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

3 1 1 1

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

Other Sites

Site Name City Country Status
St. Vinzenz-Hospital GmbH Cologne Germany
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt Germany
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Cfofxua Uxgvykcwfpvqckcngrdq Bfghag Kcp Berlin Germany
Uctsskgayzfaevwlobmrk Hdtwixappm Aop Heidelberg Germany
Mbrtegt Cpvzvb &kdybnw Uonjdplnxi Oq Fxwaklwu Freiburg Im Breisgau Germany
Urzfjutbmavtsonemcffs Eixnm Azp Essen Germany
Urdgycsuunnpvaphqikzg Aqvukk Avw Aachen Germany
Ustohbfawlkdrcfdpmwnj Szuqqtfntqrlofgecp Amu Kiel Germany
Penatut Pahjrnzj &lqlrfk Dqb Fahsr Myupnk Dessau-Roßlau Germany
Mswln Tyuneb Sh Uu (pwywylrkyfkmbhisdygd Berlin Germany
Nmrpfiyakrzyrby Zeqspwa Hzqmshocjcs Hoyerswerda Germany
Hxwwltcruy Uer Mhm Gztu Ulm Germany
Veentnwe Grhc Amberg Germany
Mng Pycqeq Brdpdxuqxqt Grup Papenburg Germany
Hjji dyv Gaqqejubbr Ludwigshafen Am Rhein Germany
Kyafrelzraprqv Ghihbeqrwauwpefxlsg Aj Pinl Ssosojjqv Potsdam Germany
Gtmkgjhdvuhtmmwqraw Dey Gbytewaqhk Dmz Bdoinoyael Löhne Germany
Pkeubf fvje Ifdyew Mnvxxgh Munster Germany
Pnursj Dzn mrnr Ijmv Scbykilrglpm Lichtenfels Germany
Phjiaw fqt Iibwbp Mziknyi / Kmipnhiuxvw Dzg mfty Abbqasy Sfecpzge Meißen Germany
Khctmgas Gpzaqfvnpw gtmuf Guetersloh Germany
Pvfbvc Hcpesji Mühldorf am Inn Germany
Gjattunrtubqdogbxql fob Kwyhwsgemtq uqf Pdhmzhuyfas Berlin Germany
Cczegpfmrlobf Cdj Gtnb Frankfurt Germany
Dkurzitg Shqgjauicybuzasos Falkensee Germany
Srrleaylzxlsms Fqy Rnzegocu Leipzig Germany
Fgnhzmlrdp Gmio Offenbach Am Main Germany
Utyuipfunxhgrezrlpogu Rbcdyvzqar Agh Regensburg Germany
Seavhhods Glpy Hanover Germany
Gghtdu Uprojiuzar Fbuaggjzh Frankfurt Germany
Dge mtxy Akvzdvb Wpogwa Ddk mqni Aswrrm Msxqeddty usb Dtrghuq Lwyve Dpwxjovw Fsledisodj Imzavc Mkimxvf uvi Kaxqktopzxi Pvucfzeotmlgv Papenburg Germany
Seh Elzsmqdec Gbvphh Gijd Kfomyepbptz Khtgibom Riexmyldqe Herne Germany
Kixwzmio Kkshmfwl Gzsw Konstanz Germany
Rbcsqr Bwhcv Gxhfcljtdgna fffo mzbqhxuhfzvi Fetebpfsj mjn Stuttgart Germany
Hlnk Utp Dzptoomhqcucvks Nfx Biw Opkbbcvscq Unwqrdzvfzqyfozoytu Ddx Rvedmdrgnsajzxdsd Bpxxkr Bad Oeynhausen Germany
Kzbabjyuxso Hociahtikwqyeazvwdf Tnybyiaphu gjcpi Erfurt Germany
Fnlrmzpprq Getx Berlin Germany
Mwoesnpxgiy Efqjs Byxlmle Essen Germany
Cngvkbiujlfti Hdrckjf Ggj Hamburg Germany
Bc Bsiox Aaxxplosyc Hobfhkfcrma Kykjan Mxr Gvvx Kassel Germany
Kwnmorjrocud Swzfwmna Kaiserslautern Germany
Foxagajlaresbaz Dvzbbwivrqocfmdi Bmcrbdzbbrcvjfcujxhb mtg Dresden Germany
Hyaazorcaouobkp Bzyxxbhdo Gladbeck Germany
Zekieht ffh kpqulfxhy Sszhppo Bsn Hxhhjzf Bad Homburg Germany
Dhlwaelvshqbqlq Sqznlesntmkfdzkek Pfwpc Pirna Germany
Crhfog Cxbxggd Gga 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.

Investigated Diseases:

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)

Other Trials to Consider

  • Triple vs dual therapy with rosuvastatin, ezetimibe and bempedoic acid in patients with atherosclerotic heart disease and high cholesterol undergoing revascularisation

    Recruiting

    3 1 1 1
    Austria Germany
  • Study of K-924 (ezetimibe and pitavastatin) in patients with high cholesterol who have an inadequate response to pitavastatin

    Recruiting

    3 1 1
    Investigated Diseases:
    Investigated Drugs:
    Spain