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Ongoing Clinical Trials for Hypercholesterolaemia

This article presents information on 10 ongoing clinical trials for hypercholesterolaemia (also known as: high cholesterol, elevated cholesterol, dyslipidemia). These trials are testing various medications including MK-0616, inclisiran, evolocumab, bempedoic acid, and ezetimibe across multiple European countries. The studies focus on lowering LDL cholesterol levels in patients with high cardiovascular risk and those who have experienced cardiovascular events.

Clinical trial locations

Study of AZD0780 in patients with high cholesterol and heart disease or risk of heart disease to lower bad cholesterol levels

This trial is testing AZD0780 (laroprovstat) in patients who have high levels of LDL cholesterol despite taking standard cholesterol-lowering medications. The study focuses on people with atherosclerotic cardiovascular disease or those at risk of developing heart disease.

Who can participate: Adults aged 18 and older with a history of heart and blood vessel disease or risk factors such as diabetes, high blood pressure, smoking, kidney disease, or obesity are eligible. Participants must have LDL cholesterol levels of at least 55 mg/dL if they have existing heart disease, or at least 70 mg/dL if they are at risk. They must be taking stable doses of statins for at least 28 days.

Who cannot participate: People with severe allergic reactions to medications, pregnant or breastfeeding women, those with severe liver or kidney problems, uncontrolled high blood pressure, recent heart attack or stroke within 6 months, active cancer, history of muscle problems from cholesterol medications, uncontrolled diabetes, or substance abuse within the past year are excluded.

What the study involves: The trial aims to determine how effectively AZD0780 lowers LDL cholesterol levels after 12 weeks of treatment compared to placebo. Participants will take film-coated tablets daily while continuing their regular cholesterol medications. The study will monitor cholesterol levels at 12, 28, and 52 weeks, measuring LDL cholesterol, apolipoprotein B, and other blood fats. The trial will last 52 weeks and is being conducted across multiple European countries including Czechia, Germany, Poland, Slovakia, Hungary, Bulgaria, and Spain.

Study medication: AZD0780 is an investigational medication designed to lower LDL cholesterol levels in patients with existing cardiovascular disease or those at risk of developing heart problems. It is administered orally as a film-coated tablet.

Study on Evolocumab for Reducing Cardiovascular Events in Patients with Acute Myocardial Infarction

This trial is evaluating evolocumab (also known as AMG145) in patients hospitalized for a heart attack. The study aims to determine whether adding evolocumab to standard cholesterol management can reduce the risk of future heart attacks, strokes, or the need for procedures to restore blood flow in arteries.

Who can participate: Patients must be at least 18 years old and currently hospitalized for a heart attack, either NSTEMI or STEMI, caused by atherosclerotic disease. Participants must provide informed consent or have a legally authorized representative provide consent on their behalf.

Who cannot participate: The trial excludes patients with a history of severe allergic reactions to the study medication, current or recent infections, cancer within the past 5 years (except certain skin cancers), severe liver or kidney disease, pregnant or breastfeeding women, those participating in another clinical trial simultaneously, or anyone with other medical conditions deemed unsafe by study doctors.

What the study involves: Participants will receive either evolocumab or placebo in addition to their regular cholesterol management. Evolocumab is administered through a subcutaneous injection using an autoinjector pen. The study will monitor participants over time for cardiovascular events including heart attacks, strokes, procedures to restore blood flow, and deaths from any cause. A subset of approximately 300 participants will have their LDL cholesterol levels measured at 12 and 52 weeks. The trial is expected to conclude by December 31, 2027, and is being conducted in Sweden.

Study medication: Evolocumab is given through injection and works alongside routine cholesterol management to help reduce the risk of further heart-related issues.

Study on the Effect of Genetic Testing and Training on Muscle Side Effects in Patients Taking Statins for Cardiovascular Risk Prevention

This trial examines whether genetic testing can help reduce muscle-related side effects in patients taking statins for cardiovascular risk management. The study compares two approaches: prescribing statins based on standard medical practice versus using genetic testing results to guide treatment decisions.

Who can participate: Adults with any level of cardiovascular risk who require statin treatment at any dose are eligible. Participants must be outpatients recruited from healthcare centers or hospitals who have never taken statins before, started treatment less than 15 days ago, or had their statin dose increased or changed within the last 15 days due to poor cholesterol control. Both males and females can participate, and participants must be willing to provide written informed consent.

Who cannot participate: Patients outside the specified age range or those belonging to vulnerable populations requiring special protection or care are excluded.

What the study involves: Participants will take one of several statins orally, including pravastatin sodium, atorvastatin, pitavastatin calcium, fluvastatin sodium, or rosuvastatin zinc. Genetic testing may be conducted to identify specific genetic markers (SLCO1B1, ABCG2, CYP2C9) that influence response to statin treatment. The study follows participants for six months to monitor for muscle-related side effects, with some participants being followed for up to a year or longer. The trial is being conducted in Spain.

Study medications: Various statins are being studied to determine how genetic information can help doctors choose the most appropriate statin for each patient to minimize muscle-related side effects.

Study on the Effects and Safety of MK-0616 for Adults with High Cholesterol

This trial evaluates the effectiveness and safety of MK-0616, a new cholesterol-lowering medication provided as a film-coated tablet. The study aims to determine how well MK-0616 can lower cholesterol levels in adults with hypercholesterolaemia.

Who can participate: Adults with a history of cardiovascular events or at intermediate to high risk must have LDL cholesterol levels of 55 mg/dL or higher (with cardiovascular history) or 70 mg/dL or higher (without such history). At screening, participants must be treated with moderate or high-intensity statins with or without other therapies, on low-intensity statins with documented intolerance to higher doses, or not receiving statins with proof of intolerance to at least two different statins. Those on cholesterol-lowering therapies must be on stable doses for at least 30 days.

Who cannot participate: Specific exclusion criteria were not fully detailed in the source data, but typically include people with severe medical conditions that might interfere with the study, recent surgeries, allergic reactions to similar medications, pregnant or breastfeeding women, severe liver or kidney problems, inability to follow study procedures, history of substance abuse, or current participation in another clinical trial.

What the study involves: Participants will be randomly assigned to receive either MK-0616 or placebo for 52 weeks. The primary focus is on measuring changes in LDL cholesterol levels at Week 24 and Week 52. Regular check-ups will monitor cholesterol levels and any side effects. The study is being conducted in Spain, Germany, and Italy.

Study medication: MK-0616 is an oral medication in tablet form designed to lower LDL cholesterol levels and reduce the risk of heart disease.

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

This trial compares two treatments, inclisiran and bempedoic acid, to determine which is more effective in lowering LDL cholesterol levels in patients with atherosclerotic cardiovascular disease, where arteries become narrowed and hardened.

Who can participate: Participants must have fasting LDL cholesterol levels of at least 70 mg/dL and be on stable, well-tolerated cholesterol-lowering treatment for at least four weeks, including high-intensity statins such as atorvastatin (at least 40 mg daily) or rosuvastatin (at least 20 mg daily), with or without ezetimibe. Participants must be at very high or high cardiovascular risk based on conditions such as atherosclerotic cardiovascular disease, diabetes with organ damage, high SCORE2 risk, or heterozygous familial hypercholesterolaemia with other risk factors. Fasting triglyceride levels must be less than 400 mg/dL.

Who cannot participate: Patients with known allergies to study medications, currently participating in another clinical trial, severe heart disease, uncontrolled high blood pressure, liver or kidney disease, pregnant or breastfeeding women, stroke or heart attack in the past 6 months, history of cancer (unless in remission for at least 5 years), or other medical conditions deemed unsafe by study doctors are excluded.

What the study involves: Participants will receive either inclisiran (given as an injection) or bempedoic acid (taken as a tablet) alongside standard care including atorvastatin, rosuvastatin, and possibly ezetimibe. The study will monitor cholesterol levels over 150 days to assess which treatment is more effective in reducing LDL cholesterol. The trial is expected to conclude in September 2025 and is being conducted in Germany.

Study medications: Inclisiran targets a specific protein in the liver to reduce cholesterol production, while bempedoic acid inhibits an enzyme involved in cholesterol production. Both aim to lower LDL cholesterol levels more effectively than standard treatments alone.

Study of Bempedoic Acid for Children Aged 6-17 with Familial Hypercholesterolemia

This trial studies bempedoic acid (also known as ETC-1002) in children and teenagers aged 6 to 17 with heterozygous familial hypercholesterolaemia, a genetic disorder causing high cholesterol levels. The medication is available as a film-coated tablet or oral suspension.

Who can participate: Children between 6 and 17 years old weighing at least 16 kilograms with a diagnosis of heterozygous familial hypercholesterolaemia confirmed by genetic testing or specific cholesterol levels and family history are eligible. Participants must be taking approved cholesterol-lowering medications at stable doses for at least 4 weeks (6 weeks for fibrates, though gemfibrozil is not allowed with statins) and have fasting LDL cholesterol levels of at least 130 mg/dL. Female participants must not be pregnant, planning to become pregnant, or breastfeeding, and must agree to use birth control if sexually active. Parent or guardian consent and child assent are required.

Who cannot participate: Children outside the 6-17 age range, those without heterozygous familial hypercholesterolaemia, or those from vulnerable populations are excluded.

What the study involves: Participants will take bempedoic acid orally once daily for 8 weeks. The study will monitor how the body processes the medication and its effects on cholesterol levels, including LDL cholesterol and other markers. Researchers will also assess tolerability, including taste and ease of swallowing. The study is expected to continue until 2025 and is being conducted in Spain, Germany, Denmark, and the Netherlands.

Study medication: Bempedoic acid works by inhibiting ATP citrate lyase, an enzyme involved in cholesterol synthesis in the liver, thereby lowering cholesterol levels.

Study on Inclisiran and Rosuvastatin for Lowering Cholesterol in Patients with High Cholesterol Levels

This trial investigates whether inclisiran (also known as KJX839), when added to ongoing cholesterol-lowering therapy, is more effective than placebo in helping participants reach their individual cholesterol targets. The study also assesses the safety of inclisiran and its impact on quality of life.

Who can participate: Males and females at least 18 years old who are at very high or high cardiovascular risk are eligible. Very high risk includes documented atherosclerotic cardiovascular disease, diabetes with organ damage or multiple risk factors, calculated SCORE2 of 7.5% or higher (varying by age), or heterozygous familial hypercholesterolaemia with atherosclerotic cardiovascular disease or another major risk factor. High risk includes significantly elevated single risk factors, heterozygous familial hypercholesterolaemia without other major risk factors, diabetes lasting 10+ years with additional risk factors, moderate chronic kidney disease, or calculated SCORE2 between specified ranges. Participants must have LDL cholesterol of 55 mg/dL or higher (very high risk) or 70 mg/dL or higher (high risk) and be on stable statin doses at maximum tolerated levels for at least 30 days. Fasting triglycerides must be below 400 mg/dL.

Who cannot participate: People unable to follow study procedures, those with severe allergies to study medications, current participants in other trials, individuals with interfering medical conditions, pregnant or breastfeeding women, recent heart attack or stroke, uncontrolled high blood pressure, severe liver or kidney disease, cancer in the past five years (except some skin cancers), or recent use of medications affecting study results are excluded.

What the study involves: Participants receive either inclisiran or placebo via subcutaneous injection while continuing their ongoing cholesterol therapy, including rosuvastatin taken orally. Regular monitoring assesses effectiveness in lowering LDL cholesterol levels, with the primary goal of achieving individual targets (less than 55 mg/dL or less than 70 mg/dL) by day 90. The study also evaluates muscle-related side effects, quality of life, and self-reported pain until day 360. The trial is expected to conclude by March 2025 and is being conducted in Czechia, Germany, Poland, Latvia, Spain, Bulgaria, Estonia, and France.

Study medication: Inclisiran works by inhibiting PCSK9 protein production, resulting in increased clearance of LDL cholesterol from the bloodstream. It represents a novel small interfering RNA approach to cholesterol management.

Study on MK-0616, Ezetimibe, and Bempedoic Acid for Adults with High Cholesterol

This trial evaluates the effectiveness and safety of MK-0616 compared to ezetimibe, bempedoic acid, and a combination of ezetimibe and bempedoic acid. The study aims to determine which treatment is most effective in reducing cholesterol levels over 56 days.

Who can participate: Participants must have a history of major atherosclerotic cardiovascular disease events or be at intermediate to high risk of a first major event. If they have such history, fasting LDL cholesterol should be 55 mg/dL or higher; without such history, it should be 70 mg/dL or higher. Participants must be treated with low, moderate, or high-intensity statins with or without other cholesterol-lowering therapies, on stable doses with no planned changes during the study. Participants must be at least 18 years old.

Who cannot participate: Individuals with severe allergic reactions to study medications, severe liver disease, uncontrolled high blood pressure, heart attack or stroke in the last 3 months, kidney problems requiring dialysis, pregnant or breastfeeding women, those taking interfering medications, history of substance abuse in the past year, participation in another trial in the last 30 days, or inability to follow study procedures are excluded.

What the study involves: Participants are randomly assigned to receive MK-0616, ezetimibe, bempedoic acid, or a combination of ezetimibe and bempedoic acid, or placebo. All medications are taken orally as film-coated tablets. The study is double-blind, meaning neither participants nor researchers know which treatment each participant receives. Regular monitoring measures the change in LDL cholesterol levels from baseline to Day 56, along with other cholesterol-related markers and any adverse events. The study is estimated to conclude by September 2025 and is being conducted in Spain and France.

Study medications: MK-0616 targets specific pathways to reduce LDL cholesterol. Ezetimibe reduces cholesterol absorption in the intestines. Bempedoic acid inhibits ATP-citrate lyase, reducing cholesterol production in the liver.

Study on the Effectiveness and Safety of MK-0616 for Adults with High Cholesterol

This trial evaluates MK-0616, a film-coated tablet containing enlicitide chloride, to assess its effectiveness and safety in reducing cholesterol levels compared to placebo in adults with hypercholesterolaemia.

Who can participate: Adults at least 18 years old with hypercholesterolaemia are eligible. Participants must have a history of major atherosclerotic cardiovascular disease events or be at intermediate to high risk of a first major event. If they have such history, LDL cholesterol should be 55 mg/dL or higher; without such history, 70 mg/dL or higher. At screening, participants must be treated with moderate or high-intensity statins with or without other therapies, on low-intensity statins with documented intolerance to higher doses, or not receiving statins with proof of intolerance to at least two different statins. Those on cholesterol-lowering therapies must be on stable doses for at least 30 days with no planned changes during the study.

Who cannot participate: Patients outside the specified age range or those belonging to vulnerable populations are excluded.

What the study involves: Participants are randomly assigned to receive either MK-0616 or placebo for 52 weeks. The main focus is on changes in LDL cholesterol levels at Week 24. Regular check-ups monitor cholesterol levels and overall health, including any side effects experienced. The study is being conducted in Spain, Germany, and Italy.

Study medication: MK-0616 works by inhibiting a specific enzyme involved in cholesterol production, thereby reducing overall cholesterol levels in the body and potentially reducing cardiovascular disease risk.

Study on the Safety and Efficacy of MK-0616 for Adults with High Cholesterol

This open-label extension trial evaluates the long-term safety and tolerability of MK-0616 in adults who have already completed a previous MK-0616 trial. The study monitors participants for several years to gather comprehensive data on the medication’s long-term effects.

Who can participate: Participants must have completed a previous MK-0616 study with at least 80% compliance, including finishing all required tests and procedures. Participants can be of any gender and must be adults or older adults, but should not belong to vulnerable populations.

Who cannot participate: People with certain medical conditions incompatible with the study, those outside the specified age range, individuals from vulnerable populations, those not meeting specific health requirements, people taking interfering medications or treatments, individuals with certain medical histories affecting study results, pregnant or breastfeeding women, recent participants in other clinical trials, those unable to follow study procedures, or anyone with allergies to the study medication are excluded.

What the study involves: Participants continue taking MK-0616 tablets orally. The study is open-label, meaning both participants and researchers know the treatment being administered. Regular monitoring tracks any adverse events and measures changes in LDL cholesterol and other markers from the parent study baseline at Week 8. The percentage of participants achieving specific LDL cholesterol reduction targets is also evaluated. The study is expected to end on October 13, 2028, with recruitment starting October 24, 2024. The trial is being conducted in Spain, Germany, France, Italy, Finland, Netherlands, Czechia, Norway, and Hungary.

Study medication: MK-0616 is a film-coated tablet containing enlicitide chloride, designed to lower cholesterol levels by inhibiting an enzyme involved in cholesterol production.

Summary

These 10 clinical trials represent a diverse array of approaches to managing hypercholesterolaemia across Europe. The studies are distributed across multiple countries, with Spain and Germany hosting the highest number of trials. Several trials focus on novel medications such as MK-0616, which appears in multiple studies evaluating its effectiveness and safety in various populations and durations. Inclisiran and bempedoic acid also feature prominently, with trials comparing these medications to each other and to standard treatments.

A notable aspect of these trials is their focus on high-risk populations, particularly patients with atherosclerotic cardiovascular disease or those who have experienced cardiovascular events. Several studies specifically target patients who have difficulty tolerating high-dose statins or have not achieved adequate cholesterol control with current therapies. One trial uniquely focuses on pediatric patients aged 6-17 with familial hypercholesterolaemia, addressing an often underserved population. Another innovative study examines whether genetic testing can help personalize statin therapy to reduce muscle-related side effects.

The primary outcome across most trials is the reduction in LDL cholesterol levels, with measurements typically taken between 12 and 56 weeks. Many trials also assess secondary outcomes including other cholesterol markers, quality of life, and safety profiles. These studies collectively aim to expand treatment options for patients with hypercholesterolaemia and improve cardiovascular risk management across diverse patient populations.

Ongoing Clinical Trials on Hypercholesterolaemia

  • Study on the Effect of Genetic Testing and Training on Muscle Side Effects in Patients Taking Statins for Cardiovascular Risk Prevention

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