HypercholesterolemiaPhase 4PCSK9-DUONCT07581808
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
A Phase 4 study testing Inclisiran and Alirocumab in people with Hypercholesterolemia and Atherosclerotic Cardiovascular Disease (ASCVD), run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease (ASCVD)
- What is being tested?
- Inclisiran and Alirocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- 18 May 2026to Jun 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Established atherosclerotic cardiovascular disease (secondary prevention), defined as prior cardiovascular events or imaging-confirmed atherosclerosis (e.g., coronary artery disease on angiography or CT, carotid plaque on ultrasound, or peripheral arterial disease).
- Eligible for PCSK9 inhibitor therapy according to national clinical criteria
- Fasting LDL cholesterol ≥2.5 mmol/L and ≤5.0 mmol/L at screening
- Documented statin intolerance or contraindication to statin therapy
- On stable background lipid-lowering therapy (including ezetimibe if applicable) for at least 4 weeks prior to enrollment
- Able and willing to provide written informed consent
Who cannot join
- Eligibility for PCSK9 inhibitor therapy solely based on elevated lipoprotein(a) >1000 mg/L with LDL-C below inclusion threshold
- Prior use of any PCSK9 inhibitor (alirocumab, evolocumab or inclisiran) before enrollment
- Planned initiation or modification of lipid-lowering therapy during the study period
- Known homozygous familial hypercholesterolemia
- Active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3× upper limit of normal
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
Show all 11Show fewer
- Active malignancy or life expectancy <1 year
- Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception
- Known hypersensitivity to inclisiran, alirocumab, or any of their excipients
- Participation in another interventional clinical trial within 30 days prior to enrollment
- Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jan Kafol, MD contact
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Zlatko Fras, MD, PhD, +386 1 522 25 62, zlatko.fras@kclj.si
Jan Kafol, MD, jan.kafol@kclj.si
About this study
Official title: PCSK9-DUO Trial: Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Patients With High Cardiovascular Risk in Secondary Prevention
This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins.
Lowering low-density lipoprotein cholesterol (LDL-C) is essential to reduce the risk of cardiovascular events. While PCSK9 inhibitors are effective, many patients treated with a single agent do not reach recommended LDL-C targets, especially those who cannot take statins.
Read more
Inclisiran and alirocumab reduce LDL-C through different mechanisms. Inclisiran decreases the production of PCSK9 in the liver, while alirocumab binds circulating PCSK9 in the blood. Combining these therapies may lead to a greater reduction in LDL-C levels.
In this randomized, open-label clinical trial, approximately 60 patients in secondary prevention will be assigned to one of three groups: inclisiran alone, alirocumab alone, or a combination of both treatments. Patients will be followed for 9 months with regular clinical and laboratory assessments.
The main goal of the study is to determine whether combination therapy leads to greater LDL-C reduction compared to each treatment alone. Secondary objectives include assessing the proportion of patients achieving target LDL-C levels and evaluating treatment safety and tolerability.
Read the detailed description
Atherosclerotic cardiovascular disease remains a leading cause of morbidity and mortality, with elevated low-density lipoprotein cholesterol (LDL-C) being a major modifiable risk factor. Despite the availability of effective lipid-lowering therapies, a substantial proportion of high-risk patients fail to achieve recommended LDL-C targets, particularly those with statin intolerance.
Proprotein convertase subtilisin/kexin type 9 (PCSK9) plays a key role in regulating LDL receptor degradation and plasma LDL-C levels. Pharmacological inhibition of PCSK9 has emerged as an effective strategy to reduce LDL-C. Two distinct therapeutic approaches are currently available: monoclonal antibodies (such as alirocumab), which neutralize circulating PCSK9, and small interfering RNA therapies (such as inclisiran), which reduce hepatic production of PCSK9.
Although both approaches have demonstrated efficacy, real-world data suggest that monotherapy may not be sufficient for many high-risk patients. The combination of these two mechanisms may provide additive or synergistic effects, leading to more profound LDL-C reduction.
This study is designed as a prospective, randomized, open-label, monocentric clinical trial. Approximately 60 adult patients in secondary prevention with statin intolerance and elevated LDL-C (2.5-5.0 mmol/L) will be enrolled. Participants will be randomized in a 1:1:1 ratio to receive inclisiran, alirocumab, or a combination of both therapies.
