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Merck & Co., Inc. has announced that its innovative oral PCSK9 inhibitor, Enlicitide (MK-0616), has successfully met the primary endpoints in two pivotal Phase III clinical trials for the treatment of hypercholesterolemia. This milestone marks Enlicitide as the world's first oral PCSK9 inhibitor to triumph in Phase III trials. The CORALreef HeFH and CORALreef AddOn studies rigorously compared the efficacy and safety of Enlicitide against placebo and other lipid-lowering therapies. The findings revealed that Enlicitide significantly decreased LDL-C levels in patients and exhibited an excellent safety profile. Upon approval, Enlicitide is poised to become the first oral PCSK9 inhibitor available on the U.S. market, offering a groundbreaking treatment alternative for individuals with hypercholesterolemia.
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