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New cholesterol drug inclisiran tested in everyday clinics

NCT ID NCT05362903

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study followed 1868 patients with high cholesterol to see how inclisiran (Leqvio®) and other cholesterol-lowering treatments work in real-world medical practice. Researchers tracked heart events, medication use, and lab results without assigning any treatments. The goal was to understand how these drugs perform outside of strict clinical trials.

What this could mean

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

Active substance
Inclisiran (Leqvio®) and other lipid-lowering treatments
What this could lead to
If successful, this study could show how well inclisiran works outside of controlled trials, helping doctors make better treatment decisions for high cholesterol.
What could go wrong
This is an observational study, not a controlled experiment, so it cannot prove cause and effect. Results may be influenced by patient selection or other factors.

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.

Participants

1,868 people

The number who actually took part.

Started

Jan 2022

Finished

Nov 2025

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.

Who is studied

* Patients with hypercholesterolemia newly initiated with oral LLT on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyramin), or new oral LLT alone in patients who are statin intolerant (Oral LLT Cohort), * Patients newly initiated with Inclisiran according to local reimbursement criteria (out of these, at least 60% naive to monoclonal antibodies targeting PCSK9) (Inclisiran Cohort) * Patients treated with Inclisiran on top of lipid apheresis from routine care (Apheresis plus Inclisiran Cohort).

Ages

18 to 100 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. Patients who provide written informed consent to participate in the study 2. Male or female patients ≥ 18 years of age 3. Oral LLT Cohort: Patients with documented ASCVD newly initiated on an oral lipid lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyraimin) or new oral LLT alone in case of statin intolerance or contraindication 4. Inclisiran Cohort: Patients newly initiated on Inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at LDL-C goal as per their CV risk as recommended in the 2019 EAS/ESC guidelines (Mach et al., 2020). At least 60% of the documented patients must be PCSK9-inhibitor naive 5. Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (LDL-c or LP(a)). Exclusion Criteria: 1. Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy 2. Inclisiran 1 Cohort: current or previous PCSK9-targeted treatment 3. Contraindication for Inclisiran according to the SmPC 4. Patients who have received Inclisiran previously 5. Patients with homozygous FH 6. Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results. 7. Simultaneous or planned participation in an interventional research study

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Conditions

The condition(s) this trial relates to.

atherosclerosis 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

    Freudenstadt, Baden-Wurttemberg, 72250, Germany

  • Novartis Investigative Site

    Heidelberg, Baden-Wurttemberg, 69115, Germany

  • Novartis Investigative Site

    Kirchheim unter Teck, Baden-Wurttemberg, 73230, Germany

  • Novartis Investigative Site

    Konstanz, Baden-Wurttemberg, 78464, Germany

  • Novartis Investigative Site

    Ulm, Baden-Wurttemberg, 89073, Germany

  • Novartis Investigative Site

    Bayreuth, Bavaria, 95445, Germany

  • Novartis Investigative Site

    Coburg, Bavaria, 96450, Germany

  • Novartis Investigative Site

    Dachau, Bavaria, 85221, Germany

  • Novartis Investigative Site

    Deggendorf, Bavaria, 94469, Germany

  • Novartis Investigative Site

    Füssen, Bavaria, 87629, Germany

  • Novartis Investigative Site

    Grünwald, Bavaria, 82031, Germany

  • Novartis Investigative Site

    Landshut, Bavaria, 84034, Germany

  • Novartis Investigative Site

    Marktoberdorf, Bavaria, 87616, Germany

  • Novartis Investigative Site

    Muehldorf Am Inn, Bavaria, 84453, Germany

  • Novartis Investigative Site

    Munich, Bavaria, 80331, Germany

  • Novartis Investigative Site

    Munich, Bavaria, 80939, Germany

  • Novartis Investigative Site

    Munich, Bavaria, 81925, Germany

  • Novartis Investigative Site

    Neumarkt in der Oberpfalz, Bavaria, 92318, Germany

  • Novartis Investigative Site

    Nuremberg, Bavaria, 90402, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Burg, Brandenburg, 03096, Germany

  • Novartis Investigative Site

    Eberswalde, Brandenburg, 16225, Germany

  • Novartis Investigative Site

    Potsdam, Brandenburg, 14473, Germany

  • Novartis Investigative Site

    Schwedt, Brandenburg, 16303, Germany

  • Novartis Investigative Site

    Kassel, Hesse, 34121, Germany

  • Novartis Investigative Site

    Offenbach, Hesse, 63065, Germany

  • Novartis Investigative Site

    Rotenburg (Wümme), Lower Saxony, 27356, Germany

  • Novartis Investigative Site

    Winsen, Lower Saxony, 21423, Germany

  • Novartis Investigative Site

    Stralsund, Mecklenburg-Vorpommern, 18435, Germany

  • Novartis Investigative Site

    Aachen, North Rhine-Westphalia, 52062, Germany

  • Novartis Investigative Site

    Detmold, North Rhine-Westphalia, 32756, Germany

  • Novartis Investigative Site

    Mülheim, North Rhine-Westphalia, 45468, Germany

  • Novartis Investigative Site

    Münster, North Rhine-Westphalia, 48143, Germany

  • Novartis Investigative Site

    Münster, North Rhine-Westphalia, 48149, Germany

  • Novartis Investigative Site

    Siegen, North Rhine-Westphalia, 57072, Germany

  • Novartis Investigative Site

    Ingelheim, Rhineland-Palatinate, 55218, Germany

  • Novartis Investigative Site

    Kaiserslautern, Rhineland-Palatinate, 67655, Germany

  • Novartis Investigative Site

    Pirmasens, Rhineland-Palatinate, 66954, Germany

  • Novartis Investigative Site

    Chemnitz, Saxony, 09113, Germany

  • Novartis Investigative Site

    Chemnitz, Saxony, 09130, Germany

  • Novartis Investigative Site

    Görlitz, Saxony, 02827, Germany

  • Novartis Investigative Site

    Hohenstein-Ernstthal, Saxony, 09337, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04158, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04317, Germany

