HANSOH PHARMA PUBLISHED THE FIRST RANDOMIZED CLINICAL EVIDENCE OF FULAIMEI IN TREATING DIABETIC KIDNEY DISEASE
Results from a randomized clinical trial on Hansoh Pharma's Fulaimei (PEG loxenatide injection) for the treatment of patients with diabetic kidney disease (DKD) were recently published inFrontiers in Endocrinology. The data showed that PEG loxenatide is as effective as dapagliflozin in improving urine protein levels in patients with mild-to-moderate DKD and offers superior benefits in improving lipid profiles.
In this single-center, randomized, open-label clinical trial，106 patients with mild to moderate DKD and suboptimal glycemic control were recruited and randomly allocated to one of the two groups for treatment with either PEG loxenatide or dapagliflozinor, with the aim of evaluating the efficacy and safety of the two medications in these patients.The primary endpoint was the change in urinary albumin/creatinine ratio (UACR) from baseline at 24 weeks(1).
Results showed that after 24 weeks of treatment, the average UACR decreased by 29.3% compared to baseline in the PEG loxenatide group and 31.8% in the dapagliflozin group, with no statistical significance (p = 0.336). This implies that these two groups had comparable efficacy for proteinuria. The efficacy of the two groups was also comparable in terms of blood glucose reduction and weight loss, but the PEG loxenatide group was slightly superior in reducing fasting glucose (FPG) levels. Notably, the PEG loxenatide group demonstrated a more significant reduction in triglyceride (TG) levels (-0.56 vs -0.33 mmol/L, p = 0.023). These two groups were similar in other lipid and blood pressure indicators.The safety profile was also consistent with previous study findings, which displayed that the tolerability of PEG loxenatide group was more favorable, and no new safety events were identified(1).
DKD is a microvascular complication of diabetes mellitus that occurs in approximately 10-40% of diabetic patients, with clinical manifestations of persistent proteinuria and/or a progressive decline in glomerular filtration rate (GFR), which can ultimately lead to end-stage renal disease (ESRD).Furthermore, DKD markedly increases the risk of cardiovascular events and all causes of mortality in patients with type 2 diabetes(2).
SGLT2 inhibitors, such as dapagliflozin, have renoprotective and glucose-lowering effects, and have been endorsed by the national guideline recommendations as first-line glucose-lowering agents for the treatment of DKD(2). GLP-1 receptor agonists also improve renal outcomes in DKD(2), however, the efficacy and safety of PEG loxenatide in patients with DKD have not been reproted yet.
The data from this study provide an important evidence-based rationale for the use of PEG loxenatide in patients with DKD, which could be a new therapeutic option available for patients with mild to moderate DKD.
References:
（1） Cao Y, Cao S, Zhao J, Zhao J, Zhao Y and Liu Y (2024) Efficacy and safety of polyethylene glycol loxenatide in treating mild-to-moderate diabetic kidney disease in type 2 diabetes patients: a randomized, open-label, clinical trial.Front Endocrinol. 15:1387993.
（2） The Chinese Diabetes Society Microvascular Complications Study Group Clinical Guidelines for the Prevention and Treatment of Diabetic Kidney Disease in China [J] Chinese Journal of Diabetes 2019, 11(1) : 15-28.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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