NCT05763875

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

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change from baseline to Day 150. This study was 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%.

Detailed description

This study was a randomized, double-blind, placebo- and active comparator-controlled, multicenter study in 350 adult participants with primary hypercholesterolemia not receiving any LLT with a 10-year ASCVD risk score of less than 7.5%. This study evaluated the efficacy and safety of inclisiran sodium 300 mg, administered as a monotherapy in comparison to ezetimibe and placebo. The study consisted of: * a screening period of up to 14 days; * a double-blind treatment period of 150+/- 5 days during which participants were 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 was approximately 190 days.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Inclisiran	284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
DRUG	Ezetimibe	10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
DRUG	Matching Placebo for Inclisiran	0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
DRUG	Matching Placebo for Ezetimibe	0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-06-20
• Completion: 2024-06-20
• First posted: 2023-03-10
• Last updated: 2025-10-16
• Results posted: 2025-08-13

Locations

42 sites across 5 countries: United States, Colombia, Germany, Hungary, Mexico

Regulatory

• FDA-regulated drug study