Obesity, Overweight
Conditions
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.
Interventions
DRUGVCT220
A small molecule GLP-1R drug, film coated tablet
DRUGPlacebo
Placebo tablets
Sponsors
Vincentage Pharma Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in waist circumference | From baseline to week 34 | — |
| 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 body mass index (BMI) | 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 blood lipid profiles | From baseline to week 52 | TC, TG, LDL-C, and HDL-C |
| 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 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. |
Countries
China
Outcome results
None listed