Merck stock rises on successful Phase 3 trial results for its cholesterol drug

Published 09/06/2025, 12:08
© Reuters.

Investing.com -- Shares of Merck & Co Inc (NYSE:MRK) climbed 1.6% following the announcement of positive topline results from two Phase 3 clinical trials for enlicitide decanoate, an investigational oral PCSK9 inhibitor. The trials, named CORALreef HeFH and CORALreef AddOn, met their primary and key secondary endpoints, showing significant reductions in low-density lipoprotein cholesterol (LDL-C) compared to placebo and other oral non-statin therapies.

The results highlighted enlicitide’s potential in treating adults with hyperlipidemia who are already on lipid-lowering therapies, including statins. The CORALreef HeFH trial demonstrated that enlicitide significantly reduced LDL-C levels in adults with heterozygous familial hypercholesterolemia (HeFH), a condition that increases the risk for atherosclerotic cardiovascular disease (ASCVD). Similarly, the CORALreef AddOn study showed that enlicitide outperformed ezetimibe and bempedoic acid in adults with hyperlipidemia at risk for ASCVD.

Dr. Dean Y. Li, president of Merck (NSE:PROR) Research Laboratories, expressed excitement about the clinical development program’s first Phase 3 results, noting the urgency to make this oral therapy available to patients worldwide. If approved, enlicitide would be the first oral PCSK9 inhibitor marketed in the U.S., offering a daily pill alternative to the existing injectable treatments.

The announcement also stated that there were no clinically meaningful differences in the incidence of adverse events (AE) and serious adverse events (SAE) between enlicitide and the control treatments in both trials. The complete results from the Phase 3 trials are expected to be presented at a future scientific congress.

Merck’s stock movement today reflects investor confidence in the potential market opportunity for enlicitide, given the current demand for more convenient cholesterol-lowering treatments. The positive trial outcomes could represent a significant advancement in the management of hyperlipidemia and familial hypercholesterolemia, pending regulatory approval and successful commercialization.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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