ArticleEClinicalMedicine2026
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.
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: The efficacy of non-peptide small-molecule glucagon-like peptide-1 (GLP-1) receptor agonists in diabetic kidney disease remains uncertain, particularly as add-on therapy to contemporary high-intensity treatments. We assessed HRS-7535, a novel oral small-molecule GLP-1 receptor agonist, in this population. Methods: SOLID-DKD was a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial conducted at 72 clinical sites in China. Adults with diabetic kidney disease (urinary albumin-to-creatinine ratio [UACR] 300-<3000 mg/g; estimated glomerular filtration rate [eGFR] ≥30 mL/min per 1.73 m Findings: Between June 21, 2024, and March 30, 2025, 281 participants were randomised; 280 received at least one dose (30 mg: n = 93; 90 mg: n = 94; placebo: n = 93). Baseline median UACR was 763 mg/g; 181 (64.6%) participants were receiving SGLT2 inhibitors and 68 (24.3%) were receiving finerenone. At week 16, the placebo-corrected reduction in UACR with 90 mg was -32% (95% CI -43 to -18; treatment-policy estimand [intention-to-treat]) and -38% (-49 to -24; efficacy estimand [on-treatment analysis]); with 30 mg, -14% (-29 to 4) and -19% (-34 to -2), respectively. Compared with placebo, the mean difference in glycated haemoglobin with HRS-7535 90 mg was -1.09% (-1.32 to -0.86) and in body weight was -2.95% (-3.94 to -1.95). Adverse events were primarily mild-to-moderate gastrointestinal events during dose escalation. Serious adverse events occurred in 5 (5.4%), 4 (4.3%), and 2 (2.2%) participants in the 30 mg, 90 mg, and placebo groups. Discontinuation due to adverse events occurred in 3 (3.2%), 1 (1.1%), and 0 participants, respectively. No deaths occurred. Interpretation: HRS-7535 dose-dependently reduced albuminuria in patients with diabetic kidney disease receiving intensive contemporary therapy, with a short-term safety profile consistent with the GLP-1 receptor agonist class, supporting its evaluation in phase 3 renal outcome trials. Funding: Jiangsu Hengrui Pharmaceuticals.
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