Inclisiran will be administered subcutaneously at baseline and at 3 months. Alirocumab will be administered subcutaneously at a dose of 300 mg every 4 weeks in a supervised clinical setting. Patients will be followed for 9 months, with study visits at baseline, 1 month, 3 months, 6 months, and 9 months.
The primary endpoint is the percentage change in LDL-C from baseline at 3 and 9 months. Secondary endpoints include the proportion of patients achieving guideline-recommended LDL-C targets, changes in other lipid parameters, and safety outcomes including adverse events and treatment tolerability.
This study aims to provide proof-of-concept evidence on the effectiveness and safety of dual PCSK9 inhibition using complementary mechanisms, with potential implications for improving lipid management in high-risk, statin-intolerant patients.
- Being tested
- Inclisiran, Alirocumab
- Keywords
- Alirocumab, Inclisiran, LDL cholesterol, Secondary prevention, Statin intolerance
- Medical subject headings
- Hypercholesterolemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranDrug
Participants receive inclisiran 284 mg administered subcutaneously at baseline (Day 0) and at Month 3.
AlirocumabDrug
Participants receive alirocumab 300 mg administered subcutaneously every four weeks in a supervised clinical setting for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran | Experimental | Participants receive inclisiran 284 mg administered subcutaneously at baseline and at 3 months. Patients will be followed for 9 months with scheduled clinical and laboratory assessments. Receives: Drug: Inclisiran |
| Alirocumab | Experimental | Participants receive alirocumab 300 mg administered subcutaneously every four weeks in a supervised clinical setting for 9 months. Patients will be followed with regular clinical and laboratory assessments. Receives: Drug: Alirocumab |
| Inclisiran Plus Alirocumab | Experimental | Participants receive inclisiran 284 mg administered subcutaneously at baseline and at 3 months, in combination with alirocumab 300 mg administered subcutaneously every four weeks in a supervised clinical setting for 9 months. Patients will be followed with scheduled clinical and laboratory assessments. Receives: Drug: Inclisiran; Drug: Alirocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in LDL-C From Baseline
Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline at 3 months and 9 months, comparing inclisiran, alirocumab, and combination therapy.
Measured: 3 months and 9 months
Secondary outcomes (10)
Trajectory of Percent Change in LDL-C From Baseline
Percent change in LDL-C from baseline at each scheduled follow-up visit to assess early response and durability of treatment effect.
Measured: 1, 3, 6, and 9 months
Change From Baseline in LDL-C Concentration
Absolute change in LDL-C concentration compared with baseline at each scheduled follow-up visit.
Measured: 1, 3, 6, and 9 months
Proportion of Participants Achieving LDL-C <1.4 mmol/L
Proportion of participants achieving LDL-C below 1.4 mmol/L at each scheduled follow-up visit.
Measured: 1, 3, 6, and 9 months
Change in Apolipoprotein B From Baseline
Absolute and percent change in apolipoprotein B from baseline.
Measured: 1, 3, 6, and 9 months
Change in Non-HDL Cholesterol From Baseline
Absolute and percent change in non-HDL cholesterol from baseline.
Measured: 1, 3, 6, and 9 months
Change in Lipoprotein(a) From Baseline
Absolute and percent change in lipoprotein(a) from baseline.
Measured: 1, 3, 6, and 9 months
Change From Baseline in Total Cholesterol, HDL Cholesterol, and Triglyceride Concentrations
Change in serum total cholesterol, HDL cholesterol, and triglyceride concentrations compared with baseline values.
Measured: 1, 3, 6, and 9 months
Incidence of Adverse Events
Number and proportion of participants experiencing any adverse event during the study.
Measured: Up to 9 months
Treatment Discontinuation Due to Adverse Events
Proportion of participants who discontinue assigned study treatment because of adverse events.
Measured: Up to 9 months
Change in Circulating PCSK9 Concentration From Baseline
Absolute and percent change in circulating PCSK9 concentration to assess pharmacodynamic effects of treatment.
