ObesityPhase 2NCT06569355
A Study to Evaluate the Efficacy and Safety of VCT220 in Obesity Chinese Population
A Phase 2 study testing VCT220 in people with Obesity and Overweight, run by Vincentage Pharma Co., Ltd at 1 site in China.
Trial summary
The goal of the study is to assess how VCT220 tablets affect the bodyweight when used once daily in obese or overweight adult participants Qualified participants will be randomly assigned to one of four groups using a computerized system. 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
- 250 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2023to 1 Aug 2024
- Phase
- Phase 2
- 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
- Male or female subjects aged 18-75 years (inclusive) when signing the informed consent form;
- Body mass index (BMI) ≥ 28 kg/m2 with or without concomitant diseases; or BMI ≥ 24 kg/m2 and < 28 kg/m2 combined with at least one of the following concomitant diseases: pre-diabetes (impaired fasting glucose and/or reduced glucose tolerance), hypertension, dyslipidemia, fatty liver, and obstructive sleep apnea syndrome caused by overweight (see Appendix 1 for specific definitions);
- Subjects who have undergone diet control or exercise control alone for at least 12 weeks before screening, resulting in a stable weight within 12 weeks before screening (weight change < 5%, weight change = [maximum weight - minimum weight]/maximum weight; based on subjects' self-report);
- Subjects who have no fertility plan and voluntarily take effective contraceptive measures without any plans to donate sperm or eggs during the study and within 90 days after the end of study;
- Subjects who are willing and able to maintain a stable diet and exercise during the study and fill in diary cards on time; 6）Subjects who are able to understand the procedures and methods of this study, willing to complete this study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form.
Who cannot join
- Subjects with previously diagnosed obesity caused by endocrine diseases or single gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, islet cell tumor, acromegaly, and hypogonadism;
- Subjects who have received bariatric surgery or treatment (except for acupuncture for weight loss, liposuction, and abdominal fat removal more than 1 year from the screening period), or plan to receive bariatric surgery to treat obesity during the study, e.g., gastric bypass surgery and gastric banding;
- Subjects who are on a weight loss program at screening and are not in the maintenance period (based on subjects' self-report);
- Subjects who have previously been diagnosed with type 1 diabetes mellitus, type 2 diabetes mellitus, or other special types of diabetes;
- Subjects who have used any GLP-1 receptor agonist (GLP-1RA), GLP-1 related multi-target agonist (e.g., GLP 1/glucose-dependent insulinotropic polypeptide [GIP] dual agonist and GLP 1/glucagon receptor [GCGR] dual agonist), or compound preparations containing GLP 1 agonist;
- Subjects who have received any of the following medications or therapies within 12 weeks before screening:
Show all 44Show fewer
- Oral or injectable hypoglycemic medications such as dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium glucose cotransporter 2 (SGLT-2) inhibitors, metformin, insulin secretagogues, thiazolidinediones (TZDs), and insulin;
- Any approved or unapproved weight loss drugs (such as orlistat, lorcaserin, phentermine/topiramate, and naltrexone/bupropion) or Chinese herbal medicines, health care products, meal replacements, etc., affecting body weight;
- Use of any drugs that might significantly change body weights, including systemic (i.e., intravenous, oral, or intra-articular administration) glucocorticoids for more than 1 week; tricyclic antidepressants; antipsychotic or antiepileptic drugs (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valeric acid and its derivatives, lithium preparations, and thioridazine), etc.;
- Subjects who meet any of the following criteria related to cardiac function:
- History of myocardial infarction, coronary angioplasty or bypass graft, heart valve disorders or cardiac valve prostheses, clinically significant unstable arrhythmia, unstable angina, transient ischemic attack, cerebrovascular accident, etc., within 6 months before screening;
- Class III or IV congestive cardiac failure according to New York Heart Association (NYHA) classification;
- Subjects with serious arrhythmia requiring treatment (such as long QT syndrome) and not suitable for the clinical study as assessed by the investigator;
