NCT05192941

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

Efficacy, Safety, Tolerability and Quality of Life of Ongoing Individually Optimized Lipid-lowering Therapy With or Without Inclisiran (KJX839) - a Randomized, Placebo-controlled, Double-blind Multicenter Phase IV Study in Participants With Hypercholesterolemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,770 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed description

This was a double-blind, placebo-controlled multicenter study in adult participants with very high or high cardiovascular risk who did not meet their individual LDL-C target despite being treated with their individual maximum tolerated dose (MTD) of a statin, and if applicable, further Lipid-Lowering Therapy (LLT). The purpose of this study was to demonstrate the superiority of inclisiran compared to placebo, both on top of ongoing individually optimized LLT, on reaching a participant's LDL-C target (\< 55 mg/dL or \< 70 mg/dL, depending on the cardiovascular risk category), according to the 2019 ESC/EAS guidelines for the management of dyslipidemias as well as on patient-relevant safety, tolerability outcomes and quality of life.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Inclisiran Sodium	Subcutaneously injected on Day 1, Day 90, and Day 270
DRUG	Placebo	Placebo to inclisiran 300 mg subcutaneously

Timeline

• Start date: 2022-04-08
• Primary completion: 2024-06-11
• Completion: 2025-03-19
• First posted: 2022-01-14
• Last updated: 2026-04-14
• Results posted: 2026-04-14

Locations

136 sites across 8 countries: Bulgaria, Czechia, Estonia, France, Germany, Latvia, Poland, Spain