Primary HypercholesterolemiaVICTORION REALNCT05399992
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
An observational study of Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 40 sites in 8 countries.
Trial summary
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- What is being tested?
- Inclisiran
- How many people
- 847 participants
- Where
- 40 sitesin 8 countries
- Study dates
- 12 Sep 2022to 23 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult participants with an underlying diagnosis of Atherosclerotic Cardiovascular Disease (ASCVD), ASCVD risk equivalent (ASCVD RE), or Heterozygous familial hypercholesterolemia (HeFH) and elevated levels of Low density lipoprotein - Cholesterol (LDL-C)
Who may be able to join
- Participants who are 18 years or older
- Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
- Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
- Participants who per physician's criteria need to optimize their LLT
- Participants who provide written informed consent to participate in the study
- Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.
Who cannot join
- Participants that have received inclisiran previously
- Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)
Trial locations and contacts
40 sites in 8 countries.
40 sites in 8 countries
United Kingdom12 sites
Novartis Investigative Site
Belfast, BT16 1RH
Novartis Investigative Site
Bromwich, B71 4HJ
Novartis Investigative Site
Burton-on-Trent, DE13 0RB
Novartis Investigative Site
High Wycombe, Buckinghamshire, HP11 2TR
Novartis Investigative Site
Hull, HU3 2RW
Novartis Investigative Site
Lancaster, LA1 4RP
Novartis Investigative Site
Liverpool, L7 8XP
Novartis Investigative Site
London, NW3 2QG
Novartis Investigative Site
Louth, Lincolnshire, LN11 7QU
Novartis Investigative Site
Middlesex, UB9 6JH
Novartis Investigative Site
Portadown, Nothern Ireland, BT63 5QQ
Novartis Investigative Site
Sunderland, Tyne and Wear, SR4 7TP
Switzerland8 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Fribourg, CH, 1708
Novartis Investigative Site
Geneva, 1211
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Olten, 4600
Novartis Investigative Site
Sankt Gallen, 9007
Novartis Investigative Site
Zurich, 8032
Novartis Investigative Site
Zurich, 8091
Austria6 sites
Novartis Investigative Site
Feldkirch, 6807
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Linz, 4021
Novartis Investigative Site
Sankt Veit im Pongau, 5621
Novartis Investigative Site
Vienna, 1090
Novartis Investigative Site
Vienna, 1180
United Arab Emirates5 sites
Novartis Investigative Site
Abu Dhabi, 00000
Novartis Investigative Site
Abu Dhabi
Novartis Investigative Site
Al Ain City
Novartis Investigative Site
Dubai, 000000
Novartis Investigative Site
Dubai
Israel3 sites
Novartis Investigative Site
Holon, Gush Dan, 5845997
Novartis Investigative Site
Petah Tikva, 4941492
Novartis Investigative Site
Tel Aviv, 6801296
Saudi Arabia3 sites
Novartis Investigative Site
Jeddah, 23311
Novartis Investigative Site
Riyadh, Saudi, 11643
Novartis Investigative Site
Tabuk, 47512
Malaysia2 sites
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50470
Novartis Investigative Site
Kuala Lumpur, 50400
About this study
Official title: VICTORION REAL: An International Prospective Real-world Study to Evaluate the LDL-C changE and Adherence to incLisiran in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.
Read the detailed description
Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Being tested
- Inclisiran
- Keywords
- primary hypercholesterolemia, mixed dyslipidemia, real-world study, inclisiran, lipid-lowering therapy, LLT, ASCVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranOther
Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study.
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran cohort | Participants prescribed inclisiran alone or with other LLTs as per approved label Receives: Other: Inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in LDL-C from baseline to 10 months
Percentage change in Low density lipoprotein - Cholesterol (LDL-C)
Measured: Baseline, 10 months
Secondary outcomes (18)
Percentage change in LDL-C from baseline
Percentage change in LDL-C from baseline is collected
Measured: Baseline, month 4, month 16, month 22
Percentage change in LDL-C from baseline by ≥50%
Percentage change in LDL-C from baseline by ≥50%
Measured: Month 4, month 10, month 16, month 22
Percentage change in LDL-C from baseline by ≥30%
Percentage change in LDL-C from baseline by ≥30%
Measured: Month 4, month 10, month 16, month 22
Proportion of participants achieving LDL-C<55 mg/dL
Proportion of participants achieving LDL-C<55 mg/dL
Measured: Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22
Proportion of participants achieving LDL-C<70 mg/dL
Proportion of participants achieving LDL-C<70 mg/dL
Measured: Month 4, month 10, month 16 and month 22
Time-averaged percentage change in LDL-C from baseline
Time-averaged percentage change in LDL-C from baseline
Measured: Baseline, month 4, month 10, month 16 and month 22
Proportion of participants achieving ≥50% reduction in LDL- C at month 10 and maintaining this at 16, 22 and 24 months
Proportion of participants achieving ≥50% reduction in LDL C at month 10 and maintaining this at 16, 22 and 24 months
Measured: Month 10, month 16, month 22 and month 24
Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months
Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months
Measured: Baseline, month 10, month 24
Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months
Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months
Measured: Month 10 and month 24
Inclisiran cohort : Percentage of days covered by inclisiran
Inclisiran cohort : Percentage of days covered by inclisiran
Measured: 12 months and 24 months
Inclisiran cohort : Mean PDC
Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected
Measured: 12 months and 24 months
Inclisiran cohort : Proportion of participants with a PDC ≥ 80%
Proportion of participants with a PDC ≥ 80% (sensitivity: 90%/100%)
Measured: 12 months and 24 months
Proportion of participants remaining on initial baseline therapy
Proportion of patients remaining on initial baseline therapy in the inclisiran cohort
Measured: Baseline, month 12 and month 24
Time to discontinuation of any newly initiated therapies
Time to discontinuation of any newly initiated therapies
Measured: Month 12 and month 24
Time to discontinuation of any newly initiated therapies by specific LLT
Time to discontinuation of any newly initiated therapies by specific LLT
Measured: Month 12 and month 24
Change from baseline in scores from the TSQM (modified) instrument
The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction.
