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New injection challenges pill in battle against high cholesterol

NCT ID NCT06431763

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tested whether a twice-yearly injection (inclisiran) lowers LDL cholesterol better than a daily pill (bempedoic acid) in 402 adults with heart disease who still have high cholesterol despite taking statins. Participants received either inclisiran or bempedoic acid on top of their usual statin therapy. The main goal was to see which drug reduces LDL cholesterol more after 150 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inclisiran (a long-acting injection) and bempedoic acid (a daily pill)
What this could lead to
If inclisiran works better, it could become a preferred option for lowering cholesterol in people with heart disease who still have high levels despite statins.
What could go wrong
This is a completed Phase 4 trial, so results are available but may not show a clear advantage. Also, inclisiran requires injections, which some may find less convenient than a pill.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

402 people

The number who actually took part.

Started

Jun 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypercholesterolemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305, Germany

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70376, Germany

  • Novartis Investigative Site

    Lichtenfels, Bavaria, 96215, Germany

  • Novartis Investigative Site

    Muehldorf Am Inn, Bavaria, 84453, Germany

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    Sulzbach-Rosenberg, Bavaria, 92237, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60389, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60594, Germany

  • Novartis Investigative Site

    Offenbach, Hesse, 63065, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50733, Germany

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45355, Germany

  • Novartis Investigative Site

    Löhne, North Rhine-Westphalia, 32584, Germany

  • Novartis Investigative Site

    Kaiserslautern, Rhineland-Palatinate, 67655, Germany

  • Novartis Investigative Site

    Saint Ingbert, Saarland, 66386, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01099, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04209, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Aachen, 52074, Germany

  • Novartis Investigative Site

    Bad Homburg, 61348, Germany

  • Novartis Investigative Site

    Bad Krozingen, 79189, Germany

  • Novartis Investigative Site

    Bad Oeynhausen, 32545, Germany

  • Novartis Investigative Site

    Bamberg, 96049, Germany

  • Novartis Investigative Site

    Berlin, 10367, Germany

  • Novartis Investigative Site

    Berlin, 13347, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Bochum, 44789, Germany

  • Novartis Investigative Site

    Bochum, 44791, Germany

  • Novartis Investigative Site

    Bremen, 28277, Germany

  • Novartis Investigative Site

    Dessau, 06846, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Erfurt, 99097, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Essen, 45355, Germany

  • Novartis Investigative Site

    Falkensee, 14612, Germany

  • Novartis Investigative Site

    Gladbeck, 45968, Germany

  • Novartis Investigative Site

    Hamburg, 21109, Germany

  • Novartis Investigative Site

    Hamburg, 22041, Germany

  • Novartis Investigative Site

    Hamburg, 22607, Germany

  • Novartis Investigative Site

    Hoyerswerda, 02977, Germany

  • Novartis Investigative Site

    Kassel, 34121, Germany

  • Novartis Investigative Site

    Kiel, 24105, Germany

  • Novartis Investigative Site

    Ludwigshafen, 67067, Germany

  • Novartis Investigative Site

    Magdeburg, 39120, Germany

  • Novartis Investigative Site

    Markkleeberg, 04416, Germany

  • Novartis Investigative Site

    Meissen, 01662, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Papenburg, 26871, Germany

  • Novartis Investigative Site

    Pirna, 01796, Germany

  • Novartis Investigative Site

    Potsdam, 14471, Germany

  • Novartis Investigative Site

    Rüdersdorf, 15562, Germany

  • Novartis Investigative Site

    Ulm, 89077, Germany

  • Novartis Investigative Site

    Völklingen, 66333, Germany

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