AzTrials
AzTrials

HypercholesterolemiaPhase 4NCT06431763

A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.

A Phase 4 study testing Inclisiran sodium and BPA in people with Hypercholesterolemia, run by Novartis Pharmaceuticals at 55 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects (≥ 18 years) at very high and high risk for cardiovascular events as defined by the cardiovascular risk categories in the 2019 ESC/EAS guidelines for the management of… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Hypercholesterolemia
What is being tested?
Inclisiran sodium and BPA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
55 sitesGermany
Study dates
21 Jun 2024to 2 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fasting LDL-C ≥ 70 mg/dL at screening
  • Participants must be on a stable (≥ 4 weeks) and well-tolerated lipid-lowering regimen (with or without Ezetimibe [10mg]) that must include a high-intensity statin therapy with either atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD in a maximally tolerated or maximally approved dose at screening
  • Participants categorized as very high or high CV risk, as defined below:
  • Very high risk participants with at least one of the following:
  • Documented ASCVD: ACS: Unstable angina or myocardial infarction, Stable angina, Coronary revascularization, Unequivocally documented ASCVD upon prior imaging, Stroke and Transient Ischaemic Attack (TIA), Peripheral artery disease (PAD)
  • Diabetes mellitus (DM) with target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), or at least ≥ 3 major risk factors, or early onset of Type 1 DM of long duration (< 20 years)
Show all 15Show fewer
  • A calculated SCORE2 ≥ 7.5 % for age < 50 years; SCORE2 ≥ 10 % for age 50-69 years; SCORE2-OP ≥ 15 % for age ≥ 70 years to estimate 10-year risk of fatal and non-fatal CVD
  • Pre-existing diagnosis of heterozygous familial hyper-cholesterolemia (HeFH) with ASCVD or with another major risk factor OR
  • High risk participants with at least one of the following:
  • Markedly elevated single risk factors, in particular total cholesterol > 310 mg/dL, LDL-C > 190 mg/dL, or blood pressure ≥ 180/110 mmHg
  • Pre-existing diagnosis of HeFH without other major risk factors
  • DM without target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), with DM duration ≥ 10 years or other additional risk factor
  • Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2)
  • A calculated SCORE2 2.5 to < 7.5 % for age < 50 years; SCORE2 5 to < 10 % for age 50-69 years; SCORE2-OP 7.5 to < 15 % for age ≥ 70 years to estimate 10-year risk of fatal and non-fatal CVD as defined by the cardiovascular risk categories in the 2019 ESC/EAS guideline (Mach et al 2020), and updated SCORE2 and SCORE2-OP (Hageman et al 2021, de Vries et al 2021, Visseren et al 2021). Further details for documented ASCVD will be provided in the protocol.
  • Fasting triglyceride < 400 mg/dL at screening

Who cannot join

  • Acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 months prior to screening visit or V1.
  • Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary re-vascularization within 6 months after screening visit.
  • Heart failure NYHA class IV at screening or V1.
  • Participants on more than one other lipid-lowering drug on top of statin at screening visit.
  • Previous treatment with a mAb directed towards PCSK9 (e.g., evolocumab, alirocumab) or planned use after screening visit.
  • Previous treatment prior to screening with BPA within 90 days
  • Previous exposure to Inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug.

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

Germany55 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Bad Homburg, 61348

