NCT05763875CompletedPhase 3
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
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)
Source: ClinicalTrials.gov · Last updated 16 Oct 2025
Brief summary (registry, in English)
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%.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 350 (actual)
- First submitted
- 28 Feb 2023
- Start date
- 15 Mar 2023
- Primary completion date
- 20 Jun 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05763875
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 350
- From 15 Mar 2023 to the primary completion date, 20 Jun 2024
- 41 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of ASCVD
Lab values
- diabetes mellitus or fasting plasma glucose of \>= 7.0 mmol/L or HbA1c \>= 6.5%
Other
- secondary hypercholesterolemia, e.g. hypothyroidism (TSH above upper limit of normal)
Who the study is looking for
- informed consent signed prior to participation in study
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| - Coordinator of this site? Confirm its status | Floridablanca | Colombia | Unknown status |
| - Coordinator of this site? Confirm its status | Manizales | Colombia | Unknown status |
| - Coordinator of this site? Confirm its status | San Gil | Colombia | Unknown status |
| - Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Gladbeck | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Jerichow | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Löhne | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Papenburg | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| - Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| - Coordinator of this site? Confirm its status | Culiacan Sinaloa | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Querétaro | Mexico | Unknown status |
| Parkway Medical Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Grace Research LLC Coordinator of this site? Confirm its status | Bossier City | United States | Unknown status |
| Hillcrest Medical Research Coordinator of this site? Confirm its status | DeLand | United States | Unknown status |
| SEC Clinical Research Coordinator of this site? Confirm its status | Dothan | United States | Unknown status |
| Conrad Clinical Research Coordinator of this site? Confirm its status | Edmond | United States | Unknown status |
| Lillestol Research, LLC Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| WellNow Urgent Care and Research Coordinator of this site? Confirm its status | Huber Heights | United States | Unknown status |
| ClinCloud Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Alma Clinical Research, Inc. Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Inpatient Research Clinical LLC Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| Koch Family Medicine Coordinator of this site? Confirm its status | Morton | United States | Unknown status |
| Compass Point Research Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Harmony Clinical Research Coordinator of this site? Confirm its status | North Miami Beach | United States | Unknown status |
| Fam Medical Specialists Of Fl Plc Coordinator of this site? Confirm its status | Plant City | United States | Unknown status |
| Dominion Medical Associates Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Grace Research, LLC Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| Mt. Olympus Medical Research Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Prime Global Research Inc. Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Spaulding Clinical Research Coordinator of this site? Confirm its status | West Bend | United States | Unknown status |
| Southern Clin Research Clinic Coordinator of this site? Confirm its status | Zachary | United States | Unknown status |
| Cozy Research LLC Coordinator of this site? Confirm its status | Zephyrhills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.