Type IIa hyperlipidaemia – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Wed, 24 Jun 2026 04:15:14 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Type IIa hyperlipidaemia – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Atorvastatin, Placebo, and No Treatment in Adults with Familial Hypercholesterolaemia and Statin-Associated Muscle Symptoms https://clinicaltrials.eu/trial/atorvastatin-placebo-and-no-treatment-in-adults-with-familial-hypercholesterolaemia-and-statin-associated-muscle-symptoms/ Tue, 02 Jun 2026 09:56:41 +0000 https://clinicaltrials.eu/trial/atorvastatin-placebo-and-no-treatment-in-adults-with-familial-hypercholesterolaemia-and-statin-associated-muscle-symptoms/ This study is being done in adults with familial hypercholesterolaemia, a condition that causes very high levels of cholesterol in the blood. It is looking at atorvastatin, a medicine used to lower cholesterol, and placebo. The purpose of the study is to find out whether muscle symptoms are truly caused by atorvastatin or whether they are linked to other reasons.

The study uses a step-by-step treatment plan. Each person will have periods with atorvastatin, periods with placebo, and a period with no study treatment. The order of these periods is arranged by chance. During the study, muscle symptoms are checked over time to compare how they change during each period.

The study is designed to help understand statin-associated muscle symptoms, which are muscle problems that some people notice while taking statin medicines such as atorvastatin. It also looks at whether some symptoms may be nocebo or misattributed, meaning they are felt as real symptoms but may not be caused by the medicine itself.

]]> Lerodalcibep for Heterozygous Familial Hypercholesterolemia in Children and Adolescents 6 to 17 Years Old https://clinicaltrials.eu/trial/lerodalcibep-for-children-and-adolescents-with-heterozygous-familial-hypercholesterolemia/ Tue, 02 Jun 2026 09:56:37 +0000 https://clinicaltrials.eu/trial/lerodalcibep-for-children-and-adolescents-with-heterozygous-familial-hypercholesterolemia/ This study is being done in children and adolescents with Heterozygous Familial Hypercholesterolemia, a condition passed down in families that causes very high cholesterol levels from a young age. The study is testing lerodalcibep, a medicine given as a monthly injection under the skin, to see whether it can lower LDL-C, often called “bad cholesterol,” more than placebo when used together with a stable diet and oral cholesterol-lowering medicine.

The study lasts about 24 weeks. Participants are assigned by chance to receive either lerodalcibep or placebo, and neither the family nor the study team knows which one is given during the study. The medicine is given once a month, and study visits are spread over the treatment period. Doctors also check general health, growth, and development, and watch for side effects and other safety concerns.

The main purpose of the study is to find out whether lerodalcibep is safe and effective for lowering LDL-C in children and adolescents with this inherited cholesterol disorder. Other blood fats and some body changes related to growth and hormones are also followed during the study.

]]> Study on MK-0616 for Reducing Heart Disease Events in Patients with Atherosclerotic Cardiovascular Disease https://clinicaltrials.eu/trial/study-on-mk-0616-for-reducing-heart-disease-events-in-patients-with-atherosclerotic-cardiovascular-disease/ Mon, 04 May 2026 07:51:42 +0000 https://clinicaltrials.eu/trial/study-on-mk-0616-for-reducing-heart-disease-events-in-patients-with-atherosclerotic-cardiovascular-disease/ This clinical trial is focused on studying a condition known as Atherosclerotic Cardiovascular Disease (ASCVD). This disease involves the buildup of fatty deposits in the arteries, which can lead to serious heart problems. The study is testing a new treatment called MK-0616, which is a film-coated tablet developed by Merck & Co. Inc. The purpose of the study is to evaluate how effective and safe MK-0616 is in reducing major heart-related events in people who are at high risk for cardiovascular issues.

Participants in the study will be randomly assigned to receive either the MK-0616 tablet or a placebo, which looks like the real medication but does not contain the active ingredient. The study will monitor participants over a period to see if MK-0616 can help delay or prevent serious events such as heart attacks, strokes, or other cardiovascular complications. The study aims to understand if MK-0616 can increase the time before a participant experiences a major heart-related event.

Throughout the study, participants will continue their usual care and medications, and their health will be closely monitored by the research team. The study will also look at changes in cholesterol levels and other markers that are important for heart health. The goal is to gather information that could lead to better treatments for people with high cardiovascular risk due to ASCVD.

