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SOLID-DKD

CompletedPhase 2

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

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

Asset

KAI-7535 / HRS-7535

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

281

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

BMI ≤40HbA1c 6.5-10%eGFR ≥30UACR 300-3000

Primary endpoint

Ratio of UACR

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06415214
Org study IDHRS-7535-203

Timeline

Milestones

Study first posted2024-05-16actual
Study start2024-06-21actual
Primary completion2025-07-15actual
Study completion2025-07-25actual
Last update posted2026-01-05actual

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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;

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
6
Renal / kidney
3
Weight & body composition
1
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change from baseline in body weight at Week 16

Time frame:at Week 16

change from baseline, improvement

Glycemic / diabetes

6 endpoints
Secondary/protocol endpoint

Change from baseline in HbA1c at Week 16

Time frame:at Week 16

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:at Week 16

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in FPG at Week 16

Time frame:at Week 16

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in insulin at Week 16

Time frame:at Week 16

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in c-peptide at Week 16

Time frame:at Week 16

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects receiving glycemic rescue medicine at Week 16

Time frame:at Week 16

threshold achievement, improvement

Renal / kidney

3 endpoints
Primary/protocol endpoint

Ratio of UACR at week 16 to UACR at baseline

Time frame:at Week 16

ratio, improvement

Secondary/protocol endpoint

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

Time frame:at Week 16

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in eGFR at Week 16

Time frame:at Week 16

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

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

Time frame:at Week 16

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

24 hour urine analysis results at Week 16

Time frame:at Week 16

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.