Merck's Enlicitide Shows Promising Results In Phase 3 CORALreef Lipids Trial

(RTTNews) - Merck & Co Inc. (MRK) has unveiled the first results from its pivotal Phase 3 CORALreef Lipids trial, highlighting the efficacy of enlicitide decanoate, an investigational once-daily oral PCSK9 inhibitor. The treatment demonstrated a statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) of 55.8% at week 24, with a post-hoc reanalysis showing an even greater reduction of 59.7% compared to placebo.

The trial enrolled adults with or at risk for atherosclerotic cardiovascular disease (ASCVD), including those on background lipid-lowering therapies or with documented statin intolerance. Participants receiving enlicitide experienced significant reductions in LDL-C at week 24—the study's primary endpoint—and sustained reductions through one year (week 52). Secondary endpoints also showed notable improvements, with reductions in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a) [Lp(a)] at week 24. The treatment was well-tolerated, with a safety profile comparable to placebo. Adherence to the study protocol was high, with 97% compliance in both intervention and dosing instructions.

At the one-year mark, enlicitide continued to deliver strong results, showing a sustained LDL-C reduction of 47.6%, and 52.4% in a post-hoc analysis, compared to placebo. At week 24, reductions in non-HDL-C reached 53.4%, ApoB dropped by 50.3%, and Lp(a) decreased by 28.2%. Impressively, 67.5% of patients treated with enlicitide achieved the stringent target of at least a 50% reduction in LDL-C and an LDL-C level below 55 mg/dL (1.42 mmol/L), compared to just 1.2% in the placebo group.

The company noted that the Safety outcomes were favorable, with no significant differences between the enlicitide and placebo groups in terms of adverse events, serious adverse events, or mortality. These findings position enlicitide as a promising new option in the management of cholesterol for patients with ASCVD or statin intolerance.

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