]]> A Study of Enlicitide for Safety and Effectiveness in Children and Adolescents with Heterozygous Familial Hypercholesterolemia https://clinicaltrials.eu/trial/a-study-of-enlicitide-for-safety-and-effectiveness-in-children-and-adolescents-with-heterozygous-familial-hypercholesterolemia/ Wed, 29 Apr 2026 15:08:43 +0000 https://clinicaltrials.eu/trial/a-study-of-enlicitide-for-safety-and-effectiveness-in-children-and-adolescents-with-heterozygous-familial-hypercholesterolemia/ This study is looking at heterozygous familial hypercholesterolemia in children, which is an inherited condition that causes high cholesterol levels from a young age. The study will test a medication called enlicitide, which has the code name MK-0616, given as a film-coated tablet that is taken by mouth. Some participants will receive placebo instead of the actual medication for comparison. The purpose of this study is to see how well enlicitide works in lowering cholesterol levels in children with this condition, to understand how the medication moves through the body in different age groups, and to check its safety when used in pediatric patients.

The study is divided into different parts. Part A will look at how the medication is processed in the body in two age groups: children aged 12 to under 18 years and children aged 6 to under 12 years. Part B will compare the effects of enlicitide to placebo over 24 weeks, measuring changes in low-density lipoprotein cholesterol, which is a type of harmful cholesterol often called bad cholesterol. The study will also measure other cholesterol-related substances in the blood, including apolipoprotein B, non-high-density lipoprotein cholesterol, and lipoprotein (a). Additionally, the study will use ultrasound to check for changes in the thickness of blood vessel walls. Children participating in the study will continue taking their current cholesterol-lowering medications at stable doses throughout the study.

After completing either Part A or Part B, participants may have the option to continue in an open-label extension period, where they will receive the active medication. Throughout all parts of the study, doctors will closely monitor participants for any side effects or unwanted reactions to the treatment. The study will track how many participants experience any health problems and whether any participants need to stop taking the medication because of side effects. The maximum daily dose of enlicitide used in this study will be 20 milligrams, and participants may receive treatment for up to 180 weeks depending on which part of the study they join.

]]> A study testing how well zodasiran works and how safe it is for teenagers and adults with homozygous familial hypercholesterolemia https://clinicaltrials.eu/trial/a-study-testing-how-well-zodasiran-works-and-how-safe-it-is-for-teenagers-and-adults-with-homozygous-familial-hypercholesterolemia/ Wed, 29 Apr 2026 15:07:58 +0000 https://clinicaltrials.eu/trial/a-study-testing-how-well-zodasiran-works-and-how-safe-it-is-for-teenagers-and-adults-with-homozygous-familial-hypercholesterolemia/ This study examines Homozygous Familial Hypercholesterolemia, a rare inherited condition where the body cannot properly remove cholesterol from the blood, leading to extremely high cholesterol levels from birth. People with this condition have a much higher risk of heart disease at a young age. The study will test a medication called zodasiran, which is also known by its code name ARO-ANG3. This medication works by targeting a specific protein in the body that affects cholesterol levels. Some participants will receive zodasiran while others will receive placebo. All participants will continue taking their regular cholesterol-lowering medications during the study.

The main goal of this study is to find out if zodasiran can reduce low-density lipoprotein cholesterol, commonly called bad cholesterol, compared to placebo in people with this genetic condition. The study will measure cholesterol levels in the blood after participants have not eaten, which is called fasting cholesterol. The researchers will look at various types of fats in the blood, including different forms of cholesterol and other substances that carry fats through the bloodstream.

The study will last approximately 12 months for the main treatment period. Participants will receive the study medication as an injection under the skin using a pre-filled syringe. The maximum dose that may be given is 200 milligrams at one time, with a total maximum dose of 2000 milligrams over the entire treatment period of 24 weeks. During the study, doctors will regularly check cholesterol levels and other measurements to see how well the treatment is working and to monitor for any side effects. The study includes both teenagers aged 12 years and older as well as adults who have been diagnosed with this inherited cholesterol condition.

]]> Study of laroprovstat (AZD0780) tablets to lower cholesterol levels in adults with inherited high cholesterol condition (heterozygous familial hypercholesterolemia) https://clinicaltrials.eu/trial/study-of-laroprovstat-azd0780-tablets-to-lower-cholesterol-levels-in-adults-with-inherited-high-cholesterol-condition-heterozygous-familial-hypercholesterolemia/ Wed, 29 Apr 2026 15:06:41 +0000 https://clinicaltrials.eu/trial/study-of-laroprovstat-azd0780-tablets-to-lower-cholesterol-levels-in-adults-with-inherited-high-cholesterol-condition-heterozygous-familial-hypercholesterolemia/ This study focuses on people with Heterozygous Familial Hypercholesterolemia, an inherited condition that causes high levels of LDL cholesterol (often called “bad” cholesterol) in the blood. The research evaluates a new medication called AZD0780 (laroprovstat), which is given as a film-coated tablet that patients take by mouth.

