Diabetic Kidney Disease, Type 2 DiabetesPhase 2SOLID-DKDNCT06415214
Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes
A Phase 2 study testing HRS-7535 in people with Diabetic Kidney Disease, Type 2 Diabetes, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial 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 diabetic kidney disease in type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Kidney Disease, Type 2 Diabetes
- What is being tested?
- HRS-7535
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 281 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2024to 25 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18-75 years of age at the time of signing informed consent;
- Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2;
- Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2;
- Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators;
- UACR ≥300 and <3000 mg/g;
- HbA1c ≥6.5% and ≤10.0%;
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- 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;
- Use hypoglycemic drugs for ≥3 months (the dosage of SGLT2i remains stable if used);
- Able and willing to provide a written informed consent;
Who cannot join
- Have type 1 diabetes mellitus or specific type of diabetes;
- Acute kidney injury or dialysis treatment within 6 months;
- Kidney transplantation is planned during the trial;
- History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- 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;
- history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: 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
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 diabetic kidney disease in type 2 diabetes.
- Conditions
- Diabetic Kidney Disease, Type 2 Diabetes
- Being tested
- Placebo, HRS-7535
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
HRS-7535Drug
HRS-7535
| Study group | Role | What they receive |
|---|---|---|
| Group A，Subjects will receive Placebo administered orally | Placebo comparator | Not described Receives: Drug: Placebo |
| Group B，Subjects will receive HRS-7535 administered orally | Experimental | Not described Receives: Drug: HRS-7535 |
| Group C，Subjects will receive escalated HRS-7535 administered orally | Experimental | Not described Receives: Drug: HRS-7535 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of UACR at week 16 to UACR at baseline
Measured: at Week 16
Secondary outcomes (11)
24 hour urine analysis results at Week 16
Measured: at Week 16
Proportion of subjects with a 30% decrease in UACR from baseline at Week 16
Measured: at Week 16
Change from baseline in eGFR at Week 16
Measured: at Week 16
Change from baseline in HbA1c at Week 16
Measured: at Week 16
Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16
Measured: at Week 16
Change from baseline in FPG at Week 16
Measured: at Week 16
Change from baseline in insulin at Week 16
Measured: at Week 16
Change from baseline in c-peptide at Week 16
Measured: at Week 16
Change from baseline in body weight at Week 16
Measured: at Week 16
Proportion of subjects receiving glycemic rescue medicine at Week 16
Measured: at Week 16
A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16
Measured: at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start21 Jun 2024
- Primary completion15 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney Disease, Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415214
- Sponsor's protocol ID
- HRS-7535-203
- Acronym
- SOLID-DKD
- Status last verified
- May 2025
- First submitted
- 10 May 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lv R, Peng L, Xu Y, Du X, Liu H, Wu H, Zhang Y, Li Q, Jiao X, Piao C, Yang S, Lin X, Li L, Ye Z, Chen J; SOLID-DKD Investigator Groupl; SOLID-DKD Investigator Group. Efficacy and safety of HRS-7535, an oral small-molecule GLP-1 receptor agonist, in patients with diabetic kidney disease (SOLID-DKD): a randomised, double-blind, placebo-controlled, phase 2 trial. EClinicalMedicine. 2026 Jul 9;97:104045. doi: 10.1016/j.eclinm.2026.104045. eCollection 2026 Jul.
PubMed 42472282
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06415214
- Acronym / sponsor ID
- SOLID-DKD / HRS-7535-203
- Conditions
- Diabetic Kidney Disease, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 diabetic kidney disease in type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A，Subjects will receive Placebo administered orally | Placebo comparator | Drug: Placebo |
| Group B，Subjects will receive HRS-7535 administered orally | Experimental | Drug: HRS-7535 |
| Group C，Subjects will receive escalated HRS-7535 administered orally | Experimental | Drug: HRS-7535 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects, 18-75 years of age at the time of signing informed consent;
- Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2;
- Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2;
- Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators;
- UACR ≥300 and <3000 mg/g;
Key exclusion criteria (7 listed)
- Have type 1 diabetes mellitus or specific type of diabetes;
- Acute kidney injury or dialysis treatment within 6 months;
- Kidney transplantation is planned during the trial;
- History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Drug | Group A，Subjects will receive Placebo administered orally |
| HRS-7535HRS-7535 | Drug | Group B，Subjects will receive HRS-7535 administered orally, Group C，Subjects will receive escalated HRS-7535 administered orally |
Primary outcome
Ratio of UACR at week 16 to UACR at baseline
Time frame: at Week 16
11 secondary outcomes
24 hour urine analysis results at Week 16
Time frame: at Week 16
Proportion of subjects with a 30% decrease in UACR from baseline at Week 16
Time frame: at Week 16
Change from baseline in eGFR at Week 16
Time frame: at Week 16
Change from baseline in HbA1c at Week 16
Time frame: at Week 16
Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16
Time frame: at Week 16
Change from baseline in FPG at Week 16
Time frame: at Week 16
Change from baseline in insulin at Week 16
Time frame: at Week 16
Change from baseline in c-peptide at Week 16
Time frame: at Week 16
Change from baseline in body weight at Week 16
Time frame: at Week 16
Proportion of subjects receiving glycemic rescue medicine at Week 16
Time frame: at Week 16
A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16
Time frame: at Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Derived from this study: PubMed 42472282Lv R, Peng L, Xu Y, Du X, Liu H, Wu H, Zhang Y, Li Q, Jiao X, Piao C, Yang S, Lin X, Li L, Ye Z, Chen J; SOLID-DKD Investigator Groupl; SOLID-DKD Investigator Group. Efficacy and safety of HRS-7535, an oral small-molecule GLP-1 receptor agonist, in patients with diabetic kidney disease (SOLID-DKD): a randomised, double-blind, placebo-controlled, phase 2 trial. EClinicalMedicine. 2026 Jul 9;97:104045. doi: 10.1016/j.eclinm.2026.104045. eCollection 2026 Jul.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-7535 in people with Diabetic Kidney Disease, Type 2 Diabetes, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of UACR at week 16 to UACR at baseline (time frame: at Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06415214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.