ObesityPhase 3NCT06939296
A Research Study of VCT220 in Adult Chinese Participants With Obesity
A Phase 3 study testing VCT220 in people with Obesity and Overweight, run by Vincentage Pharma Co., Ltd at 1 site in China.
Trial summary
The main purpose of this study is to assess how VCT220 tablets affect the bodyweight in obese or overweight adult participants. Participant will be randomly assigned to the high-dose group, low-dose group, or placebo group. Each participant will take the study drug orally once daily for 12 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 840 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2024to 31 Mar 2026
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, both male and female;
- At screening, BMI ≥ 28 kg/m² or 24 kg/m² ≤ BMI < 28 kg/m² with at least one of the following conditions:
- Comorbid prediabetes (impaired fasting glucose and/or abnormal glucose tolerance), hypertension, dyslipidemia, or fatty liver (within the past 6 months prior to screening);
- Comorbid weight-bearing joint pain (as determined by the investigator, excluding joint pain caused by other diseases);
- Obesity-related shortness of breath or obstructive sleep apnea syndrome;
- Weight change during the past 3 months due to diet and exercise control should not exceed 5% (self-reported); weight change calculation formula: (highest weight - lowest weight in the past 3 months) / highest weight * 100%;
- Willing and able to maintain a stable diet and exercise regimen throughout the study;
- Fully understands the purpose of the study, able to communicate well with the investigator, can comprehend and comply with the requirements of this study, and is willing to sign the informed consent form
Who cannot join
- Patients with type 1, type 2, or other types of diabetes.
- A history of endocrine diseases or obesity caused by single gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, and hypogonadism.
- A history of weight-loss surgery (except for liposuction performed more than 1 year ago) or plans to undergo weight-loss surgery, use weight-loss devices, or medical equipment during the study.
- Has used any of the following medications or treatments:
- Has previously used any GLP-1 receptor agonists (GLP-1RAs), GLP-1-related multi-target agonists (such as GLP-1/glucose-dependent insulinotropic peptide [GIP] dual receptor agonists, GLP-1 receptor/glucagon receptor [GCGR] dual agonists, GLP-1/GIP/glucagon [GCG] triple receptor agonists, etc.), or combination formulations containing GLP-1RAs (such as exenatide, liraglutide, semaglutide, benaglutide, etc.);
- Within the past 6 months prior to screening, has used any approved or unapproved weight-loss medications other than GLP-1 receptor agonists (GLP-1RAs) and GLP-1-related multi-target agonists (such as orlistat, phentermine/topiramate, naltrexone/bupropion, etc.), or weight-affecting herbal medicines, supplements, meal replacements, etc.;
- Within the past 3 months prior to screening, has used any antidiabetic medications, such as metformin, α-glucosidase inhibitors, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, thiazolidinediones (TZDs), etc.;
- Within the past 3 months prior to screening, has used any medications that may cause significant weight gain, including systemic corticosteroid treatment for more than 1 week, tricyclic antidepressants, antipsychotic or anticonvulsant medications (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, clozapine, olanzapine, valproic acid and its derivatives, lithium salts, methyldopa, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital （ There are multiple sites in this clinical trial）
Beijing, Beijing Municipality
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VCT220 Tablets in Overweight or Obese Participants
The main purpose of this study is to assess how VCT220 tablets affect the bodyweight in obese or overweight adult participants. Participant will be randomly assigned to the high-dose group, low-dose group, or placebo group. Each participant will take the study drug orally once daily for 12 months.
- Conditions
- Obesity, Overweight
- 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
Also called CX11
A small molecule GLP-1R drug, film coated tablet
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Experimental | Participants will receive VCT220 orally, once daily, titrate during 8 weeks and maintain at a high dose. Receives: Drug: VCT220 |
| Moderate dose group | Experimental | Participants will receive VCT220 orally, once daily, titrate during 6 weeks and maintain at a moderate dose. Receives: Drug: VCT220 |
| Placebo group | Placebo comparator | Participants will receive placebo tablets orally, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in body weight
Measured: From baseline to week 34
The proportion of subjects with a body weight reduction ≥5% from baseline
Measured: From baseline to week 34
Secondary outcomes (13)
Percentage change from baseline in waist circumference
Measured: From baseline to week 34
Percentage change from baseline in body weight
Measured: From baseline to week 52
The proportion of subjects with a body weight reduction of ≥10%, ≥15%, and ≥20%
Measured: From baseline to week 34 and week 52
The proportion of subjects with a body weight reduction of ≥5% from baseline
Measured: From baseline to week 52
Percentage change from baseline in body mass index (BMI)
Measured: From baseline to week 52
Percentage change from baseline in waist circumference
Measured: From baseline to week 52
Percentage change from baseline in blood pressure
DBP and SBP
Measured: From baseline to week 52
Percentage change from baseline in blood lipid profiles
TC, TG, LDL-C, and HDL-C
Measured: From baseline to week 52
Percentage change from baseline in fasting plasma glucose
Measured: From baseline to week 52
Percentage change from baseline in fasting insulin
Measured: From baseline to week 52
Percentage change from baseline in Glycosylated Hemoglobin (HbA1c)
Measured: From baseline to week 52
Improvement in quality of life
Measured by Impact of Weight on Quality of Life-Lite Clinical Trials questionnaire（IWQoL-Lite-CT ). The IWQoL-Lite-CT has 20 items, each scored on a 5-point Likert scale, with a total score of 100. Higher scores indicate less negative impact of weight on quality of life.
