ArticleEuropean heart journal supplements : journal of the European Society of Cardiology2026
New frontiers in the treatment of hypercholesterolaemia: oral inhibition of PCSK9.
Article in European heart journal supplements : journal of the European Society of Cardiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
PCSK9 inhibitors represent a cornerstone of lipid-lowering therapy; however, the need for cost containment and simplified routes of administration has stimulated the development of oral small molecules and peptidomimetics capable of modulating or blocking the PCSK9-LDL receptor (LDL-R) interaction, inhibiting PCSK9 mRNA transcription, or preventing lysosomal degradation of the LDL-R. Agents in advanced development include enlicitide (MK-0616) and laroprovstat (AZD0780), while DC371739, NNC0385-0434 (development currently suspended), and CVI-LM001 should also be considered. Enlicitide decanoate, owing to improved intestinal permeability, significantly reduces free PCSK9 (>90%) and LDL-cholesterol (C) (≈60%) in Phase I-II studies, with excellent tolerability. Phase III trials (CORALreef-Lipids and CORALreef-HeFH) have confirmed LDL-C reductions of 55-60%, along with favourable effects on non-HDL-C, apolipoprotein B (apoB), and Lipoprotein(a) Lp(a), comparable to those achieved with monoclonal antibodies. AZD0780 demonstrates dose-dependent reductions in LDL-C (up to 50%) and potential synergism with rosuvastatin, whereas NNC0385-0434-despite documenting significant decreases in LDL-C and Lp(a)-has been discontinued. DC371739 (a dual PCSK9/ANGPTL3 inhibitor) and CVI-LM001 (a transcriptional modulator) may represent additional therapeutic perspectives. Overall, oral PCSK9 inhibitors show consistent efficacy and favourable safety profiles, positioning them as next-generation lipid-lowering therapies, pending cardiovascular outcome data from ongoing studies.
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