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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose group | Experimental | Participants will receive VCT220 orally, once daily, titrate during 8 weeks and maintain at a high dose. |
|
| Moderate dose group | Experimental | Participants will receive VCT220 orally, once daily, titrate during 6 weeks and maintain at a moderate dose. |
|
| Placebo group | Placebo Comparator | Participants will receive placebo tablets orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCT220 | Drug | A small molecule GLP-1R drug, film coated tablet |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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% |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) | From week 0 to week 56 | |
| Change from baseline in liver fat content measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) | From baseline to week 52 |
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital ( There are multiple sites in this clinical trial) | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Drug | Placebo tablets |
|
| 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 waist circumference | From baseline to week 52 |
| Percentage change from baseline in blood pressure | DBP and SBP | From baseline to week 52 |
| Percentage change from baseline in blood lipid profiles | TC, TG, LDL-C, and HDL-C | From baseline to week 52 |
| 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 | 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. | From baseline to week 52 |
| Improvement in quality of life | 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. | From baseline to week 52 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |