At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Inclisiran, Ezetimibe, and 2 other interventions for Hypercholesterolemia. Completed, enrolled 350 participants across 42 sites in 5 countries.
Detailed 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%.
Study Details
Timeline
Interventions
284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149