Measured: 1, 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start18 May 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three parallel treatment groups: inclisiran monotherapy, alirocumab monotherapy, or combined inclisiran and alirocumab therapy. Randomization will be stratified by baseline LDL-C (\<3.6 vs ≥3.6 mmol/L) and background ezetimibe use (yes/no) using permuted block randomization.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zlatko Fras, MD, PhD, Study chair, University Medical Centre LjubljanaJan Kafol, MD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581808
- Sponsor's protocol ID
- UKC-PCSK9-DUO
- Acronym
- PCSK9-DUO
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request to qualified researchers. Data sharing will be subject to approval by the study investigators and institutional policies, and will require a data use agreement to ensure appropriate use and protection of participant confidentiality.
Publications
Kafol J, Fras Z, Novakovic M, Sperling LS, Cevc M, Krevel B, Kafol L, Kelenc A, Kepic K, Vrbinc K, Svarc M, Groselj U, Jug B. Real-world effectiveness and cardiovascular outcomes of PCSK9 inhibitor therapy: a prospective registry study. Lipids Health Dis. 2026 Mar 5;25(1):106. doi: 10.1186/s12944-026-02897-3.
PubMed 41787544Mach F, Koskinas KC, Roeters van Lennep JE, Tokgozoglu L, Badimon L, Baigent C, Benn M, Binder CJ, Catapano AL, De Backer GG, Delgado V, Fabin N, Ference BA, Graham IM, Landmesser U, Laufs U, Mihaylova B, Nordestgaard BG, Richter DJ, Sabatine MS; ESC/EAS Scientific Document Group. 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2025 Nov 7;46(42):4359-4378. doi: 10.1093/eurheartj/ehaf190. No abstract available.
PubMed 40878289Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
PubMed 31504418Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, Stroes ES, Langslet G, Raal FJ, El Shahawy M, Koren MJ, Lepor NE, Lorenzato C, Pordy R, Chaudhari U, Kastelein JJ; ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. doi: 10.1056/NEJMoa1501031. Epub 2015 Mar 15.
PubMed 25773378Wright RS, Raal FJ, Koenig W, Landmesser U, Leiter LA, Vikarunnessa S, Lesogor A, Maheux P, Talloczy Z, Zang X, Schwartz GG, Ray KK. Inclisiran administration potently and durably lowers LDL-C over an extended-term follow-up: the ORION-8 trial. Cardiovasc Res. 2024 Oct 14;120(12):1400-1410. doi: 10.1093/cvr/cvae109.
PubMed 38753448Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PLJ, Kastelein JJP; ORION-10 and ORION-11 Investigators. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020 Apr 16;382(16):1507-1519. doi: 10.1056/NEJMoa1912387. Epub 2020 Mar 18.
PubMed 32187462
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCSK9-DUO Trial: Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Patients With High Cardiovascular Risk in Secondary Prevention
- ClinicalTrials.gov ID
- NCT07581808
- Acronym / sponsor ID
- PCSK9-DUO / UKC-PCSK9-DUO
- Keywords
- Alirocumab, Inclisiran, LDL cholesterol, Secondary prevention, Statin intolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 May 2026 (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 study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins.
Lowering low-density lipoprotein cholesterol (LDL-C) is essential to reduce the risk of cardiovascular events. While PCSK9 inhibitors are effective, many patients treated with a single agent do not reach recommended LDL-C targets, especially those who cannot take statins.
Inclisiran and alirocumab reduce LDL-C through different mechanisms. Inclisiran decreases the production of PCSK9 in the liver, while alirocumab binds circulating PCSK9 in the blood. Combining these therapies may lead to a greater reduction in LDL-C levels.
In this randomized, open-label clinical trial, approximately 60 patients in secondary prevention will be assigned to one of three groups: inclisiran alone, alirocumab alone, or a combination of both treatments. Patients will be followed for 9 months with regular clinical and laboratory assessments.
The main goal of the study is to determine whether combination therapy leads to greater LDL-C reduction compared to each treatment alone. Secondary objectives include assessing the proportion of patients achieving target LDL-C levels and evaluating treatment safety and tolerability.
Detailed description
Atherosclerotic cardiovascular disease remains a leading cause of morbidity and mortality, with elevated low-density lipoprotein cholesterol (LDL-C) being a major modifiable risk factor. Despite the availability of effective lipid-lowering therapies, a substantial proportion of high-risk patients fail to achieve recommended LDL-C targets, particularly those with statin intolerance.
