Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

Prior treatment

• History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
• history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
• Surgery is planned during the trial;

Other illness

• Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;

Other

• Have type 1 diabetesmellitus;
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

• Male or female subjects, 18-75 years of age at the time of signing informed consent;
• Have T2DM (based on the 2020 Chinese Diabetes Society \[CDS\] diagnostic criteria)
• HbA1c为7.5%≤HbA1c≤11.0% at the screening visit；
• FPG≤15 mmol/L at the screening visit;
• Have been treated with an SGLT2i with metformin, for at least 8 weeks;
• At screening and random visit, 20.0 ≤BMI≤ 35.0 kg/m2;
• Able and willing to provide a written informed consent