NCT07625774Not yet recruitingPhase 3
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
Shandong Suncadia Medicine Co., Ltd.2 sites in 1 country3,690 target enrollmentStarted: July 1, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 3,690
- Locations
- 2
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Study Sites (2)
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