Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
NCT ID: NCT05763875
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
2023-03-15
2024-06-20
Brief Summary
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Detailed Description
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The study consisted of:
* a screening period of up to 14 days;
* a double-blind treatment period of 150+/- 5 days during which participants were randomly assigned to either the inclisiran arm, the ezetimibe arm or the placebo arm in a 2:1:1 ratio; and
* a safety follow-up / End of Study visit conducted 30+5 days after the Day 150 visit.
The overall study duration was approximately 190 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Inclisiran
Inclisiran s.c and Placebo p.o
Inclisiran
284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
Matching Placebo for Ezetimibe
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Ezetimibe
Placebo s.c. and Ezetimibe p.o.
Ezetimibe
10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
Matching Placebo for Inclisiran
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
Placebo
Placebo s.c. and Placebo p.o.
Matching Placebo for Inclisiran
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
Matching Placebo for Ezetimibe
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Interventions
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Inclisiran
284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
Ezetimibe
10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
Matching Placebo for Inclisiran
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
Matching Placebo for Ezetimibe
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* fasting LDL-C of \>= 100 mg/dL but \< 190 mg/dL
* fasting triglycerides \<= 400 mg/dL
* 10-year ASCVD risk score \< 7.5%
* not on any lipid-lowering therapy within 90 days of screening
Exclusion Criteria
* diabetes mellitus or fasting plasma glucose of \>= 7.0 mmol/L or HbA1c \>= 6.5%
* secondary hypercholesterolemia, e.g. hypothyroidism (TSH above upper limit of normal)
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Floridablanca, Santander Department, Colombia
Novartis Investigative Site
Manizales, , Colombia
Novartis Investigative Site
San Gil, , Colombia
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Hanover, Lower Saxony, Germany
Novartis Investigative Site
Löhne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Jerichow, Saxony-Anhalt, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Gladbeck, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Papenburg, , Germany
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Pécs, , Hungary
Novartis Investigative Site
Monterrey, Nuevo León, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, Mexico
Novartis Investigative Site
Mérida, Yucatán, Mexico
Novartis Investigative Site
Culiacan Sinaloa, , Mexico
Novartis Investigative Site
Querétaro, , Mexico
Countries
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References
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Taub PR, Gutierrez A, Wewers D, Garcia Cantu E, Cao H, Deck C, Lesogor A, Ott D, Mena-Madrazo J, Zang X, Wright RS. Safety and Lipid-Lowering Efficacy of Inclisiran Monotherapy in Patients Without ASCVD: The VICTORION-Mono Randomized Clinical Trial. J Am Coll Cardiol. 2025 Jul 22;86(3):196-208. doi: 10.1016/j.jacc.2025.04.049. Epub 2025 May 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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CKJX839D12304
Identifier Type: -
Identifier Source: org_study_id
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