- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05763875
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- a screening period of up to 14 days;
- a double-blind treatment period of 150+/- 5 days during which participants will be 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 is approximately 190 days.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Novartis Pharmaceuticals
- Phone Number: 1-888-669-6682
- Email: novartis.email@novartis.com
Study Contact Backup
- Name: Novartis Pharmaceuticals
- Phone Number: +41613241111
Study Locations
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Manizales, Colombia, 170008
- Active, not recruiting
- Novartis Investigative Site
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San Gil, Colombia, 684031
- Active, not recruiting
- Novartis Investigative Site
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Atlantico
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Barranquilla, Atlantico, Colombia, 080012
- Active, not recruiting
- Novartis Investigative Site
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Santander
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Floridablanca, Santander, Colombia, 57-7
- Active, not recruiting
- Novartis Investigative Site
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Berlin, Germany, 10787
- Active, not recruiting
- Novartis Investigative Site
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Berlin, Germany, 13347
- Withdrawn
- Novartis Investigative Site
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Bochum, Germany, 44789
- Active, not recruiting
- Novartis Investigative Site
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Gladbeck, Germany, 45968
- Active, not recruiting
- Novartis Investigative Site
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Hamburg, Germany, 22607
- Active, not recruiting
- Novartis Investigative Site
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Jerichow, Germany, 39319
- Active, not recruiting
- Novartis Investigative Site
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Loehne, Germany, 32584
- Active, not recruiting
- Novartis Investigative Site
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Papenburg, Germany, 26871
- Active, not recruiting
- Novartis Investigative Site
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Bavaria
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Muenchen, Bavaria, Germany, 80809
- Active, not recruiting
- Novartis Investigative Site
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Niedersachsen
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Hannover, Niedersachsen, Germany, 30449
- Active, not recruiting
- Novartis Investigative Site
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Balatonfured, Hungary, 8230
- Withdrawn
- Novartis Investigative Site
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Budapest, Hungary, 1083
- Active, not recruiting
- Novartis Investigative Site
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Nyiregyhaza, Hungary, 4400
- Withdrawn
- Novartis Investigative Site
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Pecs, Hungary, 7623
- Active, not recruiting
- Novartis Investigative Site
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Culiacan Sinaloa, Mexico, 80230
- Active, not recruiting
- Novartis Investigative Site
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Queretaro, Mexico, 76000
- Active, not recruiting
- Novartis Investigative Site
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico, 64060
- Active, not recruiting
- Novartis Investigative Site
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Monterrey, Nuevo Leon, Mexico, 64440
- Active, not recruiting
- Novartis Investigative Site
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Yucatan
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Merida, Yucatan, Mexico, 97070
- Active, not recruiting
- Novartis Investigative Site
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Alabama
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Birmingham, Alabama, United States, 35215
- Active, not recruiting
- Parkway Medical Center
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Dothan, Alabama, United States, 36305
- Active, not recruiting
- SEC Clinical Research
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California
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Vista, California, United States, 92081
- Withdrawn
- Blue Coast Research Center LLC .
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Florida
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DeLand, Florida, United States, 32720
- Active, not recruiting
- Hillcrest Medical Research
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Maitland, Florida, United States, 32751
- Active, not recruiting
- ClinCloud Research
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Miami, Florida, United States, 33165
- Active, not recruiting
- Alma Clinical Research Inc
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Miami Lakes, Florida, United States, 33014
- Recruiting
- Inpatient Research Clinical LLC
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Principal Investigator:
- Alexis Gutierrez
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Contact:
- Sergio Ramirez
- Phone Number: 786-502-4303
- Email: sramirez@inpatientresearch.com
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North Miami Beach, Florida, United States, 33162
- Active, not recruiting
- Harmony Clinical Research
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Plant City, Florida, United States, 33563
- Active, not recruiting
- Fam Medical Specialists Of Fl Plc
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Zephyrhills, Florida, United States, 33541
- Active, not recruiting
- Cozy Research LLC .
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Georgia
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Atlanta, Georgia, United States, 30315
- Withdrawn
- Sonar Clinical Research LLC
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Illinois
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Morton, Illinois, United States, 61550
- Active, not recruiting
- Koch Family Medicine
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Louisiana
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Bossier City, Louisiana, United States, 71111
- Active, not recruiting
- Grace Research Llc .