  • Novartis Investigative Site

    Bad Krozingen, 79189

  • Novartis Investigative Site

    Bad Oeynhausen, 32545

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 13347

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bochum, 44789

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bremen, 28277

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50733

  • Novartis Investigative Site

    Dessau, 06846

  • Novartis Investigative Site

    Dresden, Saxony, 01099

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Erfurt, 99097

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45355

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Essen, 45355

  • Novartis Investigative Site

    Falkensee, 14612

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60389

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60594

  • Novartis Investigative Site

    Gladbeck, 45968

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075

  • Novartis Investigative Site

    Hamburg, 21109

  • Novartis Investigative Site

    Hamburg, 22041

  • Novartis Investigative Site

    Hamburg, 22607

  • Novartis Investigative Site

    Hoyerswerda, 02977

  • Novartis Investigative Site

    Jena, Thuringia, 07740

  • Novartis Investigative Site

    Kaiserslautern, Rhineland-Palatinate, 67655

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Leipzig, Saxony, 04209

  • Novartis Investigative Site

    Lichtenfels, Bavaria, 96215

  • Novartis Investigative Site

    Löhne, North Rhine-Westphalia, 32584

  • Novartis Investigative Site

    Ludwigshafen, 67067

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305

  • Novartis Investigative Site

    Markkleeberg, 04416

  • Novartis Investigative Site

    Meissen, 01662

  • Novartis Investigative Site

    Muehldorf Am Inn, Bavaria, 84453

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Offenbach, Hesse, 63065

  • Novartis Investigative Site

    Papenburg, 26871

  • Novartis Investigative Site

    Pirna, 01796

  • Novartis Investigative Site

    Potsdam, 14471

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053

  • Novartis Investigative Site

    Rüdersdorf, 15562

  • Novartis Investigative Site

    Saint Ingbert, Saarland, 66386

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70376

  • Novartis Investigative Site

    Sulzbach-Rosenberg, Bavaria, 92237

  • Novartis Investigative Site

    Ulm, 89077

  • Novartis Investigative Site

    Völklingen, 66333

Other trials in Germany

About this study

Official title: A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of Inclisiran to Bempedoic Acid on LDL Cholesterol (LDL-C) Lowering in Participants With Atherosclerotic Cardiovascular Disease (VICTORION-CHALLENGE)

This study is a phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects (≥ 18 years) at very high and high risk for cardiovascular events as defined by the cardiovascular risk categories in the 2019 ESC/EAS guidelines for the management of dyslipidemias (Mach et al 2020) and elevated levels of LDL-C (≥ 70 mg/dL) despite being on a maximally tolerated high-intensity (HI) statin dose (+/- Ezetimibe). Currently, BPA is recommended ahead of injectables by German HTA body (GBA). A head-to-head trial is proposed to provide robust scientific data on the superiority of Inclisiran vs. BPA and to support the early use of Inclisiran.

Read the detailed description

During the screening period study eligibility will be assessed and the participants' individual LDL-C target according to guideline (Mach et al., 2020) will be determined. Among other criteria, at screening, a participant must be on a stable maximally tolerated dose of a HI statin with either atorvastatin ≥40 mg once a day (QD) or rosuvastatin ≥20 mg QD (+/- Ezetimibe [10mg]) for ≥ 4 weeks with which, however, a target LDL-C of < 70 mg/dL is not reached.

During the open-label treatment period, all participants, who fulfill the inclusion/exclusion criteria, will be randomized at V1 (Day 1) in a 1:1 open-label fashion to either Inclisiran sodium 300 mg s.c. (administered at Day 1 and Day 90) or to BPA tablets 180 mg p.o. (given once daily). Participants will be required to maintain their background lipid-lowering treatment (maximally tolerated statin dose +/- Ezetimibe) unchanged for the duration of the study. The end of treatment (EOT) is reached at day 150.

A Safety-Follow-up call will be conducted 30 days after EOT visit (Day 180).

The overall study duration is approximately 190 days but can vary depending on individual screening and the visit windows allowed for the treatment period and EOS visit.

Being tested
Inclisiran sodium, BPA
Keywords
LDL-cholesterol, atherosclerotic cardiovascular disease, Inclisiran, bempedoic acid, BPA, PCSK9 inhibitor, head-to-head comparison
Medical subject headings
Hypercholesterolemia, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inclisiran sodiumDrug

    Also called PCSK9 inhibitor, siRNA

    300 mg s.c. administered at day 1 and day 90

  • BPADrug

    Also called small molecule, ACL inhibitor

    180 mg daily per oral

Study groups in NCT06431763
Study groupRoleWhat they receive
InclisiranExperimentalInclisiran treatment on top of background treatment (high intensity statin with/without ezetimibe)
Receives: Drug: Inclisiran sodium
Bempedoic acid (BPA)Active comparatorBPA treatment on top of background treatment (high intensity statin with/without ezetimibe)
Receives: Drug: BPA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in LDL-C levels

    To demonstrate superiority of Inclisiran compared to BPA, in combination with standard of care (maximally tolerated HI statin dose +/- Ezetimibe) in reducing relative LDL-C levels at Day 150.

    Measured: Baseline, Day 150

Secondary outcomes (10)

  1. Percent change from baseline in LDL-C levels in patients without Ezetimibe

    To demonstrate superiority of Inclisiran compared to BPA, in patients on maximally tolerated HI statin dose without Ezetimibe in relative reduction of LDL-C levels at Day 150.

