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HRS-7535

DRUG7 trials

Sponsors

Shandong Suncadia Medicine Co., Ltd.

Conditions

Chronic Kidney DiseaseChronic Weight ManagementDiabetic Kidney Disease, Type 2 DiabetesHealthy SubjectsHypertension With Overweight or ObesityType 2 Diabetes

Phase 1

A Phase I Single- and Multiple- Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects
NCT05347758
Shandong Suncadia Medicine Co., Ltd.Healthy Subjects
Start: 2022-05-01End: 2023-03-15Target: 106Updated: 2022-04-26

Phase 2

A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus
NCT05759897
Shandong Suncadia Medicine Co., Ltd.Type 2 Diabetes
Start: 2023-02-28End: 2024-01-04Target: 180Updated: 2023-03-08
Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
CompletedNCT06393348
Shandong Suncadia Medicine Co., Ltd.Type 2 Diabetes
Start: 2024-05-17End: 2025-03-13Updated: 2025-12-05
Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes
CompletedNCT06415214
Shandong Suncadia Medicine Co., Ltd.Diabetic Kidney Disease, Type 2 Diabetes
Start: 2024-06-21End: 2025-07-25Updated: 2026-01-05
Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects
CompletedNCT06671821
Shandong Suncadia Medicine Co., Ltd.Chronic Weight Management
Start: 2024-11-20End: 2025-09-28Updated: 2025-11-17

Phase 3

Phase III Study of HRS-7535 for Hypertension With Overweight or Obesity
RecruitingNCT07528027
Shandong Suncadia Medicine Co., Ltd.Hypertension With Overweight or Obesity
Start: 2026-05-29End: 2028-01-01Target: 648Updated: 2026-06-05
Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease
Not yet recruitingNCT07625774
Shandong Suncadia Medicine Co., Ltd.Chronic Kidney Disease
Start: 2026-07-01End: 2031-07-01Target: 3690Updated: 2026-06-04

Related Papers

HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin
JAMA Network Open2026-06-03
95-LB: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Novel Oral Small Molecule GLP-1 Receptor Agonist (HRS-7535) in Healthy Subjects —A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study
Diabetes2023-06-20