A Comprehensive Clinical and Pharmacological Monograph on Liraglutide (DB06655)

Executive Summary

Liraglutide is a long-acting, acylated glucagon-like peptide-1 (GLP-1) receptor agonist, a class of drugs also known as incretin mimetics. As a biotech product, it is synthesized as a lipopeptide with 97% amino acid homology to native human GLP-1, engineered with specific molecular modifications to achieve a prolonged half-life suitable for once-daily subcutaneous administration.[1] This agent has established a significant role in the management of metabolic disorders, marketed under two distinct brand names for separate, FDA-approved indications: Victoza® for the treatment of type 2 diabetes mellitus (T2DM) and for cardiovascular risk reduction, and Saxenda® for chronic weight management.[3]

The clinical efficacy of liraglutide is supported by a robust body of evidence from large-scale clinical trial programs. For T2DM, it provides potent glycemic control as an adjunct to diet and exercise and is recommended by major clinical bodies, such as the American Diabetes Association (ADA), as a first-line pharmacologic therapy (in combination with metformin) for patients with T2DM who have established atherosclerotic cardiovascular disease (ASCVD).[3] This recommendation is largely based on the landmark Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial. The LEADER trial demonstrated that liraglutide, when added to standard of care, significantly reduces the risk of the primary composite endpoint of major adverse cardiovascular events (MACE), including a notable reduction in cardiovascular death, in high-risk T2DM patients.[5]