A Research Study of VCT220 in Adult Chinese Participants With Obesity

Phase 3

Active, not recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: VCT220; Drug: Placebo

• Registration Number: NCT06939296
• Lead Sponsor: Vincentage Pharma Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-24
• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-21
• Last Update Submitted: 2025-04-21
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-10-25
• Study Completion: 2026-03-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 840

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose group	VCT220	Participants will receive VCT220 orally, once daily, titrate during 8 weeks and maintain at a high dose.
Moderate dose group	VCT220	Participants will receive VCT220 orally, once daily, titrate during 6 weeks and maintain at a moderate dose.
Placebo group	Placebo	Participants will receive placebo tablets orally, once daily

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline in body weight	From baseline to week 34
The proportion of subjects with a body weight reduction ≥5% from baseline	From baseline to week 34

Secondary Outcome Measures

Name	Time	Method
Percentage change from baseline in body mass index (BMI)	From baseline to week 52
Percentage change from baseline in blood lipid profiles	From baseline to week 52	TC, TG, LDL-C, and HDL-C
Percentage change from baseline in waist circumference	From baseline to week 52
Percentage change from baseline in body weight	From baseline to week 52
The proportion of subjects with a body weight reduction of ≥10%, ≥15%, and ≥20%	From baseline to week 34 and week 52
The proportion of subjects with a body weight reduction of ≥5% from baseline	From baseline to week 52
Percentage change from baseline in blood pressure	From baseline to week 52	DBP and SBP
Percentage change from baseline in fasting plasma glucose	From baseline to week 52
Percentage change from baseline in fasting insulin	From baseline to week 52
Percentage change from baseline in Glycosylated Hemoglobin (HbA1c)	From baseline to week 52
Improvement in quality of life	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.

Trial Locations

Locations (1)

Peking University People's Hospital （ There are multiple sites in this clinical trial）; 🇨🇳 Beijing, Beijing, China