Merck Unveils Phase 3 Data: Oral PCSK9 Inhibitor Enlicitide Outperforms Rivals in Cholesterol Reduction

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Merck presented detailed Phase 3 CORALreef AddOn trial data at the American College of Cardiology (ACC.26) meeting, showing enlicitide reduced LDL-C by 64.6% in statin-treated adults with atherosclerotic cardiovascular disease, outperforming controls (bempedoic acid + ezetimibe at 36.5%)13.

Enlicitide achieved 54.6% reduction in ApoB (vs. 27.7% for bempedoic acid + ezetimibe) and 58.0% in non-HDL-C (vs. 31.8%)1.

This is the third successful Phase 3 trial (CORALreef AddOn, Lipids, HeFH), with enlicitide showing a favorable safety profile similar to placebo and high adherence despite empty-stomach dosing requirement12.

Enlicitide, an oral macrocyclic peptide PCSK9 inhibitor, could be the first approved oral option, potentially exceeding $2.8B in 2033 sales per analysts1.

Data presented March 30, 2026, at ACC.26; Merck plans regulatory submissions13.

Sources:

1. https://www.fiercebiotech.com/biotech/merck-dives-detailed-data-showing-pcsk9-pill-easily-outswims-rivals

2. https://www.merck.com/news/mercks-investigational-oral-pcsk9-inhibitor-enlicitide-decanoate-met-all-primary-and-key-secondary-endpoints-in-adults-with-hypercholesterolemia-in-pivotal-coralreef-lipids-study/

3. https://www.merck.com/news/merck-highlights-new-data-from-cardio-pulmonary-pipeline-at-acc-26-showcasing-commitment-to-advance-innovative-research/