- Poorly controlled hypertension before screening (i.e., systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Presence of clinical abnormalities (e.g., QTcF > 450 msec, complete left bundle branch block, signs of acute or unexplained myocardial infarction, ST-segment changes suggestive of myocardial ischemia, second or third degree atrioventricular block, or serious bradyarrhythmia or tachyarrhythmia) by electrocardiography (ECG) at screening that might affect the safety of subjects or the interpretation of study results;
- Resting heart rate > 100 beats/min;
- Other cardiac function abnormalities with clinical significance judged by the investigator;
- Currently with thyroid dysfunction that is not well controlled with a stable dose of medications, or with clinically significant abnormalities noted in thyroid function test results at screening;
- History of medullary thyroid cancer, multiple endocrine neoplasia (MEN) syndrome type 2A or 2B or relevant family history (family history is defined as diseases in a first-degree relatives);
- Subjects diagnosed with malignancies within 5 years before screening (except for cured cutaneous basal cell carcinoma or cervical carcinoma in situ);
- History of acute or chronic pancreatitis, symptomatic gallbladder disease (such as multiple gallstones), pancreatic injury, and other high-risk factors that may lead to pancreatitis;
- Subjects with clinically significant abnormal gastric emptying (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (active ulcer within 6 months), long-term use of drugs with direct effects on gastrointestinal motility (including but not limited to mosapride, cisapride, etc.), or gastrointestinal surgery (except for polypectomy and appendectomy) within 6 months before screening, who are not suitable for the clinical study as assessed by the investigator;
- History of organ transplantation, or previous or current serious autoimmune diseases;
- Subjects who have a history of major surgery within 6 months before screening, or plan to undergo surgery that might affect study completion or compliance;
- Subjects with a history of moderate to severe depression and anxiety, or a history of serious mental illness, or a depression screening scale (PHQ-9) score ≥ 15 at screening;
- Subjects with previous suicidal tendency or suicidal behavior;
- Subjects with any laboratory test parameter meeting any of the following criteria at screening:
- Glycosylated hemoglobin (HbA1c) ≥ 6.5%;
- Fasting plasma glucose (FPG) ≥ 7.0 mmol/L;
- Glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 as calculated using the CKD-EPI formula;
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 3.0 × upper limit of normal (ULN);
- Total bilirubin (TBIL) > 1.5 × ULN;
- Blood amylase or blood lipase > 1.5 × ULN;
- Fasting triglycerides (TG) > 5.7 mmol/L;
- Fasting C-peptide < 0.8 ng/mL (or < 0.26 nmol/L);
- Calcitonin ≥ 1.0 × ULN;
- Hemoglobin (Hb) < 110 g/L (males) or < 100 g/L (females);
- Subjects who are positive for hepatitis B virus surface antigen (HBsAg) (except for those with hepatitis B virus deoxyribonucleic acid [HBV-DNA] quantitative results lower than the lower limit of reference range and not using anti-hepatitis B virus drugs at screening), receiving anti-hepatitis B virus drugs, positive for hepatitis C virus (HCV) antibody, positive for human immunodeficiency virus (HIV) antibody, or positive for treponema pallidum antibody (Tp-Ab) at screening;
- Subjects with known allergies to GLP-1 receptor agonists or relevant excipients;
- Subjects who have previously participated in weight loss clinical trials; those who have participated in any clinical trial for drug or medical device (except for weight loss clinical trials) as subjects within 12 weeks before screening, or subjects who have participated in any clinical trials in which the last dose is within 5 half-lives of the investigational product before screening (whichever is longer) (such restrictions are not applicable to the subjects who fail the screening);
- Subjects who have donated or lost ≥ 400 mL of blood or have received blood transfusion within 12 weeks before screening;
- Subjects with a known or suspected history of alcohol or tobacco addiction, or drug abuse at screening;
- Pregnant or lactating women;
- Subjects with positive blood pregnancy test results at screening or before randomization (for female subjects of childbearing potential only); 25）Other conditions that make the subject unsuitable for the study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VCT220 Tablets in Overweight/Obese Subjects
The goal of the study is to assess how VCT220 tablets affect the bodyweight when used once daily in obese or overweight adult participants
Qualified participants will be randomly assigned to one of four groups using a computerized system. Participants will get VCT220 or placebo tablets for 16 weeks and will need to take tablets each morning.