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Shreveport, Louisiana, United States, 71101
- Active, not recruiting
- Grace Research Llc .
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Zachary, Louisiana, United States, 70791
- Active, not recruiting
- Southern Clinical Research Clinic .
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New York
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Bronx, New York, United States, 10456
- Active, not recruiting
- Prime Global Research Inc
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North Carolina
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Monroe, North Carolina, United States, 28112
- Active, not recruiting
- Monroe Biomedical Research .
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North Dakota
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Fargo, North Dakota, United States, 58103
- Active, not recruiting
- Lillestol Research, LLC .
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Ohio
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Huber Heights, Ohio, United States, 45424
- Active, not recruiting
- WellNow Urgent Care and Research Research Department
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Oklahoma
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Edmond, Oklahoma, United States, 73013
- Active, not recruiting
- Conrad Clinical Research Research
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Tennessee
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Nashville, Tennessee, United States, 37203
- Active, not recruiting
- Compass Point Research Brengle Family Med and Rsch
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Texas
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Lufkin, Texas, United States, 75904
- Withdrawn
- Novartis Investigative Site
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Sugar Land, Texas, United States, 77479
- Active, not recruiting
- Mt Olympus Medical Research
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Virginia
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Richmond, Virginia, United States, 23219
- Active, not recruiting
- Dominion Medical Associates
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Wisconsin
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West Bend, Wisconsin, United States, 53095
- Active, not recruiting
- Spaulding Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria to be met at screening:
- informed consent must be signed prior to participation in study
- fasting LDL-C of >= 100mg/dL but < 190mg/dL
- fasting triglycerides <= 400 mg/dL
- 10-year ASCVD risk score < 7.5%
- not on any lipid-lowering therapy within 90 days
Key Exclusion Criteria:
- 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)
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inclisiran
Inclisiran s.c and Placebo p.o
|
284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
Other Names:
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Other Names:
|
Active Comparator: Ezetimibe
Placebo s.c. and Ezetimibe p.o.
|
10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
Other Names:
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
Other Names:
|
Placebo Comparator: Placebo
Placebo s.c. and Placebo p.o.
|
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Other Names:
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150 compared with placebo
Time Frame: Baseline, Day 150
|
Percentage change in LDL-C from Baseline (Day 1) to Day 150 comparing Inclisiran arm versus Placebo arm
|
Baseline, Day 150
|
Percentage change in LDL-C from Baseline to Day 150 compared with ezetimibe
Time Frame: Baseline, Day 150
|
Percentage change in LDL-C from Baseline (Day 1) to Day 150 comparing Inclisiran arm versus Ezetimibe arm.
|
Baseline, Day 150
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute change in LDL-C from Baseline to Day 150
Time Frame: Baseline, Day 150
|
Absolute change in LDL-C from Baseline (Day 1) to Day 150 compared to ezetimibe and placebo
|
Baseline, Day 150
|
Percentage change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline to Day 150
Time Frame: Baseline, Day 150
|
Percentage change in PCSK9 from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
|
Baseline, Day 150
|
Percentage change in non-High-Density Lipoprotein Cholesterol (non-HDL-C) from Baseline to Day 150
Time Frame: Baseline, Day 150
|
Percentage change in non-HDL-C from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
|
Baseline, Day 150
|
Percentage change in Total Cholesterol (TC)/HDL-C ratio from Baseline to Day 150
Time Frame: Baseline, Day 150
|
Percentage change in total cholesterol (TC)/HDL-C ratio from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
|
Baseline, Day 150
|
Percentage change in Apolipoprotein B (Apo B) from Baseline to Day 150
Time Frame: Baseline, Day 150
|
Percentage change in Apo B from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
|
Baseline, Day 150
|
Percentage change in Apo B/Apo A-1 ratio from Baseline to Day 150
Time Frame: Baseline, Day 150
|
Percentage change in Apo B/Apo A-1 ratio from baseline (Day 1) and Day 150 compared to ezetimibe and placebo
|
Baseline, Day 150
|
Percentage change in Lipoprotein (a) [Lp(a)] from Baseline to Day 150
Time Frame: Baseline, Day 150
|
Percentage change in Lp(a) from Baseline (Day 1) and Day 150 compared to ezetimibe and placebo
|
Baseline, Day 150
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CKJX839D12304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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