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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Evaluate the Efficacy and Safety of HRS-7535 in Participants With Chronic Kidney Disease

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

Inclusion Criteria:

1. Male or female subjects, Age ≥ 18 years at the time of signing informed consent;
2. Clinically diagnosed with chronic kidney disease at screening;
3. CKD treatment plan consistent with current clinical guidelines or local standard of care;
4. eGFR ≥ 20 mL/min/1.73 m² and UACR meeting protocol-specified criteria at screening and prior to randomization;
5. Able and willing to provide a written informed consent;

Exclusion Criteria:

1. Uncontrolled severe hypertension prior to randomization (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg); or systolic blood pressure < 90 mmHg.
2. Body mass index (BMI) < 20 kg/m² at screening and prior to randomization.
3. Prior history of renal transplantation, or planned renal transplantation during the trial;
4. History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
5. History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatable gallbladder disease (excluding cholecystectomy recipients);
6. Occurrence of acute kidney injury or receipt of dialysis treatment within 3 months prior to screening or randomization;
7. 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;
8. Any condition deemed inappropriate for participation in this clinical trial by the investigator.