Novartis pelacarsen misses primary endpoint in Phase III Lp(a)HORIZON cardiovascular trial

Novartis has reported that the Phase III Lp(a)HORIZON study of pelacarsen did not achieve its primary endpoint in patients with elevated lipoprotein(a), known as Lp(a), and established cardiovascular disease.

The cardiovascular outcomes trial assessed whether pelacarsen could lower the risk of major cardiovascular events compared with placebo. The primary endpoint combined cardiovascular death, non fatal myocardial infarction, non fatal stroke and urgent coronary revascularization requiring hospitalisation.

Although treatment with pelacarsen reduced Lp(a) levels in the study population, this did not result in a statistically demonstrated reduction in cardiovascular risk across the overall trial population. Participants were also receiving guideline directed care, including treatments to lower lipids and manage high blood pressure.

The findings add further evidence to the understanding of whether reducing Lp(a) can translate into improved cardiovascular outcomes. Elevated Lp(a) is an inherited cardiovascular risk factor estimated to affect around one in five people worldwide, and there is currently no approved treatment specifically targeting it.

Shreeram Aradhye, president of Development and chief medical officer at Novartis, said Lp(a)HORIZON was designed to investigate whether lowering Lp(a) could reduce residual cardiovascular risk in patients whose other major cardiovascular risk factors were already being managed with optimised guideline directed treatment.

He said that while pelacarsen successfully lowered Lp(a), the study did not show that this reduction led to a lower risk of cardiovascular events in the overall population. Aradhye added that although the outcome was not what Novartis had hoped for, the results provide useful evidence about the relationship between Lp(a) reduction and cardiovascular outcomes and could help guide future approaches to cardiovascular risk management.

He also thanked the more than 8,000 participants and investigators involved in the trial and said the company remains committed to cardiovascular research and innovation.

Novartis plans to present the full Lp(a)HORIZON findings at an upcoming medical congres

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cardiology, cardiovascular, Cardiovascular Disease, clinical trials, LpA, Novartis, pharma news, Phase 3