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NCT Number: NCT06939296

A Research Study of VCT220 in Adult Chinese Participants With Obesity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital ( There are multiple sites in this clinical trial)

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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:
  • 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.).

Treatment and study plan

VCT220

Drug

A small molecule GLP-1R drug, film coated tablet

Other names: CX11

Placebo

Drug

Placebo tablets

Primary outcomes

  1. Percentage change from baseline in body weight

    Time frame: From baseline to week 34

  2. The proportion of subjects with a body weight reduction ≥5% from baseline

    Time frame: From baseline to week 34

Secondary outcomes

  1. Percentage change from baseline in waist circumference

    Time frame: From baseline to week 34

  2. Percentage change from baseline in body weight

    Time frame: From baseline to week 52

  3. The proportion of subjects with a body weight reduction of ≥10%, ≥15%, and ≥20%

    Time frame: From baseline to week 34 and week 52

  4. The proportion of subjects with a body weight reduction of ≥5% from baseline

    Time frame: From baseline to week 52

  5. Percentage change from baseline in body mass index (BMI)

    Time frame: From baseline to week 52

  6. Percentage change from baseline in waist circumference

    Time frame: From baseline to week 52

  7. Percentage change from baseline in blood pressure

    Time frame: From baseline to week 52

    DBP and SBP

  8. Percentage change from baseline in blood lipid profiles

    Time frame: From baseline to week 52

    TC, TG, LDL-C, and HDL-C

  9. Percentage change from baseline in fasting plasma glucose

    Time frame: From baseline to week 52

  10. Percentage change from baseline in fasting insulin

    Time frame: From baseline to week 52

  11. Percentage change from baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: From baseline to week 52

  12. 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.

  13. 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.

Other outcomes

  1. Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)

    Time frame: From week 0 to week 56

  2. 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

Sponsors and collaborators

Lead sponsor

Vincentage Pharma Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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