Participants will have 7 clinic visits and a final follow-up visit approximately 14 days after the last study intervention administration.
Read the detailed description
Not provided
- 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
A small molecule GLP-1R agonist tablet, orally administration, once daily
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 80mg dose group | Experimental | Participants will receive VCT220 or placebo tables in 2 weeks dose titration period and take the maintanance dose 80 mg from week 3 to week 16. Receives: Drug: VCT220; Drug: Placebo |
| 120mg dose group | Experimental | Participants will receive VCT220 or placebo tables in 4 weeks dose titration period and take the maintanance dose 120 mg from week 5 to week 16. Receives: Drug: VCT220; Drug: Placebo |
| 160mg dose group fast titration | Experimental | Participants will receive VCT220 or placebo tables in 4 weeks dose titration period and take the maintanance dose 160 mg from week 5 to week 16. Receives: Drug: VCT220; Drug: Placebo |
| 160mg dose group slow titration | Experimental | Participants will receive VCT220 or placebo tables in 6 weeks dose titration period and take the maintanance dose 160 mg from week 7 to week 16. Receives: Drug: VCT220; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight
percentage-point
Measured: From baseline (week 1) to week 16
Secondary outcomes (9)
Proportion of subjects with weight decrease ≥ 5%
percentage-point
Measured: From baseline (week 1) to week 16
Absolute change in body weight
measured in kg
Measured: From baseline (week 1) to week 16
Absolute change in body mass index (BMI)
measured in kg/m^2
Measured: From baseline (week 1) to week 16
Absolute change in waist circumference
measured in cm
Measured: From baseline (week 1) to week 16
Change in blood lipid profiles (TC, TG, LDL-C, and HDL-C)
measured in mmol/L
Measured: From baseline (week 1) to week 16
Change in fasting plasma glucose (FPG)
measured in mmol/L
Measured: From baseline (week 1) to week 16
Change in HbA1c (glycated haemoglobin)
percentage-point
Measured: From baseline (week 1) to week 16
Change in fasting insulin
measured in μIU/mL
Measured: From baseline (week 1) to week 16
Change in fasting C-peptide
measured in ng/ml
Measured: From baseline (week 1) to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start27 Dec 2023
- Primary completion13 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 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
- NCT06569355
- Sponsor's protocol ID
- VCT220-II-02
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ji L, Gao L, Li B, Liu M, Zhang X, Meng C. Oral nonpeptide GLP-1 receptor agonist VCT220 for obesity treatment: a randomized, double-blind, phase II trial. Signal Transduct Target Ther. 2026 Aug 14;11(1):325. doi: 10.1038/s41392-026-02859-2.
PubMed 42595749
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VCT220 Tablets in Overweight/Obese Subjects
- ClinicalTrials.gov ID
- NCT06569355
- Acronym / sponsor ID
- VCT220-II-02
- Conditions
- Obesity, Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Vincentage Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 13 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 26 Aug 2024 (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 goal of the study is to assess how VCT220 tablets affect the bodyweight when used once daily in obese or overweight adult participants
Qualified participants will be randomly assigned to one of four groups using a computerized system. Participants will get VCT220 or placebo tablets for 16 weeks and will need to take tablets each morning.
Participants will have 7 clinic visits and a final follow-up visit approximately 14 days after the last study intervention administration.
