Novartis Announces Positive Topline Results from V-MONO Phase III Trial of Leqvio (Inclisiran) Demonstrating Superior LDL-C Reduction Versus Placebo and Ezetimibe
Novartis
Drug Development and Manufacturing
V-MONO III Phase Clinical Study Meets Primary Endpoint, Demonstrating Inclisiran Monotherapy Superior to Placebo and Ezetimibe in Lowering Low-Density Lipoprotein Cholesterol (LDL-C)1.
The results of this clinical study provide growing evidence of the sustained effect of inclisiran in patients with atherosclerotic cardiovascular disease (ASCVD).
The data will be shared with regulatory authorities and presented at an upcoming medical conference.
V-MONO is part of the VictORION clinical trial program, which involves 60,000 patients. This series of studies will evaluate inclisiran for the prevention of primary and secondary ASCVD in patients.
Novartis recently announced that its twice-yearly lipid-lowering product, Inclisiran, achieved positive topline results in the V-MONO Phase III clinical study, meeting its primary endpoint. Compared with placebo and ezetimibe, monotherapy with Inclisiran in patients at low or moderate risk of ASCVD who were not receiving lipid-lowering treatment demonstrated clinically meaningful and statistically significant reductions in LDL-C1.
V-MONO is the first trial to evaluate small interfering RNA (siRNA) therapy as a single drug treatment to reduce LDL-C levels in patients at low or moderate risk of ASCVD. Novartis plans to present the results of the trial at an upcoming medical conference and share them with regulatory agencies, including the U.S. Food and Drug Administration (FDA).
Novartis is continuing to advance multiple studies evaluating the potential use of inclisiran in primary and secondary prevention. VICTORION-1-PREVENT (V1P) is the only study of a non-statin lipid-lowering therapy in a high-risk primary prevention population as defined by the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines; enrollment for this outcomes study is expected to complete later this year. For secondary prevention, the ORION-4 and VICTORION-2-PREVENT (V2P) outcomes studies are still anticipated to deliver updated data in 2026 and 2027, respectively.
*Usage: Administer a booster injection three months after the initial treatment, followed by twice-yearly injections of Inclisiran Sodium Injection thereafter. See package insert for details.
Editor: Muyan
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