Development and validation of a novel, commerical ELISA kit for the quantification of Tirzepatide in biological samples 3472

Abstract Description Tirzepatide, a dual-agonist targeting GLP-1 and GIP receptors, addresses the global rise of type 2 diabetes and obesity, which affected over 800 million adults in 2024. By combining GLP-1-driven reductions in glucagon secretion and appetite with GIP’s enhancement of insulin secretion and lipid metabolism, Tirzepatide improves glycemic control and weight loss. Clinical trials have shown its superior efficacy over GLP-1 agonist drugs, with greater HbA1c reductions, weight loss, and enhanced tolerability due to GIP’s role in mitigating GLP-1-related nausea. Tirzepatide also holds promise for reducing cardiovascular risks and may lead to new therapeutic applications. Characterizing the binding of Tirzepatide to both GLP-1 and GIP receptors is critical for pharmacokinetic studies. Although LC-MS is the standard method for quantification, ELISA offeres better sensitivity and specificity. Many labs develop in-house ELISA methods - but commercially ready ELISA offer standardised validation, and reproducibility, alongside cross-laboratory consistency, ensuring reliable and consistent results for regulatory purposes. This study developed a novel immunoassay using monoclonal antibodies for selective binding to Tirzepatide, validated for specificity, accuracy, and precision. The assay demonstrated excellent performance with a range of 50 ng/ml to 4000 ng/ml and extensive validation against Mounjaro (Eli Lilly), providing a valuable tool for therapeutic studies and additional research. Topic Categories Technological Innovations in Immunology (TECH)