Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
V-Mono
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)
1 other identifier
interventional
350
5 countries
42
Brief Summary
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2023
Shorter than P25 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedStudy Start
First participant enrolled
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2024
CompletedResults Posted
Study results publicly available
August 13, 2025
CompletedOctober 16, 2025
October 1, 2025
1.3 years
February 28, 2023
June 17, 2025
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150
Percentage change in LDL-C from Baseline (day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Baseline, Day 150
Secondary Outcomes (8)
Absolute Change in LDL-C From Baseline to Day 150
Baseline, Day 150
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 150
Baseline, Day 150
Percentage Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Day 150
Baseline, Day 150
Percentage Change in Total Cholesterol (TC)/HDL-C Ratio From Baseline to Day 150
Baseline, Day 150
Percentage Change in Apolipoprotein B (Apo B) From Baseline to Day 150
Baseline, Day 150
- +3 more secondary outcomes
Study Arms (3)
Inclisiran
EXPERIMENTALInclisiran s.c and Placebo p.o
Ezetimibe
ACTIVE COMPARATORPlacebo s.c. and Ezetimibe p.o.
Placebo
PLACEBO COMPARATORPlacebo s.c. and Placebo p.o.
Interventions
284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Eligibility Criteria
You may qualify if:
- informed consent signed prior to participation in study
- fasting LDL-C of \>= 100 mg/dL but \< 190 mg/dL
- fasting triglycerides \<= 400 mg/dL
- year ASCVD risk score \< 7.5%
- not on any lipid-lowering therapy within 90 days of screening
You may not qualify if:
- history of ASCVD
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
SEC Clinical Research
Dothan, Alabama, 36305, United States
Hillcrest Medical Research
DeLand, Florida, 32720, United States
ClinCloud
Maitland, Florida, 32751, United States
Alma Clinical Research Inc
Miami, Florida, 33165, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
Harmony Clinical Research
North Miami Beach, Florida, 33162, United States
Fam Medical Specialists Of Fl Plc
Plant City, Florida, 33563, United States
Cozy Research LLC
Zephyrhills, Florida, 33541, United States
Koch Family Medicine
Morton, Illinois, 61550, United States
Grace Research LLC
Bossier City, Louisiana, 71111, United States
Grace Research Llc
Shreveport, Louisiana, 71101, United States
Southern Clin Research Clinic
Zachary, Louisiana, 70791, United States
Prime Global Research Inc
The Bronx, New York, 10456, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Lillestol Research LLC
Fargo, North Dakota, 58103, United States
WellNow Urgent Care and Research
Huber Heights, Ohio, 45424, United States
Conrad Clinical Research
Edmond, Oklahoma, 73013, United States
Compass Point Research
Nashville, Tennessee, 37203, United States
Mt Olympus Medical Research
Sugar Land, Texas, 77479, United States
Dominion Medical Associates
Richmond, Virginia, 23219, United States
Spaulding Clinical Research
West Bend, Wisconsin, 53095, United States
Novartis Investigative Site
Barranquilla, Atlántico, 080012, Colombia
Novartis Investigative Site
Floridablanca, Santander Department, 57-7, Colombia
Novartis Investigative Site
Manizales, 170008, Colombia
Novartis Investigative Site
San Gil, 684031, Colombia
Novartis Investigative Site
Munich, Bavaria, 80809, Germany
Novartis Investigative Site
Hanover, Lower Saxony, 30449, Germany
Novartis Investigative Site
Löhne, North Rhine-Westphalia, 32584, Germany
Novartis Investigative Site
Jerichow, Saxony-Anhalt, 39319, Germany
Novartis Investigative Site
Berlin, 10787, Germany
Novartis Investigative Site
Bochum, 44789, Germany
Novartis Investigative Site
Gladbeck, 45968, Germany
Novartis Investigative Site
Hamburg, 22607, Germany
Novartis Investigative Site
Papenburg, 26871, Germany
Novartis Investigative Site
Budapest, 1083, Hungary
Novartis Investigative Site
Pécs, 7623, Hungary
Novartis Investigative Site
Monterrey, Nuevo León, 64060, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, 64440, Mexico
Novartis Investigative Site
Mérida, Yucatán, 97070, Mexico
Novartis Investigative Site
Culiacan Sinaloa, 80230, Mexico
Novartis Investigative Site
Querétaro, 76000, Mexico
Related Publications (1)
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.
PMID: 40392667DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Sponsor Personnel participating in the study conduct were also be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2023
First Posted
March 10, 2023
Study Start
March 15, 2023
Primary Completion
June 20, 2024
Study Completion
June 20, 2024
Last Updated
October 16, 2025
Results First Posted
August 13, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com