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Merck Announces Positive Topline Results From the First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia
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June 9, 2025 6:45 am ET
Enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C in both Phase 3 CORALreef HeFH and CORALreef AddOn trials
Enlicitide, a novel macrocyclic peptide, has the potential to be the first approved oral PCSK9 inhibitor
RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia on lipid-lowering therapies, including at least a statin. The CORALreef HeFH and CORALreef AddOn trials successfully met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) for enlicitide compared to placebo (CORALreef HeFH) and compared to other oral non-statin therapies (CORALreef AddOn). There were no clinically meaningful differences in incidences of adverse events (AE) and serious adverse events (SAE) in either trial.
Results from the three Phase 3 trials in the CORALreef clinical development program will be presented at a future scientific congress.
https://www.merck.com/news/merck-announces-positive-topline-results-from-the-first-two-phase-3-coralreef-trials-evaluating-enlicitide-decanoate-for-the-treatment-of-adults-with-hyperlipidemia/
Efficacy and Safety of the Oral PSK9 Inhibitor, MK-0616, a Macrocyclic Peptide, in the Treatment of Hypercholesterolemia: A Phase 2b Randomized Placebo-Controlled Clinical
Trial- slides
https://www.natap.org/2023/HIV/ACC-2023_Ballantyne_MK-0616_Hypercholesterolemia_OralPresentation.pdf
Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616
https://www.jacc.org/doi/10.1016/j.jacc.2023.02.018
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