Testing the oral drug HRS-7535 in adults with chronic kidney disease
Tests HRS-7535 against placebo in adults with chronic kidney disease.
Plain-language title generated from the registry record
Registry title: Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease
Key facts
- Where
- Hangzhou and Tianjin, ChinaSee the 2 sites
- Phase
- Phase 3
Where in China
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
- Tianjin Medical University General HospitalTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shandong Suncadia Medicine Co., Ltd.
- Trial code
- NCT07625774
- Record updated
- 4 June 2026
- Original description
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 careRead full original descriptionShow less
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: 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: 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; 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; 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); Any condition deemed inappropriate for participation in this clinical trial by the investigator.