A Research Study of VCT220 in Adult Chinese Participants With Obesity

Vincentage Pharma Co., Ltd

Status and phase: Active, not recruiting; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: VCT220

Study type: Interventional

Funder types: Industry

Identifiers

NCT06939296

VCT220-III-01

Details and patient eligibility

About

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.

Enrollment: 840 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

840 participants in 3 patient groups, including a placebo group

High dose group

Experimental group

Description:

Participants will receive VCT220 orally, once daily, titrate during 8 weeks and maintain at a high dose.

Treatment:

Drug: VCT220

Moderate dose group

Experimental group

Description:

Participants will receive VCT220 orally, once daily, titrate during 6 weeks and maintain at a moderate dose.

Treatment:

Drug: VCT220

Placebo group

Placebo Comparator group

Description:

Participants will receive placebo tablets orally, once daily

Treatment:

Drug: Placebo