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Clinical Trials in China / NCT07625774
Starting soon Phase 3

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

NCT07625774 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Suncadia Medicine Co., Ltd.
Phase
Phase 3
Started
2026-07
Last updated
2026-06-04

Condition(s) studied

Chronic Kidney Disease

Investigational drug(s) / intervention(s)

HRS-7535Placebo

HRS-7535: HRS-7535

Placebo: Placebo

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Tianjin Medical University General Hospital Tianjin Tianjin Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

More Shandong Suncadia Medicine Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07625774 on ClinicalTrials.gov ↗ ← All trials in China