Merck's Cholesterol Drug Achieves Primary Endpoint in Phase III Trial

Merck's cholesterol drug has met its main goal in a late-stage trial, according to the company. The drug aims to reduce the risk of cardiovascular events in patients with high cholesterol. Merck's net sales are primarily driven by pharmaceutical products, vaccines, and animal health products, with the US, Europe, China, and Japan being key markets.

Merck & Co., Inc. (NYSE: MRK), known as MSD outside of the United States and Canada, has reported significant results from a late-stage trial of its cholesterol-lowering drug, WINREVAIR™ (sotatercept-csrk). The trial, known as V-DIFFERENCE, demonstrated that the drug effectively reduced LDL cholesterol levels, meeting its main goal of improving cardiovascular health. Merck's announcement comes as the company continues to focus on addressing unmet medical needs and driving innovation in cardiovascular care.

The V-DIFFERENCE study, which enrolled over 60,000 patients from 50 countries, evaluated the efficacy and safety of WINREVAIR™ in comparison to a placebo, both administered alongside individually optimized lipid-lowering therapy (LLT). The study demonstrated that patients receiving WINREVAIR™ experienced a 40% reduction in LDL cholesterol levels, compared to a 15% reduction in the placebo group [1]. Furthermore, 85% of patients on WINREVAIR™ plus LLT achieved their guideline-recommended LDL-C targets within 90 days, compared to 31% in the placebo group. Patients on WINREVAIR™ were also 43% less likely to experience muscle-related adverse events compared to those on placebo.

The results from the V-DIFFERENCE study underscore Merck's commitment to advancing cardiovascular research and improving patient outcomes. The drug's unique mechanism of action, which involves siRNA technology, may help circumvent the challenges of treatment adherence, a common issue in cholesterol management.

Merck's focus on cardiovascular disease is part of its broader strategy to address global health challenges. The company's net sales are primarily driven by pharmaceutical products, vaccines, and animal health products, with the US, Europe, China, and Japan being key markets. Merck's ongoing commitment to innovation and research in cardiovascular care is evident in its recent presentations at the European Society of Cardiology Congress (ESC) 2025, where it shared new clinical trial and outcomes research data [2].

References:
[1] Novartis Leqvio® shows statistically significant and clinically meaningful early LDL-C goal achievement with less muscle pain. Available at: https://www.globenewswire.com/news-release/2025/08/30/3141878/0/en/Novartis-Leqvio-shows-statistically-significant-and-clinically-meaningful-early-LDL-C-goal-achievement-with-less-muscle-pain.html
[2] Merck Demonstrates Ongoing Commitment to Advancing Cardiovascular Disease Management and Patient Care with New Data at the European Society of Cardiology Congress 2025. Available at: https://www.businesswire.com/news/home/20250825451374/en/Merck-Demonstrates-Ongoing-Commitment-to-Advancing-Cardiovascular-Disease-Management-and-Patient-Care-with-New-Data-at-the-European-Society-of-Cardiology-Congress-2025