The purpose of this study is to determine how well AZD0780 works compared to placebo in lowering LDL cholesterol levels in patients who already take other cholesterol-lowering medications. The study will last for 52 weeks, during which participants will receive either AZD0780 or placebo in addition to their usual cholesterol-lowering treatments.

Throughout the study, researchers will monitor changes in various types of cholesterol and related substances in the blood, including apolipoprotein B, non-HDL cholesterol, total cholesterol, and lipoprotein(a). The main focus will be on measuring how much the LDL cholesterol levels change after 12 weeks of treatment.

]]> Study on Inclisiran, Alirocumab, and Rosuvastatin for Children with Familial Hypercholesterolemia https://clinicaltrials.eu/trial/study-on-inclisiran-alirocumab-and-rosuvastatin-for-children-with-familial-hypercholesterolemia/ Wed, 29 Apr 2026 15:04:13 +0000 https://clinicaltrials.eu/trial/study-on-inclisiran-alirocumab-and-rosuvastatin-for-children-with-familial-hypercholesterolemia/ This clinical trial is focused on studying a condition called heterozygous familial hypercholesterolemia (HeFH), which is a genetic disorder that causes high levels of cholesterol in the blood. The study aims to compare the effectiveness of different treatments in children with this condition. The treatments being tested include a combination of rosuvastatin, a medication taken orally, and either alirocumab or inclisiran, both of which are given as injections under the skin. These treatments will be compared to the standard therapy of rosuvastatin alone.

The purpose of the study is to see how well these treatments work in lowering cholesterol levels to a specific target after 104 weeks. Participants in the study will receive one of the treatment combinations or the standard therapy. The study will last for about two years, during which participants will have regular check-ups to monitor their cholesterol levels and overall health. The goal is to determine which treatment is most effective in helping children with HeFH reach healthier cholesterol levels.

Throughout the study, participants will be monitored for changes in their cholesterol levels and other health markers. The study will also assess the impact of the treatments on the thickness of the arteries, which is measured using a method called carotid intima-media thickness (CIMT). Additionally, the study will evaluate the quality of life of participants using a questionnaire designed for children. This research is important for finding better ways to manage high cholesterol in children with HeFH and improving their long-term health outcomes.

]]> Study on the Safety and Effectiveness of Inclisiran in Children Aged 2 to Under 12 with Homozygous Familial Hypercholesterolemia https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-inclisiran-in-children-aged-2-to-under-12-with-homozygous-familial-hypercholesterolemia/ Wed, 29 Apr 2026 15:03:30 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-inclisiran-in-children-aged-2-to-under-12-with-homozygous-familial-hypercholesterolemia/ This clinical trial is focused on studying a condition called homozygous familial hypercholesterolemia, a genetic disorder that causes very high levels of cholesterol in the blood from a young age. The study is testing a treatment called inclisiran, which is also known by its code name KJX839. Inclisiran is a medication given as an injection and is being compared to a placebo to see how well it works in lowering cholesterol levels in children aged 2 to under 12 years.

The purpose of the study is to evaluate the safety and effectiveness of inclisiran in reducing levels of LDL-cholesterol, often referred to as “bad cholesterol,” in children with this condition. The study is designed in two parts: the first year involves a comparison between inclisiran and a placebo, while the second year allows all participants to receive inclisiran. This approach helps researchers understand both the immediate and longer-term effects of the treatment.

Participants in the study will receive injections of inclisiran or a placebo and will have regular check-ups to monitor their cholesterol levels and overall health. The study aims to see how much inclisiran can lower LDL-cholesterol and to ensure it is safe for use in children. The trial will also track any side effects and assess the children’s growth and development throughout the study period.

]]> Study on the Safety and Effectiveness of Inclisiran for Children Aged 6 to Under 12 with Familial Hypercholesterolemia https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-inclisiran-for-children-aged-6-to-under-12-with-familial-hypercholesterolemia/ Wed, 29 Apr 2026 15:03:07 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-inclisiran-for-children-aged-6-to-under-12-with-familial-hypercholesterolemia/ This clinical trial is focused on studying a condition called Heterozygous Familial Hypercholesterolemia, which is a genetic disorder that causes high levels of low-density lipoprotein cholesterol (LDL-C), often referred to as “bad cholesterol.” The study is specifically for children aged 6 to under 12 years who have this condition. The treatment being tested is a medication called Inclisiran, which is also known by its code name KJX839. Inclisiran is given as an injection and is designed to help lower LDL-C levels in the blood.

