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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetic Kidney Disease
• Intervention / Treatment: Drug: Placebo; Drug: HRS-7535

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liang Peng; Phone Number: 0518-82342973; Email: liang.peng.lp1@hengrui.com
• Study Contact Backup: Name: Tingyu Dong; Phone Number: 0518-82342973; Email: tingyu.dong@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A，Subjects will receive Placebo administered orally	Drug: Placebo; Placebo
Experimental: Group B，Subjects will receive HRS-7535 administered orally	Drug: HRS-7535; HRS-7535
Experimental: Group C，Subjects will receive escalated HRS-7535 administered orally	Drug: HRS-7535; HRS-7535

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of UACR at week 16 to UACR at baseline	at Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
24 hour urine analysis results 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 eGFR at Week 16	at Week 16
Change from baseline in HbA1c at Week 16	at Week 16
Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16	at Week 16
Change from baseline in FPG at Week 16	at Week 16
Change from baseline in insulin at Week 16	at Week 16
Change from baseline in c-peptide at Week 16	at Week 16
Change from baseline in body weight at Week 16	at Week 16
Proportion of subjects receiving glycemic rescue medicine 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

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: HRS-7535-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No