Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Chronic Kidney Disease
In brief
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
Key facts
- Study ID
- NCT07625774
- Run by
- Shandong Suncadia Medicine Co., Ltd.
- People needed
- 3690
- Starts
- 2026-07-01
- Expected to finish
- 2031-07-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
Full record on ClinicalTrials.gov
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