Study Comparing Inclisiran and Bempedoic Acid for Lowering LDL Cholesterol in Patients with Atherosclerotic Cardiovascular Disease

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What is this study about?

This clinical trial is focused on studying the effects of certain medications on people with atherosclerotic cardiovascular disease, a condition where the arteries become narrowed and hardened due to a buildup of cholesterol and other substances. The study aims to compare the effectiveness of two treatments, Inclisiran and bempedoic acid, in lowering levels of LDL cholesterol, often referred to as “bad” cholesterol, which can contribute to heart disease. Participants in the study will receive either Inclisiran, which is given as an injection, or bempedoic acid, which is taken as a tablet. Both treatments will be used alongside standard care, which may include medications like atorvastatin, rosuvastatin, and ezetimibe.

The purpose of the study is to determine if Inclisiran is more effective than bempedoic acid in reducing LDL cholesterol levels over a period of 150 days. Participants will be randomly assigned to receive one of the treatments and will be monitored throughout the study to assess changes in their cholesterol levels. The study will also look at how well participants respond to the treatments, aiming for LDL cholesterol levels to reach specific targets based on their risk of heart disease.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study is designed to provide valuable information on how these medications can help manage cholesterol levels in people with atherosclerotic cardiovascular disease, potentially leading to better treatment options in the future. A placebo may be used in some cases to compare the effects of the active treatments. The study is expected to conclude in 2025.

1 joining the study

Upon joining the study, participants are required to have a fasting LDL cholesterol level of at least 70 mg/dL.

Participants must be on a stable and well-tolerated lipid-lowering regimen for at least four weeks, which may include a high-intensity statin therapy with either atorvastatin (at least 40 mg once daily) or rosuvastatin (at least 20 mg once daily).

2 initial assessment

An initial assessment is conducted to confirm eligibility based on cardiovascular risk factors and other health criteria.

Participants are categorized as very high or high cardiovascular risk based on specific medical history and risk factors.

3 medication administration

Participants receive inclisiran sodium through subcutaneous injection.

Participants may also receive bempedoic acid, rosuvastatin, atorvastatin, and ezetimibe orally as part of their treatment regimen.

4 treatment period

The treatment period involves regular administration of the assigned medications.

Participants are monitored for changes in LDL cholesterol levels, with a primary focus on the percent change from baseline at day 150.

5 follow-up assessments

Follow-up assessments are conducted to evaluate the effectiveness of the treatment in lowering LDL cholesterol levels.

Secondary assessments include individual responsiveness and other health-related quality of life measures.

6 completion of the trial

The trial is expected to conclude by September 30, 2025.

Final assessments are conducted to determine the overall effectiveness and safety of the treatment regimen.

Who Can Join the Study?

  • Participants must have a fasting LDL-C (a type of cholesterol) level of 70 mg/dL or higher at the start of the study.
  • Participants should be on a stable and well-tolerated cholesterol-lowering treatment for at least 4 weeks. This treatment must include a high-intensity statin (a type of medication to lower cholesterol) like atorvastatin (40 mg or more daily) or rosuvastatin (20 mg or more daily), with or without Ezetimibe (10 mg).
  • Participants must be at very high or high risk for cardiovascular (CV) disease. This includes having conditions like:
    • ASCVD (Atherosclerotic Cardiovascular Disease), which includes heart-related issues like unstable angina, heart attack, or procedures to open blocked heart arteries.
    • Diabetes mellitus (DM) with damage to organs like the kidneys, eyes, or nerves, or having multiple risk factors.
    • A high calculated SCORE2 risk, which estimates the chance of heart problems over 10 years, based on age and other factors.
    • A diagnosis of heterozygous familial hypercholesterolemia (HeFH), a genetic condition causing high cholesterol, with other risk factors.
  • Participants must have a fasting triglyceride (another type of fat in the blood) level of less than 400 mg/dL at the start of the study.
  • Participants can be of any gender.
  • Participants must be within certain age ranges, typically adults.

Who Cannot Join the Study?

  • Patients who have a known allergy or sensitivity to the study medication or its ingredients.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe heart disease, which means serious problems with the heart.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is not well managed with medication.
  • Patients with liver disease, which means any condition that affects the liver’s ability to function properly.
  • Patients with kidney disease, which means any condition that affects the kidneys’ ability to function properly.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a stroke or heart attack in the past 6 months.
  • Patients with a history of cancer, unless it has been in remission for at least 5 years.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Diabetes-Zentrum-Wilhelmsburg GbR Hamburg Germany
Diabeteszentrum Hamburg West Hamburg Germany
University Hospital Jena KöR Jena Germany
University Medicine Greifswald Greifswald Germany
Universitaetsmedizin Goettingen Goettingen Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Technische Universitaet Dresden Dresden Germany
Klinik am See Rüdersdorf Germany
Klinisches Forschungszentrum Dr. Hagemann Hausarztzentrum am Germaniaplatz Essen Germany
Gemeinschaftspraxis Faghih-Friedrichs-Zühlke Essen Germany
Zentrum für klinische Studien Alexander Segner St. Ingbert Germany
Praxis für Kardiologie Markkleeberg Germany

