Merck’s enlicitide decanoate meets primary and secondary Phase 3 endpoints

Merck (MRK) announced positive topline results from the Phase 3 CORALreef Lipids trial evaluating the safety and efficacy of enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9, or PCSK9, inhibitor being evaluated for the treatment of adults with hypercholesterolemia on a moderate or high intensity statin. The CORALreef Lipids trial successfully met all primary and key secondary endpoints. Treatment with enlicitide resulted in statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol, or LDL-C, vs. 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 and lipoprotein(a). There were no clinically meaningful differences in proportions of participants with adverse events, including serious adverse events, between treatment groups. Discontinuations due to adverse events were low and comparable between treatment groups. Merck plans to share these results with regulatory authorities worldwide and will present the data at a future scientific congress.