Clinical trial NCT06939296: A Research Study of VCT220 in Adult Chinese Participants With Obesity
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Lead sponsor: Vincentage Pharma Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-22
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Percentage change from baseline in body weight
timeFrame: From baseline to week 34
measure: The proportion of subjects with a body weight reduction ≥5% from baseline
timeFrame: From baseline to week 34
Secondary outcomes:
measure: Percentage change from baseline in waist circumference
timeFrame: From baseline to week 34
measure: Percentage change from baseline in body weight
timeFrame: From baseline to week 52
measure: The proportion of subjects with a body weight reduction of ≥10%, ≥15%, and ≥20%
timeFrame: From baseline to week 34 and week 52
measure: The proportion of subjects with a body weight reduction of ≥5% from baseline
timeFrame: From baseline to week 52
measure: Percentage change from baseline in body mass index (BMI)
timeFrame: From baseline to week 52
measure: Percentage change from baseline in waist circumference
timeFrame: From baseline to week 52
measure: Percentage change from baseline in blood pressure
timeFrame: From baseline to week 52
measure: Percentage change from baseline in blood lipid profiles
timeFrame: From baseline to week 52
measure: Percentage change from baseline in fasting plasma glucose
timeFrame: From baseline to week 52
measure: Percentage change from baseline in fasting insulin
timeFrame: From baseline to week 52
measure: Percentage change from baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: From baseline to week 52
measure: Improvement in quality of life
timeFrame: From baseline to week 52
measure: Improvement in quality of life
timeFrame: From baseline to week 52
Other outcomes:
measure: Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)
timeFrame: From week 0 to week 56
measure: Change from baseline in liver fat content measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
timeFrame: From baseline to week 52
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital （ There are multiple sites in this clinical trial）
state: Beijing
Study officials:
References: