This clinical trial is focused on studying the effects of a treatment for hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. The study involves the use of a medication called Inclisiran, also known by its code name KJX839, which is given as an injection. Participants will also be taking Rosuvastatin, a commonly used cholesterol-lowering medication in tablet form. Some participants will receive a placebo instead of Inclisiran to compare the effects.
The purpose of the study is to determine if Inclisiran, when added to ongoing cholesterol-lowering therapy, is more effective than a placebo in helping participants reach their individual cholesterol targets. The study will also assess the safety of Inclisiran and its impact on the quality of life of participants. Participants will be randomly assigned to receive either Inclisiran or a placebo, in addition to their regular cholesterol-lowering medication, and will be monitored over a period of time to observe changes in their cholesterol levels and any side effects.
Throughout the study, participants will have regular check-ups to monitor their cholesterol levels and overall health. The study aims to provide valuable information on whether Inclisiran can offer additional benefits in managing cholesterol levels and improving the quality of life for individuals with hypercholesterolemia. The results will help determine the effectiveness and safety of Inclisiran as part of a comprehensive cholesterol-lowering treatment plan.
1joining the study
Upon joining the study, participants are required to meet specific criteria, including being 18 years or older and having a high risk of cardiovascular issues.
Participants must have been on a stable dose of a statin for at least 30 days before the study begins.
2initial assessment
An initial assessment is conducted to evaluate the participant’s health status and confirm eligibility.
This includes measuring fasting triglyceride levels, which must be below 400 mg/dL.
3medication administration
Participants receive either inclisiran or a placebo. Inclisiran is administered via subcutaneous injection.
Participants continue their ongoing lipid-lowering therapy, which includes rosuvastatin taken orally.
4monitoring and follow-up
Participants are monitored regularly to assess the effectiveness of the treatment in lowering LDL-cholesterol levels.
The primary goal is to achieve individual LDL-C targets (< 55 mg/dL or < 70 mg/dL) by day 90.
5evaluation of outcomes
The study evaluates the proportion of participants reaching their LDL-C targets and any muscle-related side effects over the course of the study.
Participants’ quality of life and any self-reported pain are also assessed until day 360.
6completion of the study
The study is expected to conclude by March 2025, with final assessments and data collection completed by this time.
Who Can Join the Study?
Participants must be male or female and at least 18 years old.
Participants should be at very high risk with at least one of the following conditions:
Documented Atherosclerotic cardiovascular disease (ASCVD), which includes:
Acute coronary syndrome, such as unstable angina or heart attack.
Stable angina, which is chest pain due to reduced blood flow to the heart.
Coronary revascularization, a procedure to restore blood flow to the heart.
ASCVD confirmed by previous imaging tests.
Stroke or Transient Ischemic Attack (TIA), a temporary period of symptoms similar to a stroke.
Peripheral artery disease (PAD), a condition where the blood vessels outside the heart are narrowed.
Diabetes mellitus (DM) with damage to target organs, such as:
Microalbuminuria, a condition where a small amount of protein is found in urine.
Retinopathy, damage to the retina of the eyes.
Neuropathy, damage to the nerves.
Or at least 3 major risk factors, or early onset of Type 1 DM lasting more than 20 years.
A calculated SCORE2 of 7.5% or higher for those under 50 years old; 10% or higher for those aged 50-69; 15% or higher for those aged 70 or older. This score estimates the 10-year risk of fatal and non-fatal cardiovascular disease.
A pre-existing diagnosis of heterozygous familial hypercholesterolemia (HeFH) with ASCVD or another major risk factor.
Participants at high risk should have at least one of the following:
Significantly high single risk factors, such as:
Total cholesterol over 310 mg/dL.
LDL-C (bad cholesterol) over 190 mg/dL.
Blood pressure of 180/110 mmHg or higher.
A pre-existing diagnosis of HeFH without other major risk factors.
Diabetes Mellitus without target organ damage, with DM lasting 10 years or more, or another additional risk factor.
Moderate chronic kidney disease, with an eGFR (a test to check kidney function) between 30-59 mL/min/1.73m².
A calculated SCORE2 between 2.5 to less than 7.5% for those under 50 years old; 5 to less than 10% for those aged 50-69; 7.5 to less than 15% for those aged 70 or older.
Participants with very high cardiovascular risk should have LDL-C levels of 55 mg/dL or higher.
Participants with high cardiovascular risk should have LDL-C levels of 70 mg/dL or higher.
Participants must be on a stable dose of a statin (a type of medication used to lower cholesterol) for at least 30 days before the screening.
Participants must be on the individual maximum tolerated dose (MTD) of statin for at least 30 days at the start of the study.
Participants must have fasting triglyceride levels below 400 mg/dL at screening and at the start of the study.
Who Cannot Join the Study?
Individuals who are not able to follow the study procedures or instructions.
People with a history of severe allergic reactions to any of the study medications.
Participants who are currently involved in another clinical trial.
Individuals with certain medical conditions that the study doctors believe could interfere with the study results.
Pregnant or breastfeeding women.
People who have had a recent heart attack or stroke.
Individuals with uncontrolled high blood pressure.
Participants with severe liver or kidney disease.
People who have been diagnosed with cancer in the past five years, except for some types of skin cancer.
Individuals who have received certain medications that might affect the study results.
Inclisiran is a medication used in this trial to help lower cholesterol levels in the blood. It works by reducing the production of a protein that affects cholesterol levels, helping to achieve the target cholesterol levels set for each participant. This medication is being tested to see if it can improve cholesterol management when added to the participant’s current cholesterol-lowering treatment.
Lipid-lowering therapy (LLT) refers to the ongoing treatment that participants are already receiving to manage their cholesterol levels. This therapy can include various medications that help reduce cholesterol in the blood, aiming to prevent heart disease and other related conditions. The trial is assessing the effectiveness of adding inclisiran to this existing treatment.
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 progress silently without symptoms until significant artery blockage occurs, potentially leading to complications such as heart disease or stroke. The progression of hypercholesterolemia is influenced by factors such as diet, lifestyle, and genetics. Regular monitoring of cholesterol levels is important to manage and understand the progression of this condition.
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