Merck & Co. Inc. (NYSE:MRK) on Tuesday shared topline results from the Phase 3 CORALreef Lipids trial evaluating the safety and efficacy of enlicitide decanoate for hypercholesterolemia on a moderate or high intensity statin (or with documented statin intolerance).

Hypercholesterolemia, a type of hyperlipidemia, is a disorder in which there are elevated LDL cholesterol levels in the blood. It affects approximately 86 million adults in the U.S. and is a major risk driver for ASCVD, accounting for 85% of cardiovascular deaths.

Enlicitide is an investigational, potentially first oral PCSK9 inhibitor designed to lower LDL-C via the same biological mechanism as currently approved monoclonal antibody, injectable PCSK9 inhibitors but in a daily pill form.

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The trial met all primary and key secondary endpoints. Treatment with enlicitide resulted in statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) compared to placebo at Week 24.

Statistically and clinically significant reductions were also seen for enlicitide versus placebo across all key secondary endpoints, including in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a) [Lp(a)].

There were no clinically meaningful differences in proportions of participants with adverse events (AE), including serious adverse events (SAE), between treatment groups. Discontinuations due to adverse events were low and comparable between treatment groups.

On Saturday, Merck released data from the Phase 3 VICTOR trial comparing VERQUVO to placebo in patients with stable chronic heart failure and reduced ejection fraction (HFrEF) without a recent worsening heart failure event treated with guideline-directed medical therapy (GDMT).

Results showed that VERQUVO did not significantly reduce the risk of the primary composite outcome of time to cardiovascular death or hospitalization for heart failure, which occurred in 18% of patients treated with VERQUVO compared to 19.1% in the placebo group.

For the key secondary endpoints, cardiovascular death was numerically lower with VERQUVO (9.6%) compared to placebo (11.3%), and heart failure hospitalization occurred in 11.4% of patients receiving VERQUVO and 11.9% of patients receiving placebo.

In a separate pre-specified pooled analysis of patient-level data from the complementary Phase 3 VICTOR and VICTORIA trials, VERQUVO reduced the risk of the composite primary endpoint of cardiovascular death or heart failure hospitalization across these patients with a broad range of disease severity.

Price Action: MRK stock is trading higher by 1.34% to $85.25 at last check Tuesday.

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