration (Cmax) of CX11 (VCT220)
Time frame: Predose at Day1 up to 35 days postdose
Cmax of CX11 (VCT220)
Time to Maximum Observed Concentration (Tmax) of CX11 (VCT220)
Time frame: Predose at Day 1 up to 35 days postdose
Tmax of CX11 (VCT220)
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 13 Oct 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 CX11 (VCT220) in people with Obesity & Overweight and Type 2 Diabetes, 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 2 inclusion and 7 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 13 Oct 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?
Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of CX11 (VCT220) (time frame: Predose at Day1 up to 35 days postdose). 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?
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 13 Oct 2026.