Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease
NCT07625774 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3690
Last updated 2026-06-04
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
Interventions
- DRUG
-
HRS-7535
HRS-7535
- DRUG
-
Placebo
Sponsors & Collaborators
-
Shandong Suncadia Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2031-05-31
- Completion
- 2031-07-31
Countries
- China
Study Locations
More Related Trials
-
A Clinical Study of Mass Balance of [14C]HRS-7535
NCT06819488 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects
NCT01866748 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Diabetic Kidney Disease
NCT01847313 ·Status: COMPLETED ·Phase: PHASE3
-
Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
NCT06582875 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Weekly Oral Dose of Ecnoglutide (VRB-101) for Weight Maintenance in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
NCT07553299 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment
NCT02827708 ·Status: COMPLETED ·Phase: PHASE3
-
A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese
NCT04016974 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants
NCT07443059 ·Status: RECRUITING ·Phase: PHASE1
-
Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy
NCT06555146 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Clinical, Morphometric and Biochemical Effects on Adiposopathy Associated With the Use of GLP-1RA in CKD
NCT07309094 ·Status: RECRUITING
-
Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures
NCT07092605 ·Status: ENROLLING_BY_INVITATION ·Phase: EARLY_PHASE1
-
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes
NCT01686945 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy
NCT04741074 ·Status: TERMINATED ·Phase: PHASE3
-
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
NCT03819153 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea
NCT01557166 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Liraglutide on Clock Genes
NCT02783196 ·Status: UNKNOWN ·Phase: NA
-
Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans
NCT06333496 ·Status: COMPLETED ·Phase: NA
-
Liraglutide Treatment to Patients With Severe Renal Insufficiency
NCT01394341 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
NCT05936151 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
NCT05536804 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis
NCT07617155 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)
NCT04865770 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions
NCT06801015 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Comparison of Two Liraglutide Formulations in Healthy Subjects
NCT01515579 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters
NCT02490176 ·Status: UNKNOWN ·Phase: NA