A Study of VCT220 Tablets in Adults With Type 2 Diabetes and Inadequate Blood Glucose Control

Prior treatment

• Previous diagnosis or suspicion of type 1 diabetes, other specific types of diabetes, or secondary diabetes.
• Acute complications of diabetes within 6 months before screening, including diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state.
• A Level 3 hypoglycemic event or at least three hypoglycemic events within 6 months before screening.
• Heart failure of New York Heart Association Class III or IV, unstable angina, stroke, myocardial infarction, or coronary revascularization within 6 months before screening; or planned coronary, carotid, or peripheral arterial revascularization at screening.
• Acute infection within 2 weeks before screening.
• Any malignancy within the previous 5 years or currently, except cured basal cell carcinoma of the skin or cervical carcinoma in situ.
• Previous discontinuation of a GLP-1 RA because of safety or tolerability concerns.
• Positive hepatitis B surface antigen at screening, except when quantitative hepatitis B virus DNA is below the lower limit of the assay reference range and the participant is not receiving anti-hepatitis B medication at screening; or positive hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis antibody.
• History of alcohol or drug abuse within 3 months before screening. Alcohol abuse is defined as more than 7 units per week; one unit is 360 mL of beer containing 5% alcohol, 45 mL of spirits containing 40% alcohol, or 150 mL of wine containing 12% alcohol.
• Treatment with any other investigational product within 3 months or 5 half-lives before screening, whichever is longer, or plans to participate in another clinical trial during this study.

Other illness

• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• History or current presence of severe gastrointestinal disease or relevant surgery, including acute or chronic pancreatitis, hepatitis, cholecystitis (except after cholecystectomy), or intestinal obstruction.
• History or current presence of a condition that may require repeated or long-term systemic glucocorticoid therapy, such as systemic lupus erythematosus, inflammatory bowel disease, or asthma. Topical, intraocular, and intranasal glucocorticoids are excluded from this restriction.
• Known or suspected allergy to VCT220 tablets, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or excipients.
• Significantly active or unstable major depressive disorder or another severe psychiatric disorder within 2 years before screening, or any history of attempted suicide.

Lab values

• A hematologic disorder or other condition at screening that may affect HbA1c measurement, including known hemoglobinopathy, hemolytic anemia, sickle cell anemia, blood transfusion within 3 months before screening, or severe blood loss within that period.
• Any of the following local laboratory or 12-lead electrocardiogram findings during screening:
  • Fasting plasma glucose \>11.1 mmol/L.
  • Thyroid-stimulating hormone \>6.0 mIU/L or \<0.4 mIU/L.
  • Alanine aminotransferase or aspartate aminotransferase ≥2 times the upper limit of normal (ULN), or total bilirubin ≥2 × ULN.
  • Fasting triglycerides \>5.65 mmol/L.
  • Serum amylase or lipase ≥1.5 × ULN.
  • Estimated glomerular filtration rate \<60 mL/min/1.73 m².
  • Calcitonin ≥50 ng/L.
  • Hemoglobin \<110 g/L in males or \<100 g/L in females.
  • Electrocardiographic heart rate \<55 or \>110 beats/minute.
  • Second- or third-degree atrioventricular block, long QT syndrome, QTcF \>450 ms in males or \>470 ms in females, left bundle branch block, complete right bundle branch block, pre-excitation syndrome, or other clinically significant arrhythmia, except asymptomatic sinus arrhythmia.
• Insulin treatment within 3 months before screening, or treatment with any glucose-lowering medication other than metformin or an SGLT2 inhibitor during that period, including traditional Chinese medicines used to lower blood glucose.

Other

• History or current presence of proliferative retinopathy or maculopathy, painful diabetic neuropathy, diabetic foot ulceration, or intermittent claudication.
• Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
• Pregnancy or breastfeeding; a male or female participant of reproductive potential unwilling to use highly effective contraception throughout the study and for 3 months after the last dose; plans to conceive or donate sperm or oocytes during that period; or a positive pregnancy test during screening.
• An employee of the sponsor, a study site, or the contract research organization, or an immediate family member of such an employee.
• Considered unsuitable for study participation by the study site.

• Male or female participants aged 18 to 65 years, inclusive, at the time of informed consent.
• Type 2 diabetes mellitus diagnosed at least 3 months before screening according to the Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 edition), and meeting one of the following: (a) management with diet and exercise alone for at least 3 months before screening; or (b) oral metformin at a stable dose of ≥1500 mg/day or a maximum tolerated dose of ≥1000 mg/day, alone or with an SGLT2 inhibitor at a stable dose, for at least 8 weeks before screening.
• HbA1c of 7.5% to 10.5%, inclusive, at screening, as measured by the local laboratory.
• Body weight ≥50 kg and body mass index of 19 to 35 kg/m², inclusive.
• Self-reported or documented body weight change of no more than 5% within the 3 months before screening.
• Willing and able to maintain a stable residence, remain contactable, and maintain a regular daily routine and diet and exercise management throughout the study.
• Fully understands the study procedures, can communicate effectively with the investigator, understands and can comply with study requirements, and is willing to sign the informed consent form.