A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetic Kidney Disease

HRS-7535-203

The study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed Phase II clinical study. The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetic kidney disease.

2024-06-01

2025-08-01

2025-09-01

Not yet recruiting

Early phase I

186

Inclusion Criteria: 1. Male or female subjects, 18-75 years of age at the time of signing informed consent; 2. Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2; 3. Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2; 4. Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators; 5. UACR ≥300 and \<3000 mg/g; 6. HbA1c ≥6.5% and ≤10.0%; 7. ACEI/ARB was used for ≥3 months and ACEI/ARB was stabilized at either the maximum recommended dose (reference to the drug label) or the maximum tolerated dose within 4 weeks; 8. Use hypoglycemic drugs for ≥3 months (the dosage of SGLT2i remains stable if used); 9. Able and willing to provide a written informed consent; Exclusion Criteria: 1. Have type 1 diabetes mellitus or specific type of diabetes; 2. Acute kidney injury or dialysis treatment within 6 months; 3. Kidney transplantation is planned during the trial; 4. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 5. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix; 6. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 7. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 186, 'type': 'ESTIMATED'}}

2024-05-23