Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease

Inclusion criteria

• 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;
• Able and willing to provide a written informed consent;

Exclusion criteria

• 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).
• History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatable gallbladder disease (excluding cholecystectomy recipients);
• Occurrence of acute kidney injury or receipt of dialysis treatment within 3 months prior to screening or randomization;
• Presence of severe gastrointestinal diseases within 3 months prior to screening or randomization, or a history of major gastrointestinal surgery affecting gastric accommodation or gastric emptying;
• Any condition deemed inappropriate for participation in this clinical trial by the investigator.