Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

NCT05192941 ↗

Phase 4 Completed 1770 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia

Timeline

Start: 2022-04-08
Primary completion: 2024-06-11
Completion: 2025-03-19

Outcome

Met primary endpoint

registry analysis (superiority test); Inclisiran vs Placebo; p <0.0001; Odds Ratio (OR) 12.09 (95% CI 9.59 to 15.24); NCT05192941 ↗

release “V-DIFFERENCE is first study to show that Leqvio prioritized after statins helps more patients achieve guideline low-density lipoprotein cholesterol (LDL-C) goals early” novartis.com ↗

release “85% of patients on Leqvio plus individually optimized lipid-lowering therapy (LLT) achieved LDL-C targets within 90 days vs. 31% of patients on placebo plus LLT” novartis.com ↗

Publications

Landmesser U, Laufs U, Schatz U, Winzer EB, Nowak B, Kassner U, Gouni-Berthold I, Esteban A, Lubyayi L, Krueger A, Streich JH, Hentschke C, Achouba A, Banach M. Design and rationale of the VICTORION-Difference study: A phase 4 randomized, double-blind, placebo-controlled clinical trial to assess inclisiran's early efficacy, safety, tolerability, as well as its impact on quality of life in individuals with hypercholesterolemia. Am Heart J. 2025 Nov;289:117-126. doi: 10.1016/j.ahj.2025.05.014. Epub 2025 May 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inclisiran	Small interfering RNA (siRNA)	300 mg	Subcutaneous