Jiangsu Hansoh Pharmaceutical Co., Ltd, a leading pharmaceutical company based in China, has published the results of a clinical study for its polyethylene glycol (PEG) loxenatide—a Category 1 novel chemical drug—in the treatment of diabetes nephropathy (DKD) in the Frontiers in Endocrinology journal. The study’s data indicate that loxenatide is as effective as dapagliflozin in treating DKD and shows superior improvement in lipid levels.
The single-center, randomized, open-label study involved 106 patients with mild to moderate DKD and poor blood glucose control. Participants were assigned to receive either loxenatide or dapagliflozin to assess the efficacy and safety of both drugs. The primary endpoint was the change in urinary albumin/creatinine ratio (UACR) from baseline at 24 weeks. DKD, a microvascular complication of diabetes, affects approximately 10% to 40% of diabetes patients, presenting as continuous proteinuria and/or a gradual decline in glomerular filtration rate (GFR), potentially leading to end-stage renal disease (ESRD). Furthermore, DKD significantly increases the risk of cardiovascular events and all-cause mortality in patients with type 2 diabetes. This trial provides the first clinical evidence of loxenatide’s efficacy in treating diabetes nephropathy.
The results showed that after 24 weeks, the UACR for both the loxenatide and dapagliflozin groups decreased by an average of 29.3% and 31.8% from baseline, respectively, with no statistically significant difference (p=0.336), indicating comparable efficacy in improving urinary protein. Both groups also demonstrated similar efficacy in reducing blood sugar levels and weight loss, with loxenatide showing a slightly better trend in reducing fasting blood glucose (FPG) levels. Notably, the loxenatide group experienced a more significant decrease in triglyceride (TG) levels (-0.56 vs -0.33 mmol/L, p=0.023). The two groups showed similar results in other blood lipid and blood pressure indicators. In terms of safety, the drug showed good overall tolerability, consistent with previous research, and no new safety events were identified.
Loxenatide is recognized as China’s first innovative glucagon-like peptide-1 (GLP-1) receptor agonist and the world’s first pegylated GLP-1 drug. It received its initial marketing approval in China in May 2019 for improving glycemic control in adults with type 2 diabetes.- Flcube.com
