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SOLID-DKD
CompletedPhase 2Efficacy 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
Lead sponsor
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 ≤40•HbA1c 6.5-10%•eGFR ≥30•UACR 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
1 endpointChange from baseline in body weight at Week 16
Time frame:at Week 16
change from baseline, improvement
Glycemic / diabetes
6 endpointsChange from baseline in HbA1c at Week 16
Time frame:at Week 16
change from baseline, improvement
Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16
Time frame:at Week 16
threshold achievement, improvement
Change from baseline in FPG at Week 16
Time frame:at Week 16
change from baseline, improvement
Change from baseline in insulin at Week 16
Time frame:at Week 16
change from baseline, improvement
Change from baseline in c-peptide at Week 16
Time frame:at Week 16
change from baseline, improvement
Proportion of subjects receiving glycemic rescue medicine at Week 16
Time frame:at Week 16
threshold achievement, improvement
Renal / kidney
3 endpointsRatio of UACR at week 16 to UACR at baseline
Time frame:at Week 16
ratio, improvement
Proportion of subjects with a 30% decrease in UACR from baseline at Week 16
Time frame:at Week 16
threshold achievement, improvement
Change from baseline in eGFR at Week 16
Time frame:at Week 16
change from baseline, improvement
Safety / tolerability / PK
1 endpointA summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16
Time frame:at Week 16
descriptive
Other (unclassified)
1 endpoint24 hour urine analysis results at Week 16
Time frame:at Week 16
descriptive
Provenance
Sources
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.