Detailed description
Not provided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 80mg dose group | Experimental | Drug: VCT220, Drug: PlaceboParticipants will receive VCT220 or placebo tables in 2 weeks dose titration period and take the maintanance dose 80 mg from week 3 to week 16. |
| 120mg dose group | Experimental | Drug: VCT220, Drug: PlaceboParticipants will receive VCT220 or placebo tables in 4 weeks dose titration period and take the maintanance dose 120 mg from week 5 to week 16. |
| 160mg dose group fast titration | Experimental | Drug: VCT220, Drug: PlaceboParticipants will receive VCT220 or placebo tables in 4 weeks dose titration period and take the maintanance dose 160 mg from week 5 to week 16. |
| 160mg dose group slow titration | Experimental | Drug: VCT220, Drug: PlaceboParticipants will receive VCT220 or placebo tables in 6 weeks dose titration period and take the maintanance dose 160 mg from week 7 to week 16. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged 18-75 years (inclusive) when signing the informed consent form;
- Body mass index (BMI) ≥ 28 kg/m2 with or without concomitant diseases; or BMI ≥ 24 kg/m2 and < 28 kg/m2 combined with at least one of the following concomitant diseases: pre-diabetes (impaired fasting glucose and/or reduced glucose tolerance), hypertension, dyslipidemia, fatty liver, and obstructive sleep apnea syndrome caused by overweight (see Appendix 1 for specific definitions);
- Subjects who have undergone diet control or exercise control alone for at least 12 weeks before screening, resulting in a stable weight within 12 weeks before screening (weight change < 5%, weight change = [maximum weight - minimum weight]/maximum weight; based on subjects' self-report);
- Subjects who have no fertility plan and voluntarily take effective contraceptive measures without any plans to donate sperm or eggs during the study and within 90 days after the end of study;
- Subjects who are willing and able to maintain a stable diet and exercise during the study and fill in diary cards on time; 6）Subjects who are able to understand the procedures and methods of this study, willing to complete this study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form.
Key exclusion criteria (44 listed)
- Subjects with previously diagnosed obesity caused by endocrine diseases or single gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, islet cell tumor, acromegaly, and hypogonadism;
- Subjects who have received bariatric surgery or treatment (except for acupuncture for weight loss, liposuction, and abdominal fat removal more than 1 year from the screening period), or plan to receive bariatric surgery to treat obesity during the study, e.g., gastric bypass surgery and gastric banding;
- Subjects who are on a weight loss program at screening and are not in the maintenance period (based on subjects' self-report);
- Subjects who have previously been diagnosed with type 1 diabetes mellitus, type 2 diabetes mellitus, or other special types of diabetes;
- Subjects who have used any GLP-1 receptor agonist (GLP-1RA), GLP-1 related multi-target agonist (e.g., GLP 1/glucose-dependent insulinotropic polypeptide [GIP] dual agonist and GLP 1/glucagon receptor [GCGR] dual agonist), or compound preparations containing GLP 1 agonist;
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 |
|---|---|---|
| VCT220A small molecule GLP-1R agonist tablet, orally administration, once daily | Drug | 120mg dose group, 160mg dose group fast titration, 160mg dose group slow titration, 80mg dose group |
| PlaceboPlacebo tablet | Drug | 120mg dose group, 160mg dose group fast titration, 160mg dose group slow titration, 80mg dose group |
Primary outcome
Percentage change in body weight
Time frame: From baseline (week 1) to week 16
percentage-point
9 secondary outcomes
Proportion of subjects with weight decrease ≥ 5%
Time frame: From baseline (week 1) to week 16
Absolute change in body weight
Time frame: From baseline (week 1) to week 16
Absolute change in body mass index (BMI)
Time frame: From baseline (week 1) to week 16
Absolute change in waist circumference
Time frame: From baseline (week 1) to week 16
Change in blood lipid profiles (TC, TG, LDL-C, and HDL-C)
Time frame: From baseline (week 1) to week 16
Change in fasting plasma glucose (FPG)
Time frame: From baseline (week 1) to week 16
Change in HbA1c (glycated haemoglobin)
Time frame: From baseline (week 1) to week 16
Change in fasting insulin
Time frame: From baseline (week 1) to week 16
Change in fasting C-peptide
Time frame: From baseline (week 1) to week 16
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 1 Jul 2025.
- Derived from this study: PubMed 42595749Ji L, Gao L, Li B, Liu M, Zhang X, Meng C. Oral nonpeptide GLP-1 receptor agonist VCT220 for obesity treatment: a randomized, double-blind, phase II trial. Signal Transduct Target Ther. 2026 Aug 14;11(1):325. doi: 10.1038/s41392-026-02859-2.
- 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 2 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 5 inclusion and 44 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 1 Jul 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in body weight (time frame: From baseline (week 1) to week 16). 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 NCT06569355, which also lists 1 linked publication.
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 1 Jul 2025.