Merck has announced that its investigational, once-daily, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, enlicitide decanoate, demonstrated a statistically-significant reduction in low-density cholesterol (LDL-C) in its latest phase 3 trial.
If approved, enlicitide it will become the first oral PCSK9 inhibitor for patients with hypercholesterolemia who have a history of or are at risk for atherosclerotic cardiovascular disease (ASCVD).
The CORALreef AddOn trial is the third phase 3 study to achieve positive results. The active comparator study compared the efficacy of enlicitide to three guideline-recommended oral non-statin therapies at day 56. In all conditions, patients received background statins. Enlicitide reduced LDL-C by 64.6% from baseline and demonstrated a reduction of 56.7% versus bempedoic acid, 36.0% versus ezetimibe, and 28.1% versus bempedoic acid with ezetimibe. It also had a safety profile consistent with other phase 3 trials.