Merck (NYSE: MRK), also known as MSD outside the United States and Canada, has announced its intention to unveil fresh research from its cardio-pulmonary pipeline at the American Heart Association (AHA) Scientific Sessions 2025. This event will take place from November 7 to 10 in New Orleans, Louisiana.
The data presented will underscore Merck”s commitment to tackling the challenges posed by cardio-pulmonary diseases, particularly focusing on hypercholesterolemia and pulmonary arterial hypertension (PAH). Among the key findings being shared are:
- The inaugural presentation of detailed results from the pivotal Phase 3 CORALreef Lipids trial, which is the most extensive study of enlicitide decanoate to date. This trial assesses the safety and efficacy of enlicitide, an investigational oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, for adults with hypercholesterolemia and a history of major atherosclerotic cardiovascular disease (ASCVD) events or those at heightened risk.
- The first detailed results from the Phase 3 CORALreef HeFH trial, which evaluates the safety and efficacy of enlicitide in adults diagnosed with heterozygous familial hypercholesterolemia (HeFH) who are at risk for significant ASCVD events.
- A pooled analysis from the PULSAR, STELLAR, and ZENITH trials that examines mortality and major morbidity outcomes in adults with PAH treated with WINREVAIR™ (sotatercept-csrk).
Dr. Joerg Koglin, senior vice president and head of general and specialty medicine at Merck Research Laboratories, stated, “The AHA will mark a significant moment, as clinicians will for the first time see results from two pivotal trials in the Phase 3 clinical program for enlicitide. If approved, this oral PCSK9 inhibitor could significantly alleviate the burden of hypercholesterolemia.” He added that cardiovascular disease remains the leading cause of death globally, with atherosclerotic cardiovascular disease accounting for a substantial portion of these fatalities.
In conjunction with the AHA Scientific Sessions, Merck will host an Investor Event on Sunday, November 9, 2025, at 6:00 PM CT. Senior management will provide insights into the company”s cardio-pulmonary strategy and ongoing programs. This event will be available via webcast, allowing investors, analysts, media members, and the public to participate.
Details regarding Merck”s abstracts at the AHA Scientific Sessions include:
- Abstract #4391578: Efficacy and safety of enlicitide for lowering LDL cholesterol in adults at-risk for ASCVD.
- Abstract #4391641: A Phase 3 trial of enlicitide in individuals with heterozygous familial hypercholesterolemia.
- Abstract #4359798: The correlation between significant LDL cholesterol reduction and improved long-term outcomes post-myocardial infarction.
- Abstract #4341629: The impact of insufficient lipid-lowering therapy on cardiovascular events and healthcare utilization in U.S. adults.
- Abstract #4387511: The effect of sotatercept on mortality and morbidity in PAH patients.
Enlicitide is poised to potentially be the first FDA-approved oral PCSK9 inhibitor, designed to lower LDL cholesterol levels similarly to existing injectable monoclonal antibody therapies, but in a convenient daily pill. It functions as a small molecule macrocyclic peptide that binds to PCSK9, inhibiting its interaction with LDL receptors, which play a critical role in cholesterol regulation.
Hypercholesterolemia is a significant health concern affecting millions in the U.S. and is a major contributor to ASCVD. In fact, nearly 70% of patients undergoing treatment for ASCVD fail to achieve target LDL cholesterol levels, which can lead to severe cardiovascular events, including heart attacks and strokes.
Atherosclerotic cardiovascular disease represents a leading cause of mortality worldwide, with prevention and management being crucial to reduce the associated health risks. Merck has a longstanding history of developing cardiovascular therapies and remains focused on addressing this global health crisis.
For more information on ongoing cardiovascular studies, visit Merck Clinical Trials.
About Merck: For over 130 years, Merck has dedicated itself to developing medicines and vaccines that significantly improve lives worldwide. The company aims to lead in research and innovation in biopharmaceuticals, striving to deliver groundbreaking health solutions.
This press release contains forward-looking statements regarding Merck, which involve risks and uncertainties that could cause actual results to differ materially from expected outcomes.
