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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)
Novartis Pharmaceuticals·Phase 3·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hypercholesterolemia
Drug/Device/Intervention
Inclisiran
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Novartis Pharmaceuticals
Funder
Novartis
Location
Birmingham,North Miami Beach,Atlanta,Bossier City,Shreveport,Monroe,Nashville,Sugar Land,Richmond, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Mar 15, 2023
End date
Oct 30, 2024
Enrollment
300 participants
Primary outcome

Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150 compared with placebo,Percentage change in LDL-C from Baseline to Day 150 compared with ezetimibe

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%.

ICD-10 classifications
Pure hypercholesterolaemiaLipoprotein deficiencyHyperglycaemia, unspecifiedDisorders of lipoprotein metabolism and other lipidaemiasOther disorders of lipoprotein metabolism
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05763875
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05763875 through Pure Global AI's free database. This Phase 3 trial is sponsored by Novartis Pharmaceuticals and is currently Recruiting. The study focuses on Hypercholesterolemia. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.