Merck & Co. Inc., also known as MSD outside the United States and Canada, announced positive topline results from the first two of three Phase 3 clinical trials evaluating enlicitide decanoate, an investigational oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. The trials, named CORALreef HeFH and CORALreef AddOn, assessed the safety and efficacy of enlicitide in adults with hyperlipidemia undergoing lipid-lowering therapies, including statins. Both trials met primary and key secondary endpoints, demonstrating significant reductions in low-density lipoprotein cholesterol (LDL-C) compared to placebo and other oral non-statin therapies. No significant differences in adverse event incidences were observed. Detailed results from these trials will be presented at an upcoming scientific congress. If approved, enlicitide could become the first marketed oral PCSK9 inhibitor in the U.S.
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