Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Completed · Phase 3 · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
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%.
Key facts
- Study ID
- NCT05763875
- Run by
- Novartis Pharmaceuticals
- People needed
- 350
- Starts
- 2023-03-15
- Expected to finish
- 2024-06-20
- Last updated by the study team
- 2025-10-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Pécs, Hungary
- Novartis Investigative Site — Papenburg, Germany
- Novartis Investigative Site — Budapest, Hungary
- Parkway Medical Center — Birmingham, Alabama, United States
- SEC Clinical Research — Dothan, Alabama, United States
- Hillcrest Medical Research — DeLand, Florida, United States
- ClinCloud — Maitland, Florida, United States
- Alma Clinical Research Inc — Miami, Florida, United States
- Inpatient Research Clinical LLC — Miami Lakes, Florida, United States
- Harmony Clinical Research — North Miami Beach, Florida, United States
- Fam Medical Specialists Of Fl Plc — Plant City, Florida, United States
- Cozy Research LLC — Zephyrhills, Florida, United States
- Koch Family Medicine — Morton, Illinois, United States
- Grace Research LLC — Bossier City, Louisiana, United States
- Grace Research Llc — Shreveport, Louisiana, United States
- Southern Clin Research Clinic — Zachary, Louisiana, United States
- Prime Global Research Inc — The Bronx, New York, United States
- Monroe Biomedical Research — Monroe, North Carolina, United States
- Lillestol Research LLC — Fargo, North Dakota, United States
- WellNow Urgent Care and Research — Huber Heights, Ohio, United States
- Conrad Clinical Research — Edmond, Oklahoma, United States
- Compass Point Research — Nashville, Tennessee, United States
- Mt Olympus Medical Research — Sugar Land, Texas, United States
- Dominion Medical Associates — Richmond, Virginia, United States
- Spaulding Clinical Research — West Bend, Wisconsin, United States
Full record on ClinicalTrials.gov
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