The purpose of the study is to evaluate the safety and effectiveness of Inclisiran in reducing LDL-C levels in children with this condition. The study is divided into two parts. In the first year, participants will receive either Inclisiran or a placebo, which is a substance with no active medication. In the second year, all participants will receive Inclisiran. The study will monitor changes in LDL-C levels and other health markers over time to assess the impact of the treatment.

Throughout the study, participants will have regular check-ups to track their health and any changes in their cholesterol levels. The study aims to provide valuable information on how well Inclisiran works in children with Heterozygous Familial Hypercholesterolemia and to ensure that it is safe for use in this age group. This research could lead to better treatment options for managing high cholesterol in children with this genetic condition.

]]> Study of Bempedoic Acid for Children Aged 6-17 with Familial Hypercholesterolemia https://clinicaltrials.eu/trial/study-of-bempedoic-acid-for-children-aged-6-17-with-familial-hypercholesterolemia/ Wed, 29 Apr 2026 14:59:12 +0000 https://clinicaltrials.eu/trial/study-of-bempedoic-acid-for-children-aged-6-17-with-familial-hypercholesterolemia/ This clinical trial is focused on studying a condition called Heterozygous Familial Hypercholesterolemia (HeFH), which is a genetic disorder that causes high levels of cholesterol in the blood. The treatment being tested in this study is a medication called Bempedoic acid, also known by its code name ETC-1002. This medication is being tested in the form of a film-coated tablet and an oral suspension, which means it can be taken by mouth either as a pill or a liquid.

The purpose of the study is to understand how Bempedoic acid works in children aged 6 to 17 who have HeFH. The study will look at how the body processes the medication and how it affects cholesterol levels. Participants will take the medication once daily for a period of 8 weeks. During this time, researchers will monitor the levels of the medication in the blood and observe any changes in cholesterol levels. The study will also assess how well children tolerate the medication, including its taste and ease of swallowing.

This study is important because it aims to provide more information about the safety and effectiveness of Bempedoic acid in young patients with HeFH. By understanding how the medication works in children, researchers hope to find better ways to manage high cholesterol levels in this age group. The study is expected to continue until 2025, allowing enough time to gather comprehensive data on the medication’s effects.

]]> Study on Long-Term Effects of Lerodalcibep for Lowering Cholesterol in Patients with Familial Hypercholesterolemia or Cardiovascular Disease Risks https://clinicaltrials.eu/trial/study-on-long-term-effects-of-lerodalcibep-for-lowering-cholesterol-in-patients-with-familial-hypercholesterolemia-or-cardiovascular-disease-risks/ Wed, 29 Apr 2026 14:30:16 +0000 https://clinicaltrials.eu/trial/study-on-long-term-effects-of-lerodalcibep-for-lowering-cholesterol-in-patients-with-familial-hypercholesterolemia-or-cardiovascular-disease-risks/ This clinical trial is focused on studying the effects of an investigational drug called Lerodalcibep, also known by its code name LIB003. The study is designed for patients with certain types of high cholesterol, specifically those with Homozygous and Heterozygous Familial Hypercholesterolemia, as well as individuals with Cardiovascular Disease or those at high risk for such diseases. These conditions are characterized by high levels of cholesterol in the blood, which can lead to heart problems. The treatment involves a solution for injection that is administered under the skin.

The purpose of the study is to evaluate the long-term safety and effectiveness of Lerodalcibep in reducing cholesterol levels. Participants in the study will receive the drug once a month for a period of up to 72 weeks. The study aims to see how well the drug works in lowering cholesterol levels and to monitor any side effects that may occur over time. Patients involved in the study will continue their current cholesterol-lowering treatments while receiving the investigational drug.

Throughout the study, participants will have regular check-ups to assess their health and the impact of the treatment. This includes monitoring cholesterol levels and other health indicators to ensure the safety and effectiveness of the drug. The study is an extension of previous research and includes patients who have already participated in earlier phases of the trial. The goal is to provide additional information on how Lerodalcibep can help manage cholesterol levels in patients with high cardiovascular risk.

