## Protocol Section
### Identification Module
**NCT ID:** NCT06415214

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

**Official Title:** 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

#### Organization Study ID Info
**ID:** HRS-7535-203
#### Organization
**Class:** INDUSTRY
**Full Name:** Shandong Suncadia Medicine Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shandong Suncadia Medicine Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Type 2 Diabetic Kidney Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 186

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Placebo

**Label:** Group A，Subjects will receive Placebo administered orally

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: HRS-7535

**Label:** Group B，Subjects will receive HRS-7535 administered orally

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: HRS-7535

**Label:** Group C，Subjects will receive escalated HRS-7535 administered orally

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A，Subjects will receive Placebo administered orally

**Description:** Placebo

**Name:** Placebo

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group B，Subjects will receive HRS-7535 administered orally

- Group C，Subjects will receive escalated HRS-7535 administered orally

**Description:** HRS-7535

**Name:** HRS-7535

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Ratio of UACR at week 16 to UACR at baseline

**Time Frame:** at Week 16

#### Secondary Outcomes

**Measure:** 24 hour urine analysis results at Week 16

**Time Frame:** at Week 16

**Measure:** Proportion of subjects with a 30% decrease in UACR from baseline at Week 16

**Time Frame:** at Week 16

**Measure:** Change from baseline in eGFR at Week 16

**Time Frame:** at Week 16

**Measure:** Change from baseline in HbA1c at Week 16

**Time Frame:** at Week 16

**Measure:** Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16

**Time Frame:** at Week 16

**Measure:** Change from baseline in FPG at Week 16

**Time Frame:** at Week 16

**Measure:** Change from baseline in insulin at Week 16

**Time Frame:** at Week 16

**Measure:** Change from baseline in c-peptide at Week 16

**Time Frame:** at Week 16

**Measure:** Change from baseline in body weight at Week 16

**Time Frame:** at Week 16

**Measure:** Proportion of subjects receiving glycemic rescue medicine at Week 16

**Time Frame:** at Week 16

**Measure:** A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16

**Time Frame:** at Week 16

### Eligibility Module

**Eligibility Criteria:** 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;

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** liang.peng.lp1@hengrui.com

**Name:** Liang Peng

**Phone:** 0518-82342973

**Role:** CONTACT

**Contact 2:**

**Email:** tingyu.dong@hengrui.com

**Name:** Tingyu Dong

**Phone:** 0518-82342973

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000048909

- Term: Diabetes Complications

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M7123

- Name: Diabetic Nephropathies

- Relevance: HIGH

- As Found: Diabetic Kidney Disease

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000003928

- Term: Diabetic Nephropathies

### Misc Info Module

- Version Holder: 2024-05-31
