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Comparing Inclisiran and Bempedoic Acid for Lowering LDL-cholesterol in Heart Disease Patients

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)

Phase 4 Interventional Novartis · NCT06431763

This study is testing whether Inclisiran works better than bempedoic acid at lowering bad cholesterol in heart disease patients who are already on strong statin medications.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsevolocumab, alirocumab
Locations59 sites (Konstanz, Baden Wuerttemberg and 58 other locations)
Trial IDNCT06431763 on ClinicalTrials.gov

What this trial studies

This phase IV, open-label, randomized study aims to evaluate the effectiveness of Inclisiran compared to bempedoic acid (BPA) in lowering LDL-cholesterol levels in 400 adult patients at high risk for cardiovascular events. Participants must be on a stable high-intensity statin regimen and have elevated LDL-C levels despite treatment. The study will randomize participants to receive either Inclisiran or BPA, with treatment duration lasting approximately 150 days. A follow-up safety assessment will occur 30 days after treatment completion.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with hypercholesterolemia who are at very high or high risk for cardiovascular events and have not achieved their LDL-C target on maximally tolerated statin therapy.

Not a fit: Patients who are not on a stable high-intensity statin regimen or those with LDL-C levels below 70 mg/dL may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients struggling to lower their LDL-cholesterol levels despite existing therapies.

How similar studies have performed: Other studies have shown promising results with similar LDL-cholesterol lowering approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Fasting LDL-C ≥ 70 mg/dL at screening
2. 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
3. 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)
     * 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.
4. Fasting triglyceride \< 400 mg/dL at screening

Exclusion Criteria:

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

Where this trial is running

Konstanz, Baden Wuerttemberg and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HypercholesterolemiaLDL-cholesterolatherosclerotic cardiovascular diseaseInclisiranbempedoic acidBPAPCSK9 inhibitorhead-to-head comparison
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.