  • Novartis Investigative Site

    Pirna, Saxony, 01796, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06108, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120, Germany

  • Novartis Investigative Site

    Quedlinburg, Saxony-Anhalt, 06484, Germany

  • Novartis Investigative Site

    Salzatal, Saxony-Anhalt, 06198, Germany

  • Novartis Investigative Site

    Wittenberg, Saxony-Anhalt, 06886, Germany

  • Novartis Investigative Site

    Greiz, Thuringia, 07973, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Altenburg, 04600, Germany

  • Novartis Investigative Site

    Aue, 08280, Germany

  • Novartis Investigative Site

    Bad Homburg, 61348, Germany

  • Novartis Investigative Site

    Bad Nauheim, 61231, Germany

  • Novartis Investigative Site

    Berlin, 10115, Germany

  • Novartis Investigative Site

    Berlin, 10789, Germany

  • Novartis Investigative Site

    Berlin, 12489, Germany

  • Novartis Investigative Site

    Berlin, 12627, Germany

  • Novartis Investigative Site

    Biedenkopf, 35216, Germany

  • Novartis Investigative Site

    Borsdorf, 04451, Germany

  • Novartis Investigative Site

    Brilon, 59929, Germany

  • Novartis Investigative Site

    Brüel, 19412, Germany

  • Novartis Investigative Site

    Chemnitz, 09116, Germany

  • Novartis Investigative Site

    Chemnitz, 09130, Germany

  • Novartis Investigative Site

    Cloppenburg, 49661, Germany

  • Novartis Investigative Site

    Cologne, 50670, Germany

  • Novartis Investigative Site

    Cologne, 51105, Germany

  • Novartis Investigative Site

    Cuxhaven, 27476, Germany

  • Novartis Investigative Site

    Dachau, 85221, Germany

  • Novartis Investigative Site

    Darmstadt, 64287, Germany

  • Novartis Investigative Site

    Dessau, 06846, Germany

  • Novartis Investigative Site

    Dresden, 01129, Germany

  • Novartis Investigative Site

    Ehingen, 89584, Germany

  • Novartis Investigative Site

    Ehringshausen, 35630, Germany

  • Novartis Investigative Site

    Eisfeld, 98673, Germany

  • Novartis Investigative Site

    Frechen, 50226, Germany

  • Novartis Investigative Site

    Fürth, 90766, Germany

  • Novartis Investigative Site

    Greifswald, 17475, Germany

  • Novartis Investigative Site

    Günzburg, 89312, Germany

  • Novartis Investigative Site

    Hamburg, 22087, Germany

  • Novartis Investigative Site

    Hamburg, 22459, Germany

  • Novartis Investigative Site

    Hamburg, 22607, Germany

  • Novartis Investigative Site

    Hamburg, 22769, Germany

  • Novartis Investigative Site

    Haßloch, 67454, Germany

  • Novartis Investigative Site

    Heide, 25746, Germany

  • Novartis Investigative Site

    Kiel, 24105, Germany

  • Novartis Investigative Site

    Ludwigshafen, 67071, Germany

  • Novartis Investigative Site

    Mainz, 55126, Germany

  • Novartis Investigative Site

    Mannheim, 68165, Germany

  • Novartis Investigative Site

    Markkleeberg, 04416, Germany

  • Novartis Investigative Site

    Moers, 47441, Germany

  • Novartis Investigative Site

    München, 80333, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Naumburg, 06618, Germany

  • Novartis Investigative Site

    Neuruppin, 16816, Germany

  • Novartis Investigative Site

    Olpe, 57462, Germany

  • Novartis Investigative Site

    Oranienburg, 16515, Germany

  • Novartis Investigative Site

    Oschatz, 04758, Germany

  • Novartis Investigative Site

    Osnabrück, 49080, Germany

  • Novartis Investigative Site

    Osnabrück, 49088, Germany

  • Novartis Investigative Site

    Papenburg, 26871, Germany

  • Novartis Investigative Site

    Rendsburg, 24768, Germany

  • Novartis Investigative Site

    Riesa, 01589, Germany

  • Novartis Investigative Site

    Rostock, 18107, Germany

  • Novartis Investigative Site

    Schwandorf in Bayern, 92421, Germany

  • Novartis Investigative Site

    Speyer, 67346, Germany

  • Novartis Investigative Site

    Stadtlohn, 48703, Germany

  • Novartis Investigative Site

    Trier, 54292, Germany

  • Novartis Investigative Site

    Ulm, 89073, Germany

  • Novartis Investigative Site

    Ulm, 89077, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Wermsdorf, 04779, Germany

  • Novartis Investigative Site

    Wesel, 46485, Germany

  • Novartis Investigative Site

    Winterberg, 59955, Germany

  • Novartis Investigative Site

    Wismar, 23966, Germany

  • Novartis Investigative Site

    Wuppertal, 42289, Germany

  • Novartis Investigative Site

    Würzburg, 97070, Germany

  • Novartis Investigative Site

    Zwiesel, 94227, Germany

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