Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. - Trial NCT05763875
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.
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Study Focus
Sponsor & Location
Novartis Pharmaceuticals
Novartis
Timeline & Enrollment
Phase 3
Mar 15, 2023
Oct 30, 2024
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
Data Source
ClinicalTrials.gov
NCT05763875
Non-Device Trial