Proprotein convertase subtilisin/kexin type 9 (PCSK9) plays a key role in regulating LDL receptor degradation and plasma LDL-C levels. Pharmacological inhibition of PCSK9 has emerged as an effective strategy to reduce LDL-C. Two distinct therapeutic approaches are currently available: monoclonal antibodies (such as alirocumab), which neutralize circulating PCSK9, and small interfering RNA therapies (such as inclisiran), which reduce hepatic production of PCSK9.
Although both approaches have demonstrated efficacy, real-world data suggest that monotherapy may not be sufficient for many high-risk patients. The combination of these two mechanisms may provide additive or synergistic effects, leading to more profound LDL-C reduction.
This study is designed as a prospective, randomized, open-label, monocentric clinical trial. Approximately 60 adult patients in secondary prevention with statin intolerance and elevated LDL-C (2.5-5.0 mmol/L) will be enrolled. Participants will be randomized in a 1:1:1 ratio to receive inclisiran, alirocumab, or a combination of both therapies.
Inclisiran will be administered subcutaneously at baseline and at 3 months. Alirocumab will be administered subcutaneously at a dose of 300 mg every 4 weeks in a supervised clinical setting. Patients will be followed for 9 months, with study visits at baseline, 1 month, 3 months, 6 months, and 9 months.
The primary endpoint is the percentage change in LDL-C from baseline at 3 and 9 months. Secondary endpoints include the proportion of patients achieving guideline-recommended LDL-C targets, changes in other lipid parameters, and safety outcomes including adverse events and treatment tolerability.
This study aims to provide proof-of-concept evidence on the effectiveness and safety of dual PCSK9 inhibition using complementary mechanisms, with potential implications for improving lipid management in high-risk, statin-intolerant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three parallel treatment groups: inclisiran monotherapy, alirocumab monotherapy, or combined inclisiran and alirocumab therapy. Randomization will be stratified by baseline LDL-C (<3.6 vs ≥3.6 mmol/L) and background ezetimibe use (yes/no) using permuted block randomization.
| Arm | Type | Receives |
|---|---|---|
| Inclisiran | Experimental | Drug: InclisiranParticipants receive inclisiran 284 mg administered subcutaneously at baseline and at 3 months. Patients will be followed for 9 months with scheduled clinical and laboratory assessments. |
| Alirocumab | Experimental | Drug: AlirocumabParticipants receive alirocumab 300 mg administered subcutaneously every four weeks in a supervised clinical setting for 9 months. Patients will be followed with regular clinical and laboratory assessments. |
| Inclisiran Plus Alirocumab | Experimental | Drug: Inclisiran, Drug: AlirocumabParticipants receive inclisiran 284 mg administered subcutaneously at baseline and at 3 months, in combination with alirocumab 300 mg administered subcutaneously every four weeks in a supervised clinical setting for 9 months. Patients will be followed with scheduled clinical and laboratory assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged ≥18 years
- Established atherosclerotic cardiovascular disease (secondary prevention), defined as prior cardiovascular events or imaging-confirmed atherosclerosis (e.g., coronary artery disease on angiography or CT, carotid plaque on ultrasound, or peripheral arterial disease).
- Eligible for PCSK9 inhibitor therapy according to national clinical criteria
- Fasting LDL cholesterol ≥2.5 mmol/L and ≤5.0 mmol/L at screening
- Documented statin intolerance or contraindication to statin therapy
Key exclusion criteria (11 listed)
- Eligibility for PCSK9 inhibitor therapy solely based on elevated lipoprotein(a) >1000 mg/L with LDL-C below inclusion threshold
- Prior use of any PCSK9 inhibitor (alirocumab, evolocumab or inclisiran) before enrollment
- Planned initiation or modification of lipid-lowering therapy during the study period
- Known homozygous familial hypercholesterolemia
- Active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3× upper limit of normal
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 |
|---|---|---|
| InclisiranParticipants receive inclisiran 284 mg administered subcutaneously at baseline (Day 0) and at Month 3. | Drug | Inclisiran, Inclisiran Plus Alirocumab |
| AlirocumabParticipants receive alirocumab 300 mg administered subcutaneously every four weeks in a supervised clinical setting for 9 months. | Drug | Alirocumab, Inclisiran Plus Alirocumab |
Primary outcome
Percent Change in LDL-C From Baseline
Time frame: 3 months and 9 months
Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline at 3 months and 9 months, comparing inclisiran, alirocumab, and combination therapy.
