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

Sponsor
Shandong Suncadia Medicine Co., Ltd.
Study ID
NCT07625774
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HRS-7535 — DRUG
    HRS-7535
  • Placebo — DRUG
    Placebo

Study Details

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 Dates

First listed
Jun 4, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
May 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
3,690 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A, Participants will receive HRS-7535 tablets administered orally
  • Placebo Comparator: Group B, Participants will receive matching placebo tablets administered orally

Primary Outcome Measure

Time to first occurrence of any of the following renal composite endpoint events [ Time Frame: Up to approximately 4.8 years ]

Central Contacts

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