Measured: From baseline to week 52
Improvement in quality of life
Measured by Medical Outcomes Study 36-Item Short-Form Health Survey questionnaire version 2 (SF-36 v2) . It contains 36 items grouped into 8 domains, Each item is scored based on a predefined scale. Higher scores indicate better health-related quality of life.
Measured: From baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start24 Dec 2024
- Primary completion25 Nov 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 840 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
- NCT06939296
- Sponsor's protocol ID
- VCT220-III-01
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VCT220 Tablets in Overweight or Obese Participants
- ClinicalTrials.gov ID
- NCT06939296
- Acronym / sponsor ID
- VCT220-III-01
- Conditions
- Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Vincentage Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 22 Apr 2025 (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.
The main purpose of this study is to assess how VCT220 tablets affect the bodyweight in obese or overweight adult participants. Participant will be randomly assigned to the high-dose group, low-dose group, or placebo group. Each participant will take the study drug orally once daily for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose group | Experimental | Drug: VCT220Participants will receive VCT220 orally, once daily, titrate during 8 weeks and maintain at a high dose. |
| Moderate dose group | Experimental | Drug: VCT220Participants will receive VCT220 orally, once daily, titrate during 6 weeks and maintain at a moderate dose. |
| Placebo group | Placebo comparator | Drug: PlaceboParticipants will receive placebo tablets orally, once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years, both male and female;
- At screening, BMI ≥ 28 kg/m² or 24 kg/m² ≤ BMI < 28 kg/m² with at least one of the following conditions:
- Weight change during the past 3 months due to diet and exercise control should not exceed 5% (self-reported); weight change calculation formula: (highest weight - lowest weight in the past 3 months) / highest weight * 100%;
- Willing and able to maintain a stable diet and exercise regimen throughout the study;
- Fully understands the purpose of the study, able to communicate well with the investigator, can comprehend and comply with the requirements of this study, and is willing to sign the informed consent form
Key exclusion criteria (8 listed)
- Patients with type 1, type 2, or other types of diabetes.
- A history of endocrine diseases or obesity caused by single gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, and hypogonadism.
- A history of weight-loss surgery (except for liposuction performed more than 1 year ago) or plans to undergo weight-loss surgery, use weight-loss devices, or medical equipment during the study.
- Has used any of the following medications or treatments:
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 |
|---|---|---|
| VCT220Also: CX11A small molecule GLP-1R drug, film coated tablet | Drug | High dose group, Moderate dose group |
| PlaceboPlacebo tablets | Drug | Placebo group |
Primary outcome
Percentage change from baseline in body weight
Time frame: From baseline to week 34
The proportion of subjects with a body weight reduction ≥5% from baseline
Time frame: From baseline to week 34
13 secondary outcomes
Percentage change from baseline in waist circumference
Time frame: From baseline to week 34
Percentage change from baseline in body weight
Time frame: From baseline to week 52
The proportion of subjects with a body weight reduction of ≥10%, ≥15%, and ≥20%
Time frame: From baseline to week 34 and week 52
The proportion of subjects with a body weight reduction of ≥5% from baseline
Time frame: From baseline to week 52
Percentage change from baseline in body mass index (BMI)
Time frame: From baseline to week 52
Percentage change from baseline in waist circumference
Time frame: From baseline to week 52
Percentage change from baseline in blood pressure
Time frame: From baseline to week 52
Percentage change from baseline in blood lipid profiles
Time frame: From baseline to week 52
Percentage change from baseline in fasting plasma glucose
Time frame: From baseline to week 52
Percentage change from baseline in fasting insulin
Time frame: From baseline to week 52
Percentage change from baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: From baseline to week 52
Improvement in quality of life
Time frame: From baseline to week 52
Improvement in quality of life
Time frame: From baseline to week 52
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 16 Sep 2026.
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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 3 study testing VCT220 in people with Obesity and 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 8 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 16 Sep 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage change from baseline in body weight (time frame: From baseline to week 34). 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 16 Sep 2026.