A Study to Evaluate the Efficacy and Safety of VCT220 in Obesity Chinese Population

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 250

Inclusion Criteria

Inclusion Criteria: 1. Male or female subjects aged 18-75 years (inclusive) when signing the informed consent form; 2. Body mass index (BMI) = 28 kg/m2 with or without concomitant diseases; or BMI = 24 kg/m2 and < 28 kg/m2 combined with at least one of the following concomitant diseases: pre-diabetes (impaired fasting glucose and/or reduced glucose tolerance), hypertension, dyslipidemia, fatty liver, and obstructive sleep apnea syndrome caused by overweight (see Appendix 1 for specific definitions); 3. Subjects who have undergone diet control or exercise control alone for at least 12 weeks before screening, resulting in a stable weight within 12 weeks before screening (weight change < 5%, weight change = [maximum weight - minimum weight]/maximum weight; based on subjects' self-report); 4. Subjects who have no fertility plan and voluntarily take effective contraceptive measures without any plans to donate sperm or eggs during the study and within 90 days after the end of study; 5. Subjects who are willing and able to maintain a stable diet and exercise during the study and fill in diary cards on time; 6)Subjects who are able to understand the procedures and methods of this study, willing to complete this study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form. Exclusion Criteria: 1. Subjects with previously diagnosed obesity caused by endocrine diseases or single gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, islet cell tumor, acromegaly, and hypogonadism; 2. Subjects who have received bariatric surgery or treatment (except for acupuncture for weight loss, liposuction, and abdominal fat removal more than 1 year from the screening period), or plan to receive bariatric surgery to treat obesity during the study, e.g., gastric bypass surgery and gastric banding; 3. Subjects who are on a weight loss program at screening and are not in the maintenance period (based on subjects' self-report); 4. Subjects who have previously been diagnosed with type 1 diabetes mellitus, type 2 diabetes mellitus, or other special types of diabetes; 5. Subjects who have used any GLP-1 receptor agonist (GLP-1RA), GLP-1 related multi-target agonist (e.g., GLP 1/glucose-dependent insulinotropic polypeptide [GIP] dual agonist and GLP 1/glucagon receptor [GCGR] dual agonist), or compound preparations containing GLP 1 agonist; 6. Subjects who have received any of the following medications or therapies within 12 weeks before screening: - Oral or injectable hypoglycemic medications such as dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium glucose cotransporter 2 (SGLT-2) inhibitors, metformin, insulin secretagogues, thiazolidinediones (TZDs), and insulin; - Any approved or unapproved weight loss drugs (such as orlistat, lorcaserin, phentermine/topiramate, and naltrexone/bupropion) or Chinese herbal medicines, health care products, meal replacements, etc., affecting body weight; - Use of any drugs that might significantly change body weights, including systemic (i.e., intravenous, oral, or intra-articular administration) glucocorticoids for more than 1 week; tricyclic antidepressants; antipsychotic or antiepileptic drugs (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valeric acid and its derivatives, lithium preparations, and thioridazine), etc.; 7. Subjects who meet any of the following criteria related to cardiac function: - History of myocardial infarction, coronary angioplasty or bypass graft, heart valve disorders or cardiac valve prostheses, clinically significant unstable arrhythmia, unstable angina, transient ischemic attack, cerebrovascular accident, etc., within 6 months before screening; - Class III or IV congestive cardiac failure according to New York Heart Association (NYHA) classification; - Subjects with serious arrhythmia requiring treatment (such as long QT syndrome) and not suitable for the clinical study as assessed by the investigator; - Poorly controlled hypertension before screening (i.e., systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg); - Presence of clinical abnormalities (e.g., QTcF > 450 msec, complete left bundle branch block, signs of acute or unexplained myocardial infarction, ST-segment changes suggestive of myocardial ischemia, second or third degree atrioventricular block, or serious bradyarrhythmia or tachyarrhythmia) by electrocardiography (ECG) at screening that might affect the safety of subjects or the interpretation of study results; - Resting heart rate > 100 beats/min; - Other cardiac function abnormalities with clinical significance judged by the investigator; 8. Currently with thyroid dysfunction that is not well controlled with a stable dose of medications, or with clinically significant abnormalities noted in thyroid function test results at screening; 9. History of medullary thyroid cancer, multiple endocrine neoplasia (MEN) syndrome type 2A or 2B or relevant family history (family history is defined as diseases in a first-degree relatives); 10. Subjects diagnosed with malignancies within 5 years before screening (except for cured cutaneous basal cell carcinoma or cervical carcinoma in situ); 11. History of acute or chronic pancreatitis, symptomatic gallbladder disease (such as multiple gallstones), pancreatic injury, and other high-risk factors that may lead to pancreatitis; 12. Subjects with clinically significant abnormal gastric emptying (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (active ulcer within 6 months), long-term use of drugs with direct effects on gastrointestinal motility (including but not limited to mosapride, cisapride, etc.), or gastrointestinal surgery (except for polypectomy and appendectomy) within 6 months before screening, who are not suitable for the clinical study as assessed by the investigator; 13. History of organ transplantation, or previous or current serious autoimmune diseases; 14. Subjects who have a history of major surgery within 6 months before screening, or plan to undergo surgery that might affect study completion or compliance; 15. Subjects with a history of moderate to severe depression and anxiety, or a history of serious mental illness, or a depression screening scale (PHQ-9) score = 15 at screening; 16. Subjects with previous suicidal tendency or suicidal behavior; 17. Subjects with any laboratory test parameter meeting any of the following criteria at screening: - Glycosylated hemoglobin (HbA1c) = 6.5%; - Fasting plasma glucose (FPG) = 7.0 mmol/L; - Glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 as calculated using the CKD-EPI formula; - Alanine aminotrans

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change in body weight

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with weight decrease = 5%;Absolute change in body weight;Absolute change in body mass index (BMI);Absolute change in waist circumference;Change in blood lipid profiles (TC, TG, LDL-C, and HDL-C);Change in fasting plasma glucose (FPG);Change in HbA1c (glycated haemoglobin);Change in fasting insulin;Change in fasting C-peptide