Twice-yearly Leqvio (inclisiran) demonstrated clinically meaningful, statistically significant LDL-C lowering as a monotherapy in patients at low or moderate ASCVD risk.- Novartis
Novartis announced positive topline results from twice-yearly (after an initial dose and another at three months), Leqvio (inclisiran) in the Phase III V-MONO study, which met its primary endpoints
Leqvio monotherapy achieved clinically meaningful and statistically significant low-density lipoprotein cholesterol (LDL-C) lowering versus both placebo and ezetimibe in patients who were at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) and not receiving lipid-lowering therapy.
V-MONO is the first trial evaluating a small interfering RNA (siRNA) therapy taken as monotherapy to lower LDL-C in patients at low or moderate risk of developing ASCVD. Novartis plans to present results from this trial at an upcoming medical meeting and share with regulatory agencies including the FDA.
“We are proud that we continue to advance the scientific understanding of using siRNA therapy to tackle one of the world’s biggest healthcare challenges, as too many people still struggle to reach their cholesterol goals,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “This trial adds to the growing body of evidence for Leqvio across the full spectrum of ASCVD as we strive to help more patients in need.”
Novartis continues to advance multiple studies evaluating the potential use of Leqvio across primary and secondary prevention. VICTORION-1-PREVENT (V1P) is the only dedicated study of a non-statin lipid-lowering therapy in a high-risk primary prevention population as defined by American College of Cardiology (ACC) and American Heart Association (AHA) guidelines; this outcomes study is expected to complete enrollment later this year. In the secondary prevention setting, the ORION-4 and VICTORION-2-PREVENT (V2P) outcomes studies remain on track for data readouts in 2026 and 2027, respectively.
About V-MONO: V-MONO (CKJX839D12304) is a 6-month randomized, double-blind, placebo- and active-comparator controlled Phase III study to evaluate the efficacy of Leqvio as monotherapy in patients at low or moderate risk of developing ASCVD who are not receiving lipid-lowering therapy. A total of 350 patients were randomized in a 2:1:1 ratio to inclisiran (n=174), ezetimibe (n=89) or placebo (n=87). The primary endpoints were the percent change in LDL-C from baseline to Day 150 with Leqvio versus placebo and ezetimibe.
About VictORION: The V-MONO study is part of VictORION, a clinical trial program to expand the foundational evidence of LDL-C reduction with Leqvio in diverse patient populations through randomized clinical trials, implementation research, real-world evidence, and primary and secondary prevention trials assessing the potential benefits of Leqvio on cardiovascular outcomes. The VictORION program is one the largest clinical trial programs of its kind, enrolling over 60,000 patients in more than 50 countries worldwide across more than 30 trials, including ORION-4 (secondary prevention), V-2-PREVENT (secondary prevention), V-1-PREVENT (high-risk primary prevention), V-INCEPTION and V-INCLUSION.
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