This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group and event-driven phase III clinical trial. The aim of this trial is to confirm the superiority of HRS-7535 over placebo in reducing the risks of renal outcomes and cardiovascular death among participants with chronic kidney disease (CKD) on the basis of standard of care
Male or female subjects, Age ≥ 18 years at the time of signing informed consent;
Clinically diagnosed with chronic kidney disease at screening;
CKD treatment plan consistent with current clinical guidelines or local standard of care;
eGFR ≥ 20 mL/min/1.73 m² and UACR meeting protocol-specified criteria at screening and prior to randomization;
Uncontrolled severe hypertension prior to randomization (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg); or systolic blood pressure < 90 mmHg.
Body mass index (BMI) < 20 kg/m² at screening and prior to randomization.
Prior history of renal transplantation, or planned renal transplantation during the trial;
History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).