Other Sites

Site Name City Country Status
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
FutureMeds GmbH Berlin Germany
Medizentrum Essen Borbeck Essen Germany
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Cardiologicum Hamburg GbR Hamburg Germany
B. Braun Ambulantes Herzzentrum Kassel MVZ GmbH Kassel Germany
Kardiopraxis Schirmer Kaiserslautern Germany
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH Dresden Germany
MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt Germany
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Hausarztzentrum Butendorf Gladbeck Germany
St. Vinzenz-Hospital GmbH Cologne Germany
Katholische Hospitalvereinigung Thueringen gGmbH Erfurt Germany
Siteworks GmbH Hanover Germany
ClinPhenomics CVC GmbH Frankfurt Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Klinikum Konstanz GmbH Konstanz Germany
Gemeinschaftspraxis Dr. Gerbaulet, Dr. Biesenbaum Löhne Germany
Haus der Gesundheit Ludwigshafen Am Rhein Germany
Praxis fuer Innere Medizin Munster Germany
Diabetologische Schwerpunktpraxis Pirna Pirna Germany
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Fhrvgtkasy Ghrk Offenbach Am Main Germany
Upcqywwowbcyjwopoygwv Evuef Agx Essen Germany
Msona Tsbrgd Sr Ut (svlmpcggynojetabiznr Berlin Germany
Nmwjohpunahnwni Zngxyrx Hzygasmxcbu Hoyerswerda Germany
Hgewvhyyjx Uim Mjl Glbe Ulm Germany
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Pjmpur Dox mzat Ixif Suuoawrmulga Lichtenfels Germany
Pzshrh fvn Isobkr Mstltbl / Ktauasnjvxw Dyz mqmp Aceyoyo Syftxijd Meißen Germany
Kxhpzhqc Gftbkfdwes gehna Guetersloh Germany
Gwvfmzeosausitvywvq fbh Kqztmnkxoak uju Pmhrsktmktw Berlin Germany
Ddzollqx Sougmjxjqyungxkyz Falkensee Germany
Spkdhdbiynrmaa Frs Rslsjgvb Leipzig Germany
Gnautb Ujplhksmco Fgiwbdvcy Frankfurt Germany
Djk mxag Azmjbuf Weybkv Dlu mqrq Avprbs Mcbqvkyjd ubv Dmumuon Laxns Dnbzphrj Fgipqlumpf Iikcuv Mqhdcpc ujt Kudolrztitw Pqrsmucnicfhm Papenburg Germany
Zmouoxb fhg kqwkujmpf Sparwlx Bww Hlktlqz Bad Homburg Germany
Pavset Hchfkec Mühldorf am Inn Germany
Pybmvxy Pzvnyagx &hjksrs Drt Fsizb Mfpivw Dessau-Roßlau Germany
Cbnwou Csfzrlv Gfe Bremen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
20.05.2024

Trial locations

Inclisiran is a medication used to lower LDL cholesterol levels in the blood. It works by targeting a specific protein in the liver, which helps reduce the amount of cholesterol produced by the body. This medication is being tested to see if it is more effective than other treatments in lowering cholesterol for people with cardiovascular disease.

Bempedoic Acid is another medication aimed at reducing LDL cholesterol levels. It works by inhibiting an enzyme involved in cholesterol production in the liver. This trial is comparing its effectiveness to Inclisiran in managing cholesterol levels in patients with cardiovascular conditions.

Statins are a group of medications commonly used to lower cholesterol levels. They work by blocking a substance your body needs to make cholesterol, which can help prevent heart disease and stroke. In this trial, participants are receiving the highest dose they can tolerate as part of their standard care.

Ezetimibe is a medication that helps lower cholesterol levels by reducing the amount of cholesterol absorbed by the intestines. It is often used in combination with statins to enhance cholesterol-lowering effects. In this study, it may be used alongside other treatments to help manage cholesterol levels.

Hypercholesterolemia – This condition is characterized by high levels of cholesterol in the blood, particularly low-density lipoprotein cholesterol (LDL-C), which is often referred to as “bad” cholesterol. Over time, the excess cholesterol can build up in the walls of arteries, leading to atherosclerosis, which is the narrowing and hardening of the arteries. This process can reduce or block blood flow, potentially leading to complications such as heart disease or stroke. Hypercholesterolemia can be influenced by genetic factors, diet, lifestyle, and other health conditions. It often progresses silently without symptoms until significant arterial damage occurs. Regular monitoring of cholesterol levels is important to manage and understand the progression of this condition.

Trial ID:
2024-511076-32-00
Protocol code:
CKJX839A1DE02
Trial Phase:
Therapeutic confirmatory (Phase III)

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