TSQM V1.4 has a score range of 0 to 100 with with higher scores indicating higher patient satisfaction with medication.
Measured: Baseline, month 12 and month 24
Descriptive adherence data based on Adherence AAQ
Adherence Assessment Questionnaires (AAQ) measures the degree of identified non-adherence to LLT therapy.
AAQ has a score range from 0 (not adherent at all) to 100 (absolute adherent).
Measured: Month 12 and month 24
Descriptive adherence data based on ABQ
Adherence Barriers Questionnaire (ABQ) is an instrument for identifying specific barriers to medication-related adherence.
ABQ is a descriptive analysis. The number and proportion of patients affected by each barrier will be reported for inclisiran participants.
Measured: Month 12 and month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start12 Sep 2022
- Primary completion23 Nov 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 847 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399992
- Sponsor's protocol ID
- CKJX839A12401
- Acronym
- VICTORION REAL
- Status last verified
- Nov 2026
- First submitted
- 27 May 2022
- Last updated
- 6 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VICTORION REAL: An International Prospective Real-world Study to Evaluate the LDL-C changE and Adherence to incLisiran in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT05399992
- Acronym / sponsor ID
- VICTORION REAL / CKJX839A12401
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Keywords
- primary hypercholesterolemia, mixed dyslipidemia, real-world study, inclisiran, lipid-lowering therapy, LLT, ASCVD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 847 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 23 Nov 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.
Detailed description
Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inclisiran cohort | – | Other: InclisiranParticipants prescribed inclisiran alone or with other LLTs as per approved label |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult participants with an underlying diagnosis of Atherosclerotic Cardiovascular Disease (ASCVD), ASCVD risk equivalent (ASCVD RE), or Heterozygous familial hypercholesterolemia (HeFH) and elevated levels of Low density lipoprotein - Cholesterol (LDL-C)
Key inclusion criteria (6 listed)
- Participants who are 18 years or older
- Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
- Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
- Participants who per physician's criteria need to optimize their LLT
- Participants who provide written informed consent to participate in the study
Key exclusion criteria (2 listed)
- Participants that have received inclisiran previously
- Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InclisiranProspective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study. | Other | Inclisiran cohort |
Primary outcome
Percentage change in LDL-C from baseline to 10 months
Time frame: Baseline, 10 months
Percentage change in Low density lipoprotein - Cholesterol (LDL-C)
18 secondary outcomes
Percentage change in LDL-C from baseline
Time frame: Baseline, month 4, month 16, month 22
Percentage change in LDL-C from baseline by ≥50%
Time frame: Month 4, month 10, month 16, month 22
Percentage change in LDL-C from baseline by ≥30%
Time frame: Month 4, month 10, month 16, month 22
Proportion of participants achieving LDL-C<55 mg/dL
Time frame: Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22
Proportion of participants achieving LDL-C<70 mg/dL
Time frame: Month 4, month 10, month 16 and month 22
Time-averaged percentage change in LDL-C from baseline
Time frame: Baseline, month 4, month 10, month 16 and month 22
Proportion of participants achieving ≥50% reduction in LDL- C at month 10 and maintaining this at 16, 22 and 24 months
Time frame: Month 10, month 16, month 22 and month 24
Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months
Time frame: Baseline, month 10, month 24
Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months
Time frame: Month 10 and month 24
Inclisiran cohort : Percentage of days covered by inclisiran
Time frame: 12 months and 24 months
Inclisiran cohort : Mean PDC
Time frame: 12 months and 24 months
Inclisiran cohort : Proportion of participants with a PDC ≥ 80%
Time frame: 12 months and 24 months
Proportion of participants remaining on initial baseline therapy
Time frame: Baseline, month 12 and month 24
Time to discontinuation of any newly initiated therapies
Time frame: Month 12 and month 24
Time to discontinuation of any newly initiated therapies by specific LLT
Time frame: Month 12 and month 24
Change from baseline in scores from the TSQM (modified) instrument
Time frame: Baseline, month 12 and month 24
Descriptive adherence data based on Adherence AAQ
Time frame: Month 12 and month 24
Descriptive adherence data based on ABQ
Time frame: Month 12 and month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
40 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 40 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United Kingdom, Switzerland, Austria, United Arab Emirates, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in LDL-C from baseline to 10 months (time frame: Baseline, 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.