Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. — V-Mono  

Hypercholesterolemia Clinical Trial

Official title: A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)

Status Active, not recruiting

Clinical Trial Summary

CKJX839D12304 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo or ezetimibe can effectively reduce LDL-C as measured by percentage change from baseline to Day 150. This study is being conducted in eligible participants with primary hypercholesterolemia not receiving any lipid-lowering therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk of less than 7.5%.

Clinical Trial Description

This study is a randomized, double-blind, placebo- and active comparator-controlled, multicenter study in 300 adult participants with primary hypercholesterolemia not receiving any LLT with a 10-year ASCVD risk score of less than 7.5%. This study will evaluate the efficacy and safety of inclisiran sodium 300 mg, administered as a monotherapy in comparison to ezetimibe and placebo.

The study consists of:

• a screening period of up to 14 days;

• a double-blind treatment period of 150+/- 5 days during which participants will be randomly assigned to either the inclisiran arm, the ezetimibe arm or the placebo arm in a 2:1:1 ratio; and

• a safety follow-up / End of Study visit conducted 30+5 days after the Day 150 visit.

The overall study duration is approximately 190 days. ;

Related Conditions & MeSH terms

• Hypercholesterolemia

• NCT number: NCT05763875
• Study type: Interventional
• Source: Novartis
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 15, 2023
• Completion date: June 21, 2024