HRS-7535 cut albuminuria 32% versus placebo in diabetic kidney disease trial
-DKD, a 281-patient phase 2 trial in China, found the oral GLP-1 agonist lowered UACR on top of SGLT2 inhibitors and finerenone, at the cost of more gastrointestinal adverse events.
Executive Summary
- A phase 2 randomized, double-blind, placebo-controlled trial evaluated whether an oral small-molecule GLP-1 receptor agonist could lower albuminuria in patients with diabetic kidney disease already receiving intensive standard therapy.
- The higher of two tested doses produced a dose-dependent reduction in urinary albumin-to-creatinine ratio against placebo, alongside improvements in glycated hemoglobin and body weight.
- The albuminuria benefit came with a gastrointestinal tolerability signal typical of the GLP-1 receptor agonist class, including more treatment discontinuations on active drug than placebo.
- The result supports moving this oral GLP-1 agonist into a larger renal outcomes trial to test whether the albuminuria reduction translates into protection against kidney function loss over time.
The stake
Diabetic kidney disease already treated with SGLT2 inhibitors and, increasingly, the nonsteroidal mineralocorticoid receptor antagonist finerenone still carries a residual risk of progression, and whether a GLP-1 receptor agonist adds further protection on top of that intensive regimen had remained unresolved. -DKD tested HRS-7535, an oral small-molecule GLP-1 receptor agonist, against that open question in a population already receiving modern background care. Baseline urinary albumin-to-creatinine ratio (UACR) across the trial was 763 mg/g, and 64.6% of participants were on an SGLT2 inhibitor while 24.3% were on finerenone at enrollment, meaning the trial tested an add-on effect rather than a treatment-naive population. EfficacyEfficacy 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.Jul 19, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
How it was done
-DKD (NCT06415214) was a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial conducted at 72 sites in China. Adults with diabetic kidney disease, defined by UACR of 300 to under 3,000 mg/g and estimated glomerular filtration rate of at least 30 mL/min per 1.73 m2, were randomized 1:1:1 to once-daily oral HRS-7535 at 30 mg, 90 mg, or placebo for 16 weeks, stratified by baseline UACR and concomitant SGLT2 inhibitor and finerenone use. The primary endpoint was the relative change in UACR from baseline to week 16. Between June 21, 2024 and March 30, 2025, 281 participants were randomized and 280 received at least one dose (93 on 30 mg, 94 on 90 mg, 93 on placebo). NCT06415214+1Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 DiabetesNCT06415214Efficacy 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.Jul 19, 2026
The result
At week 16, the placebo-corrected reduction in UACR with the 90 mg dose was 32% by intention-to-treat analysis (95% CI, -43 to -18) and 38% by on-treatment analysis (95% CI, -49 to -24). The 30 mg dose showed smaller reductions of 14% by intention-to-treat (95% CI, -29 to 4, which crosses zero) and 19% by on-treatment analysis (95% CI, -34 to -2). Beyond the kidney endpoint, the 90 mg dose produced a mean difference versus placebo of -1.09 percentage points in glycated hemoglobin (95% CI, -1.32 to -0.86) and -2.95% in body weight (95% CI, -3.94 to -1.95), extending the drug's metabolic effect beyond the renal measure the trial was designed to test. EfficacyEfficacy 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.Jul 19, 2026
Safety
Adverse events were primarily mild-to-moderate gastrointestinal events occurring during dose escalation, a pattern consistent with the known tolerability profile of the GLP-1 receptor agonist class. Serious adverse events occurred in 5 of 93 participants (5.4%) on 30 mg, 4 of 94 (4.3%) on 90 mg, and 2 of 93 (2.2%) on placebo. Discontinuation due to adverse events occurred in 3 participants (3.2%) on 30 mg, 1 (1.1%) on 90 mg, and none on placebo, with no deaths reported. EfficacyEfficacy 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.Jul 19, 2026
Where this sits
Diabetic kidney disease trials in the small-molecule GLP-1 class remain sparse: the competitive field surrounding this trial is populated mostly by small molecules in adjacent diabetic eye disease (diabetic macular edema, diabetic retinopathy) rather than direct renal comparators, and by antibody- and protein-based VEGF therapies approved for those eye conditions rather than for kidney disease. The same sponsor has since advanced HRS-7535 into a phase 3 renal composite-endpoint trial with a projected 2031 completion, indicating the phase 2 albuminuria signal was judged sufficient to warrant that step.
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