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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
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

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BarranquillaColombiaUnknown status
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FloridablancaColombiaUnknown status
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ManizalesColombiaUnknown status
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San GilColombiaUnknown status
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BerlinGermanyUnknown status
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BochumGermanyUnknown status
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GladbeckGermanyUnknown status
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HamburgGermanyUnknown status
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HanoverGermanyUnknown status
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JerichowGermanyUnknown status
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LöhneGermanyUnknown status
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MunichGermanyUnknown status
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PapenburgGermanyUnknown status
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BudapestHungaryUnknown status
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PécsHungaryUnknown status
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Culiacan SinaloaMexicoUnknown status
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MéridaMexicoUnknown status
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MonterreyMexicoUnknown status
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QuerétaroMexicoUnknown status
Parkway Medical Center
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BirminghamUnited StatesUnknown status
Grace Research LLC
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Bossier CityUnited StatesUnknown status
Hillcrest Medical Research
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DeLandUnited StatesUnknown status
SEC Clinical Research
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DothanUnited StatesUnknown status
Conrad Clinical Research
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EdmondUnited StatesUnknown status
Lillestol Research, LLC
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FargoUnited StatesUnknown status
WellNow Urgent Care and Research
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Huber HeightsUnited StatesUnknown status
ClinCloud
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MaitlandUnited StatesUnknown status
Alma Clinical Research, Inc.
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MiamiUnited StatesUnknown status
Inpatient Research Clinical LLC
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Miami LakesUnited StatesUnknown status
Monroe Biomedical Research
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MonroeUnited StatesUnknown status
Koch Family Medicine
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MortonUnited StatesUnknown status
Compass Point Research
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NashvilleUnited StatesUnknown status
Harmony Clinical Research
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North Miami BeachUnited StatesUnknown status
Fam Medical Specialists Of Fl Plc
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Plant CityUnited StatesUnknown status
Dominion Medical Associates
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RichmondUnited StatesUnknown status
Grace Research, LLC
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ShreveportUnited StatesUnknown status
Mt. Olympus Medical Research
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Sugar LandUnited StatesUnknown status
Prime Global Research Inc.
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The BronxUnited StatesUnknown status
Spaulding Clinical Research
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West BendUnited StatesUnknown status
Southern Clin Research Clinic
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ZacharyUnited StatesUnknown status
Cozy Research LLC
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ZephyrhillsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.