]]> Study on the Effectiveness of Enlicitide Chloride in Reducing Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease https://clinicaltrials.eu/trial/study-on-the-effectiveness-of-enlicitide-chloride-in-reducing-cardiovascular-events-in-patients-with-atherosclerotic-cardiovascular-disease/ Wed, 29 Apr 2026 14:28:49 +0000 https://clinicaltrials.eu/trial/study-on-the-effectiveness-of-enlicitide-chloride-in-reducing-cardiovascular-events-in-patients-with-atherosclerotic-cardiovascular-disease/ This clinical trial is focused on studying the effects of a new treatment called MK-0616 on people who are at high risk for serious heart problems. The main condition being studied is Atherosclerotic Cardiovascular Disease (ASCVD), which is a type of heart disease caused by the buildup of fats, cholesterol, and other substances in and on the artery walls. This buildup can lead to major heart-related events, such as heart attacks or strokes.

The purpose of the study is to evaluate how well MK-0616, a film-coated tablet containing the active substance enlicitide chloride, can reduce the risk of these major heart events compared to a placebo. Participants in the study will be randomly assigned to receive either the MK-0616 tablet or a placebo tablet. The study will monitor participants over a period to see if the treatment helps in delaying or preventing serious heart-related events.

Throughout the study, participants will take the medication orally and will be regularly monitored by healthcare professionals. The study aims to provide valuable information on the safety and effectiveness of MK-0616 in reducing the risk of major adverse cardiovascular events in individuals with high cardiovascular risk. This research could potentially lead to new treatment options for people with heart disease.

]]> Study of MK-0616 for Adults with Familial Hypercholesterolemia https://clinicaltrials.eu/trial/study-of-mk-0616-for-adults-with-familial-hypercholesterolemia/ Wed, 29 Apr 2026 14:26:49 +0000 https://clinicaltrials.eu/trial/study-of-mk-0616-for-adults-with-familial-hypercholesterolemia/ This clinical trial is focused on studying a condition known as Heterozygous Familial Hypercholesterolemia (HeFH), which is a genetic disorder that causes high levels of low-density lipoprotein cholesterol (LDL-C), often referred to as “bad cholesterol.” The study is testing a new treatment called MK-0616, which is a film-coated tablet containing the active substance enlicitide chloride. The purpose of the study is to evaluate how effective and safe MK-0616 is in reducing LDL-C levels in adults with HeFH.

Participants in the study will be randomly assigned to receive either the MK-0616 tablet or a placebo, which looks like the MK-0616 tablet but does not contain the active substance. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will last for a total of 52 weeks, with the main focus on changes in LDL-C levels at Week 24 and Week 52.

Throughout the study, participants will have regular check-ups to monitor their cholesterol levels and overall health. The study will also track any side effects or adverse events that may occur. The goal is to determine if MK-0616 can safely and effectively lower LDL-C levels in people with HeFH, potentially offering a new treatment option for managing this condition.

]]> Study on Long-Term Safety of Inclisiran for Patients with Familial Hypercholesterolemia Who Completed Previous Adolescent Studies https://clinicaltrials.eu/trial/study-on-long-term-safety-of-inclisiran-for-patients-with-familial-hypercholesterolemia-who-completed-previous-adolescent-studies/ Wed, 29 Apr 2026 14:25:53 +0000 https://clinicaltrials.eu/trial/study-on-long-term-safety-of-inclisiran-for-patients-with-familial-hypercholesterolemia-who-completed-previous-adolescent-studies/ This clinical trial is focused on studying the long-term safety and tolerability of a medication called inclisiran in individuals with a condition known as familial hypercholesterolemia. Familial hypercholesterolemia is a genetic disorder that causes high levels of cholesterol in the blood, which can increase the risk of heart disease. The study involves participants who have already completed previous studies named ORION-16 or ORION-13. Inclisiran, also known by its code name KJX839, is administered as a solution for injection under the skin.

The purpose of this study is to evaluate how well participants tolerate inclisiran over a long period. Participants will continue their current cholesterol-lowering treatments, such as statins or ezetimibe, without any planned changes in medication or dosage during the study. The study will monitor any side effects or adverse events that occur, as well as changes in vital signs, growth, and laboratory test results.

Throughout the study, researchers will also measure changes in LDL cholesterol levels, which is often referred to as “bad” cholesterol, from the beginning of the study to the end. This will help determine the effectiveness of inclisiran in managing cholesterol levels in participants with familial hypercholesterolemia. The study is designed to provide valuable information on the long-term use of inclisiran for individuals with this genetic condition.

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