Novartis Reports Positive Phase 4 Trial Results for Hypercholesterolemia Drug

Novartis AG has reported positive results from a Phase 4 trial of its hypercholesterolemia drug. The trial demonstrated significant reductions in LDL cholesterol levels, with patients receiving the drug experiencing a 40% reduction in LDL cholesterol compared to a 15% reduction in the placebo group. The results suggest the drug's potential to improve cardiovascular health.

Novartis AG has announced significant results from a Phase IV trial of its hypercholesterolemia drug, Leqvio. The trial, known as V-DIFFERENCE, evaluated the efficacy and safety of Leqvio in comparison to a placebo, both administered alongside individually optimized lipid-lowering therapy (LLT) [1]. The study demonstrated that patients receiving Leqvio experienced a 40% reduction in LDL cholesterol levels, compared to a 15% reduction in the placebo group [1].

The V-DIFFERENCE study, which enrolled over 60,000 patients from 50 countries, is the largest LDL-C lowering study with Leqvio to date. It is also the first study to focus on patient-centered outcomes, including muscle pain and quality-of-life scores [1]. The results showed that 85% of patients on Leqvio plus LLT achieved their guideline-recommended LDL-C targets within 90 days, compared to 31% in the placebo group [1]. Moreover, patients on Leqvio were 43% less likely to experience muscle-related adverse events compared to those on placebo [1].

The study's findings are particularly notable for their potential to improve cardiovascular health. The ability of Leqvio to significantly reduce LDL cholesterol levels and minimize muscle pain associated with traditional cholesterol-lowering therapies could lead to better patient outcomes and adherence to treatment [1]. This is particularly relevant given that a majority of patients with high cholesterol continue to remain above recommended LDL-C levels [1].

Novartis has positioned Leqvio as a transformative therapy in the cardiovascular space, leveraging its unique siRNA technology. The drug is administered subcutaneously by a healthcare provider, with an initial dose followed by doses every six months. This approach may help circumvent the challenges of treatment adherence, which is a common issue in cholesterol management [1].

The positive results from the V-DIFFERENCE study further underscore Novartis's commitment to addressing unmet medical needs and driving innovation in cardiovascular care. The company's strategic partnerships and affordability programs aim to accelerate market access and enhance patient adoption of its therapies [1].

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