10 secondary outcomes
Trajectory of Percent Change in LDL-C From Baseline
Time frame: 1, 3, 6, and 9 months
Change From Baseline in LDL-C Concentration
Time frame: 1, 3, 6, and 9 months
Proportion of Participants Achieving LDL-C <1.4 mmol/L
Time frame: 1, 3, 6, and 9 months
Change in Apolipoprotein B From Baseline
Time frame: 1, 3, 6, and 9 months
Change in Non-HDL Cholesterol From Baseline
Time frame: 1, 3, 6, and 9 months
Change in Lipoprotein(a) From Baseline
Time frame: 1, 3, 6, and 9 months
Change From Baseline in Total Cholesterol, HDL Cholesterol, and Triglyceride Concentrations
Time frame: 1, 3, 6, and 9 months
Incidence of Adverse Events
Time frame: Up to 9 months
Treatment Discontinuation Due to Adverse Events
Time frame: Up to 9 months
Change in Circulating PCSK9 Concentration From Baseline
Time frame: 1, 3, 6, and 9 months
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 2 Jun 2026.
- Background: PubMed 41787544Kafol J, Fras Z, Novakovic M, Sperling LS, Cevc M, Krevel B, Kafol L, Kelenc A, Kepic K, Vrbinc K, Svarc M, Groselj U, Jug B. Real-world effectiveness and cardiovascular outcomes of PCSK9 inhibitor therapy: a prospective registry study. Lipids Health Dis. 2026 Mar 5;25(1):106. doi: 10.1186/s12944-026-02897-3.
- Background: PubMed 40878289Mach F, Koskinas KC, Roeters van Lennep JE, Tokgozoglu L, Badimon L, Baigent C, Benn M, Binder CJ, Catapano AL, De Backer GG, Delgado V, Fabin N, Ference BA, Graham IM, Landmesser U, Laufs U, Mihaylova B, Nordestgaard BG, Richter DJ, Sabatine MS; ESC/EAS Scientific Document Group. 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2025 Nov 7;46(42):4359-4378. doi: 10.1093/eurheartj/ehaf190. No abstract available.
- Background: PubMed 31504418Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
- Background: PubMed 25773378Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, Stroes ES, Langslet G, Raal FJ, El Shahawy M, Koren MJ, Lepor NE, Lorenzato C, Pordy R, Chaudhari U, Kastelein JJ; ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. doi: 10.1056/NEJMoa1501031. Epub 2015 Mar 15.
- Background: PubMed 38753448Wright RS, Raal FJ, Koenig W, Landmesser U, Leiter LA, Vikarunnessa S, Lesogor A, Maheux P, Talloczy Z, Zang X, Schwartz GG, Ray KK. Inclisiran administration potently and durably lowers LDL-C over an extended-term follow-up: the ORION-8 trial. Cardiovasc Res. 2024 Oct 14;120(12):1400-1410. doi: 10.1093/cvr/cvae109.
- Background: PubMed 32187462Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PLJ, Kastelein JJP; ORION-10 and ORION-11 Investigators. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020 Apr 16;382(16):1507-1519. doi: 10.1056/NEJMoa1912387. Epub 2020 Mar 18.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request to qualified researchers. Data sharing will be subject to approval by the study investigators and institutional policies, and will require a data use agreement to ensure appropriate use and protection of participant confidentiality.
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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.
Jan Kafol, MD contact
Zlatko Fras, MD, PhD study chair
University Medical Centre Ljubljana
Jan Kafol, MD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inclisiran and Alirocumab in people with Hypercholesterolemia and Atherosclerotic Cardiovascular Disease (ASCVD), run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Zlatko Fras, MD, PhD (+386 1 522 25 62, zlatko.fras@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in LDL-C From Baseline (time frame: 3 months and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07581808, which also lists 6 linked publications.
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 2 Jun 2026.