Status and phase
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About
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%.
Full 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:
The overall study duration is approximately 190 days.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria to be met at screening:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
350 participants in 3 patient groups, including a placebo group
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Central trial contact
Novartis Pharmaceuticals; Novartis Pharmaceuticals
Data sourced from clinicaltrials.gov
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