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

NCT07625774 | Not Yet Recruiting Phase 3

• 1 other identifier: HRS-7535-307
• Study Type: interventional
• Target: 3,690
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Time to first occurrence of any of the following renal composite endpoint events

  1. Death due to renal disease； 2. Cardiovascular death; 3. Renal replacement therapy (maintenance dialysis for at least 4 weeks or renal transplantation); 4. Sustained eGFR \< 15 mL/min/1.73 m² for at least 4 weeks; 5. Sustained decline of ≥40% in eGFR from baseline for at least 4 weeks;

  Up to approximately 4.8 years

Secondary Outcomes (5)

• Annual rate of change in estimated glomerular filtration rate (eGFR) from baseline to 24 Month of treatment;

  From baseline to Month 24

• Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline at Month 9 of treatment;

  At Month 9

• Change in systolic blood pressure from baseline at Month 9 of treatment.

  At Month 9

• Time to first diagnosis of diabetes for participants without diabetes at baseline;

  Up to approximately 4.8 years

• Time to first occurrence of any cardiovascular composite endpoint event (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke).

  Up to approximately 4.8 years

Study Arms (2)

Group A, Participants will receive HRS-7535 tablets administered orally

EXPERIMENTAL

Drug: HRS-7535

Group B, Participants will receive matching placebo tablets administered orally

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS-7535 DRUG

HRS-7535

Group A, Participants will receive HRS-7535 tablets administered orally

Placebo DRUG

Placebo

Group B, Participants will receive matching placebo tablets administered orally

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (2)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liang Peng

CONTACT

0518-82342973; liang.peng.lp1@hengrui.com

Chen Xu

CONTACT

0518-82342973; chen.xu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

CN (2)