Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Public ClinicalTrials.gov record NCT05763875. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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%.
Study identification
- NCT ID
- NCT05763875
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Interventions
- Inclisiran Drug
- Ezetimibe Drug
- Matching Placebo for Inclisiran Drug
- Matching Placebo for Ezetimibe Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2023 (Actual)
- Primary completion
- Jun 20, 2024 (Actual)
- Completion
- Jun 20, 2024 (Actual)
- Last update posted
- Oct 16, 2025
2023 – 2024
United States locations
- U.S. sites
- 22
- U.S. states
- 13
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | — |
| SEC Clinical Research | Dothan | Alabama | 36305 | — |
| Hillcrest Medical Research | DeLand | Florida | 32720 | — |
| ClinCloud | Maitland | Florida | 32751 | — |
| Alma Clinical Research Inc | Miami | Florida | 33165 | — |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | 33014 | — |
| Harmony Clinical Research | North Miami Beach | Florida | 33162 | — |
| Fam Medical Specialists Of Fl Plc | Plant City | Florida | 33563 | — |
| Cozy Research LLC | Zephyrhills | Florida | 33541 | — |
| Koch Family Medicine | Morton | Illinois | 61550 | — |
| Grace Research LLC | Bossier City | Louisiana | 71111 | — |
| Grace Research Llc | Shreveport | Louisiana | 71101 | — |
| Southern Clin Research Clinic | Zachary | Louisiana | 70791 | — |
| Prime Global Research Inc | The Bronx | New York | 10456 | — |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | — |
| Lillestol Research LLC | Fargo | North Dakota | 58103 | — |
| WellNow Urgent Care and Research | Huber Heights | Ohio | 45424 | — |
| Conrad Clinical Research | Edmond | Oklahoma | 73013 | — |
| Compass Point Research | Nashville | Tennessee | 37203 | — |
| Mt Olympus Medical Research | Sugar Land | Texas | 77479 | — |
| Dominion Medical Associates | Richmond | Virginia | 23219 | — |
| Spaulding Clinical Research | West Bend | Wisconsin | 53095 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05763875, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2025 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05763875 live on ClinicalTrials.gov.