    Measured: Baseline, Day 150

  2. Percent change from baseline in LDL-C levels in patients with Ezetimibe

    To demonstrate superiority of Inclisiran compared to BPA, in patients on maximally tolerated HI statin dose with Ezetimibe in reducing relative LDL-C levels at Day 150.

    Measured: Baseline, Day 150

  3. Number of participants by individual responsiveness

    Number of patients who qualify for 'sufficient response' based on their individual risk class, defined through on treatment LDL-C levels.

    For patients classified as 'very high risk', responsiveness is 'achieved' once the LDL-C drops below 55mg/dL, and for patients classified as 'high risk' responsiveness is 'achieved' once the LDL-C < 70 mg/dL at Day 150.

    Measured: Day 150

  4. Absolute change from Baseline in LDL-C

    Assess efficacy of Inclisiran compared to BPA in reducing LDL-C (absolute reduction).

    Measured: Day 150

  5. Percent change from Baseline in LDL-C levels

    Assess efficacy of Inclisiran compared to BPA in reducing LDL-C [time-adjusted percent change] starting Day 30 and up to Day 150.

    Measured: Baseline, from Day 30 up to Day 150

  6. Percent change from Baseline in LDL-C levels

    Assess efficacy of Inclisiran compared to BPA in reducing LDL-C [time-adjusted percent change] between Day 90 and Day 150.

    Measured: Between Day 90 and Day 150

  7. Mean change from baseline in MMAS-8 over time

    Assess adherence to lipid-lowering therapy over time in participants receiving Inclisiran compared to BPA on top of maximally tolerated HI statins (+/- Ezetimibe) using the Morisky 8-Item Medication Adherence Scale (MMAS-8).

    The Morisky Medication Adherence Scale is an assessment tool used to measure non-adherence in patient populations. It consists of seven yes/no questions and one 5-point Likert scale with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence.

    Measured: From Baseline up to Day 150

  8. Mean change from Baseline in TSQM over time

    Assess effect of Inclisiran compared to BPA regarding treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM v. II).

    The TSQM (version II) comprises 11 items across four domains focusing on effectiveness (two items), side effects (four items), convenience (three items), and global satisfaction (two item) of the medication over the previous weeks, or since the patient's last use. With the exception of item 3 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales had a nonneutral midpoint, such that there were more positive response options than negative response options, to allow for precise information to be obtained at the upper end of the score distribution. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Higher scores indicating higher patient satisfaction with medication.

    Measured: From Baseline up to Day 150

  9. Mean change from Baseline in SF-BPI over time

    Assess the effect of Inclisiran compared to BPA regarding pain-related quality of life using the Short Form Brief Pain Inventory (SF-BPI).

    The SF-BPI is a self-administered standardized fifteen items questionnaire that assesses how pain interferes with or influences a participant's life. The SF-BPI includes two main scores: a pain severity score and a pain interference score. The pain severity score combines the information of the four items about pain intensity, which are rated from 0, no pain, to 10, pain as bad as you can imagine. To derive the pain severity score the average of the four items will be taken. The pain interference is calculated similarly using the seven items regarding pain interference, which are rated from 0, does not interfere, to 10, completely interferes. The pain interference score will be the average of these seven items. Both scores will be between 0 and 10. Higher scores correspond to a poorer condition of the participant.

    Measured: From Baseline up to Day 150

  10. Proportion of participants with clinically significant change from Baseline in SF-BPI

    Proportion of participants with clinically significant change from Baseline [Minimal clinically important difference of 2 points] in SF-BPI, to assess the effect of Inclisiran compared to BPA regarding pain-related quality of life using the Short Form Brief Pain Inventory (SF-BPI).

    Measured: At day 150

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start21 Jun 2024
  3. Primary completion1 Dec 2025
  4. Study completion2 Jan 2026

Resources

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
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06431763
Sponsor's protocol ID
CKJX839A1DE02
Other IDs
2024-511076-32-00
Status last verified
Jul 2026
First submitted
30 Apr 2024
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inclisiran sodium and BPA in people with Hypercholesterolemia, run by Novartis Pharmaceuticals at 55 sites in Germany.

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 15 inclusion and 7 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: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent change from baseline in LDL-C levels (time frame: Baseline, Day 150). 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 NCT06431763.

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 29 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in