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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

10 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Inclisiran

    Inclisiran is administered via subcutaneous injection and is currently being studied in clinical trials for its effectiveness in lowering LDL cholesterol in individuals with atherosclerotic cardiovascular disease. It is an investigational medication that has shown promise in medical literature for managing hypercholesterolemia. Inclisiran works by targeting and inhibiting the production of a protein called PCSK9, which plays a role in the regulation of cholesterol levels in the blood. It is classified as a small interfering RNA (siRNA) therapeutic agent.

  • Bempedoic Acid

    Bempedoic acid is taken orally in tablet form and is approved for use in lowering LDL cholesterol levels in patients with hypercholesterolemia. It is being compared to Inclisiran in clinical trials to assess its effectiveness in combination with standard cholesterol-lowering treatments. Bempedoic acid works by inhibiting an enzyme called ATP citrate lyase, which is involved in the production of cholesterol in the liver. It is classified as a lipid-lowering agent.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511076-32-00Protocol codeCKJX839A1DE02Estimated enrolment400 patientsSponsorNovartis Pharma GmbH

sourced from the EU Clinical Trials Register and site verification

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