A Research Study of VCT220 in Adult Chinese Participants With Obesity

March 25, 2026 updated by: Vincentage Pharma Co., Ltd

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking University People's Hospital （ There are multiple sites in this clinical trial）

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. Comorbid prediabetes (impaired fasting glucose and/or abnormal glucose tolerance), hypertension, dyslipidemia, or fatty liver (within the past 6 months prior to screening);
    2. Comorbid weight-bearing joint pain (as determined by the investigator, excluding joint pain caused by other diseases);
    3. 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

Exclusion Criteria:

  • 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:

    1. 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.);
    2. 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.;
    3. 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.;
    4. 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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose group
Participants will receive VCT220 orally, once daily, titrate during 8 weeks and maintain at a high dose.
Drug: VCT220
A small molecule GLP-1R drug, film coated tablet
Other Names:
  • CX11
Experimental: Moderate dose group
Participants will receive VCT220 orally, once daily, titrate during 6 weeks and maintain at a moderate dose.
Drug: VCT220
A small molecule GLP-1R drug, film coated tablet
Other Names:
  • CX11
Placebo Comparator: Placebo group
Participants will receive placebo tablets orally, once daily
Drug: Placebo
Placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change from baseline in body weight
Time Frame: From baseline to week 34
From baseline to week 34
The proportion of subjects with a body weight reduction ≥5% from baseline
Time Frame: From baseline to week 34
From baseline to week 34

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change from baseline in waist circumference
Time Frame: From baseline to week 34
From baseline to week 34
Percentage change from baseline in body weight
Time Frame: From baseline to week 52
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
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
From baseline to week 52
Percentage change from baseline in body mass index (BMI)
Time Frame: From baseline to week 52
From baseline to week 52
Percentage change from baseline in waist circumference
Time Frame: From baseline to week 52
From baseline to week 52
Percentage change from baseline in blood pressure
Time Frame: From baseline to week 52
DBP and SBP
From baseline to week 52
Percentage change from baseline in blood lipid profiles
Time Frame: From baseline to week 52
TC, TG, LDL-C, and HDL-C
From baseline to week 52
Percentage change from baseline in fasting plasma glucose
Time Frame: From baseline to week 52
From baseline to week 52
Percentage change from baseline in fasting insulin
Time Frame: From baseline to week 52
From baseline to week 52
Percentage change from baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame: From baseline to week 52
From baseline to week 52
Improvement in quality of life
Time Frame: From baseline to week 52
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.
From baseline to week 52
Improvement in quality of life
Time Frame: From baseline to week 52
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.
From baseline to week 52

Other Outcome Measures

Outcome Measure
Time Frame
Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)
Time Frame: From week 0 to week 56
From week 0 to week 56
Change from baseline in liver fat content measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
Time Frame: From baseline to week 52
From baseline to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vincentage Pharma Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2024

Primary Completion (Actual)

November 25, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCT220-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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