Efficacy and Safety of HRS-7535 Tablets in Adults With Type 2 Diabetic Kidney Disease

Phase 2

Not yet recruiting

• Conditions: Type 2 Diabetic Kidney Disease
• Interventions: Drug: Placebo; Drug: HRS-7535

• Registration Number: NCT06415214
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Study Start: 2024-06
• Primary Completion: 2025-08
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A，Subjects will receive Placebo administered orally	Placebo	-
Group B，Subjects will receive HRS-7535 administered orally	HRS-7535	-
Group C，Subjects will receive escalated HRS-7535 administered orally	HRS-7535	-

Primary Outcome Measures

Name	Time	Method
Ratio of UACR at week 16 to UACR at baseline	at Week 16

Secondary Outcome Measures

Name	Time	Method
Change from baseline in c-peptide at Week 16	at Week 16
Change from baseline in eGFR at Week 16	at Week 16
Proportion of subjects with a 30% decrease in UACR from baseline at Week 16	at Week 16
Change from baseline in insulin at Week 16	at Week 16
Proportion of subjects receiving glycemic rescue medicine at Week 16	at Week 16
Change from baseline in FPG at Week 16	at Week 16
24 hour urine analysis results at Week 16	at Week 16
Change from baseline in HbA1c at Week 16	at Week 16
Change from baseline in body weight at Week 16	at Week 16
A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16	at Week 16
Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16	at Week 16