Merck & Co. Inc. (NYSE: MRK), recognized as MSD in markets outside the United States and Canada, has announced its participation in the upcoming American Heart Association (AHA) Scientific Sessions 2025, scheduled to take place from November 7 to 10 in New Orleans, Louisiana. The company will present new data from its innovative cardio-pulmonary pipeline and portfolio, underscoring its commitment to addressing the global burden of cardio-pulmonary diseases such as hypercholesterolemia and pulmonary arterial hypertension (PAH).

2. Highlights of the Presentation

Merck's presentation will include the first detailed findings from two pivotal Phase 3 trials of enlicitide, an investigational oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. This drug aims to provide a groundbreaking approach to managing high cholesterol levels in individuals at risk for cardiovascular events.

Key Trials to be Discussed

CORALreef Lipids Trial: This pivotal Phase 3 trial represents the largest study of enlicitide to date, focusing on its safety and efficacy in adults with hypercholesterolemia and a history of major atherosclerotic cardiovascular disease (ASCVD) events or those at increased risk.

CORALreef HeFH Trial: This trial investigates the safety and efficacy of enlicitide in adults with heterozygous familial hypercholesterolemia (HeFH) who are at risk for major ASCVD events.

PULSAR, STELLAR, and ZENITH Trials: A pooled analysis will evaluate mortality and major morbidity outcomes in adults with PAH treated with WINREVAIR™ (sotatercept-csrk), providing crucial insights into this life-threatening condition.

3. Insights from Merck Leadership

Dr. Joerg Koglin, Senior Vice President and Head of General and Specialty Medicine at Merck Research Laboratories, emphasized the significance of the upcoming AHA sessions. He stated, “For the first time, clinicians will see results from two pivotal trials from the Phase 3 clinical program for enlicitide. If approved, this oral PCSK9 inhibitor could significantly address the burden of hypercholesterolemia.”

Dr. Koglin highlighted the ongoing cardiovascular disease epidemic, stating that it continues to be the leading cause of death worldwide, with atherosclerotic cardiovascular disease accounting for the majority of these fatalities. He reaffirmed Merck's commitment to advancing research in this critical area.

4. Investor Event Announcement

In conjunction with the AHA Scientific Sessions, Merck will host an Investor Event on Sunday, November 9, 2025, at 6:00 p.m. CT. The event will provide an update on Merck's cardio-pulmonary strategy and program, accessible via webcast. Investors, analysts, media representatives, and the general public can participate through a dedicated web link and dial-in options.

5. Abstracts to be Presented

Merck will present various abstracts at the AHA Scientific Sessions, including:

Hypercholesterolemia

Efficacy and Safety of Enlicitide: Details from the Phase 3 CORALreef Lipids trial (Abstract #4391578) will be presented in an oral session on Saturday, November 8, at 2:30 p.m. ET.

Enlicitide in HeFH: Findings from a Phase 3 trial on enlicitide's effectiveness in patients with heterozygous familial hypercholesterolemia (Abstract #4391641) will be shared in a moderated digital poster session on Sunday, November 9, at 5:00 p.m. ET.

Pulmonary Arterial Hypertension

Sotatercept and PAH Outcomes: An analysis of the impact of sotatercept on mortality and morbidity outcomes in PAH patients (Abstract #4387511) will be presented in an oral session on Saturday, November 8, at 11:30 a.m. ET.

6. Focus on Cardio-Pulmonary Health

Merck has been at the forefront of cardiovascular disease research for decades, with a history of developing therapies that address significant health challenges. Cardiovascular disease remains one of the leading causes of death globally, claiming approximately 18 million lives each year. Merck's commitment to advancing research in this area is crucial for improving patient outcomes and addressing the silent epidemic of heart disease.

7. Conclusion

As Merck prepares for its presentation at the AHA Scientific Sessions 2025, the company’s innovative approaches to treating hypercholesterolemia and PAH stand to make a significant impact on cardiovascular health. The upcoming trials and investor event are anticipated to shed light on the future of cardio-pulmonary therapies and reinforce Merck's position as a leader in the biopharmaceutical sector.

Original press release