Integrated Population Pharmacokinetic and Exposure-Response Modeling of Enlicitide in Hypercholesterolemia Patients Supports Clinical Dose Recommendation Across Patient Subgroups

Authors: Skataric M, Zhou S, Jaworowicz DJ, Gaurav M, Mehrani R, Johns DG, Banka P, Kothare PA, Gheyas F
Conference: PAGE
Keywords: cardiovascular, clinical doses, exposure-response modeling, hypercholesterolemia, Injectables, lipoprotein cholesterol, modeling and simulation, PopPK, population pharmacokinetic

Background

Despite the well-established cardiovascular benefit of  low-density lipoprotein cholesterol (LDL-C) lowering, real-world use of  PCSK9-targeted therapies remains limited, in part due to reliance on injectable formulations.

Enlicitide decanoate is a novel, oral macrocyclic peptide proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor developed as a once-daily oral LDL-C-lowering therapy to enable robust LDL-C reduction and reduction of cardiovascular risk, offering potential for improved accessibility and adherence [1].

35th PAGE Meeting, June 2-5, 2026, Dubrovnik, Croatia

By Maja Skataric, Susan Zhou, David Jaworowicz, Mitali Gaurav, Ramin Mehrani, Douglas G. Johns, Puja Banka, Islam R. Younis, Prajakti A. Kothare, Ferdous Gheyas