Hypercholesterolemia

34

Review clinical trials related to Hypercholesterolemia. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Post-Marketing Clinical Trial of Pemafibrate in Patients with Hypercholesterolemia and Inadequate Response to Statins

To investigate the efficacy and safety of Pemafibrate 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.

Participants needed: 120
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Kowa Company, Ltd.Updated: Jul 13, 2026Locations: 10
Eligibility criteria

Patients with hypercholesterolemia aged 18 years or older at the time of obtaini... [+10]

Patients who require administration of prohibited drugs during the post-marketin... [+27]

Status: Recruiting

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels). The aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug once a week * How much study drug is in the blood at different times

Participants needed: 420
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Regeneron PharmaceuticalsUpdated: Jul 1, 2026Locations: 6
Eligibility criteria

Participant plans to initiate or change dose of lipid-lowering therapy [+1]

Status: Recruiting

Causes and Natural History of Dyslipidemias

This study will evaluate people with dyslipidemias - disorders that affect the fat content in the blood. Fats, or lipids, such as cholesterol and triglycerides, are carried in the blood in particles called lipoproteins. These particles are involved in causing blood vessel diseases that can lead to conditions like atherosclerosis (hardening of the arteries) or heart attack. Participants will undergo accepted medical tests and procedures to evaluate their condition. Most of the test results are helpful in making a diagnosis and in guiding treatment. People with lipid disorders are eligible for this study. Representative types of patients include those with: * Plasma cholesterol levels greater than 200 mg/dl or less than 120 mg/dl * Plasma LDL-C levels greater than 130 mg/dl or less than 70 mg/dl * Plasma HDL-C levels greater than 70 mg/dl or less than 25 mg/dl * Unusual cholesterol deposits or xanthomas (nodules of lipid deposits on the skin) Children under 2 years of age are excluded from the study. Participants will undergo some or all of the following procedures: \- Plasma evaluation. Apolipoproteins (plasma proteins involved in metabolism of cholesterol, triglycerides, phospholipids, and proteins in the blood) and enzymes involved in lipid metabolism are measured....

Participants needed: 2,000
Trial details
Age: 2-100Biological sex: AllType: ObservationalSponsor: National Heart, Lung, and Blood Institute (NHLBI)Updated: Jun 30, 2026Locations: 1
Eligibility criteria

Children >= 2 years of age and >12 kg and adults [+5]

Status: Recruiting

A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.

Participants needed: 126
Trial details
Phase: Phase 2, Phase 3Age: 18-85Biological sex: AllType: InterventionalSponsor: Beijing Suncadia Pharmaceuticals Co., LtdUpdated: Jun 16, 2026Locations: 1
Eligibility criteria

Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to pr... [+3]

History of severe allergies/hypersensitivity reactions, or clinically significan... [+14]

Status: Recruiting

Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

The ULTRA-CKD trial is a prospective, randomized, open-label, multicenter trial designed to compare the efficacy and safety of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy in patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD). Patients with CKD are at very high risk for ASCVD. In this population, it is important to establish a lipid-lowering strategy that optimizes cardiovascular outcomes while ensuring long-term safety. While high-intensity statins are generally considered as initial treatment option for secondary prevention, the optimal strategy for CKD patients remains to be clinicaly defined. This study aims to evaluate whether the combination of moderate-intensity statin and ezetimibe is non-inferior to high-intensity statin monotherapy in terms of 3-year composite of major adverse cardiovascular events.

Participants needed: 1,952
Trial details
Age: 19-85Biological sex: AllType: InterventionalSponsor: Yonsei UniversityUpdated: Jun 16, 2026Locations: 1
Eligibility criteria

Age 19-85 years. [+6]

Baseline LDL cholesterol <55 mg/dL in the absence of statin therapy. [+5]

Status: Not yet recruiting

A Post-Marketing Clinical Trial of Pemafibrate in Patients with Hypercholesterolemia and Inadequate Response to Statins

To investigate the efficacy and safety of Pemafibrate 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.

Participants needed: 120
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Kowa Company, Ltd.Updated: Jun 8, 2026
Eligibility criteria

Patients with hypercholesterolemia aged 18 years or older at the time of obtaini... [+10]

Patients who require administration of prohibited drugs during the post-marketin... [+27]

Status: Recruiting

Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention

This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins. Lowering low-density lipoprotein cholesterol (LDL-C) is essential to reduce the risk of cardiovascular events. While PCSK9 inhibitors are effective, many patients treated with a single agent do not reach recommended LDL-C targets, especially those who cannot take statins. Inclisiran and alirocumab reduce LDL-C through different mechanisms. Inclisiran decreases the production of PCSK9 in the liver, while alirocumab binds circulating PCSK9 in the blood. Combining these therapies may lead to a greater reduction in LDL-C levels. In this randomized, open-label clinical trial, approximately 60 patients in secondary prevention will be assigned to one of three groups: inclisiran alone, alirocumab alone, or a combination of both treatments. Patients will be followed for 9 months with regular clinical and laboratory assessments. The main goal of the study is to determine whether combination therapy leads to greater LDL-C reduction compared to each treatment alone. Secondary objectives include assessing the proportion of patients achieving target LDL-C levels and evaluating treatment safety and tolerability.

Participants needed: 60
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: University Medical Centre LjubljanaUpdated: Jun 2, 2026Locations: 1
Eligibility criteria

Adults aged ≥18 years [+6]

Eligibility for PCSK9 inhibitor therapy solely based on elevated lipoprotein(a)... [+10]

Status: Not yet recruiting

Vascular Intervention Strategies Trial for Alzheimer's

The proposed pharmacist-led study is a feasibility pilot trial for the management of vascular risk factors of hypertension and hypercholesterolemia in 10 APOE ε4 carriers, 50-75, at-risk for dementia. All participants will receive angiotensin receptor blockers (ARBs) for high blood pressure, and hydrophilic statins (or a non-statin alternative) for high cholesterol over a six-month period.

Participants needed: 10
Trial details
Phase: Phase 2Age: 50-75Biological sex: AllType: InterventionalSponsor: University of Southern CaliforniaUpdated: May 4, 2026Locations: 1
Eligibility criteria

APOE ε4 carrier (homozygote or heterozygote) [+6]

One minute standing SBP < 110 mm Hg [+17]

Status: Recruiting

Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia

VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia. VERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C) and triglycerides. This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.

Participants needed: 36
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Verve Therapeutics, Inc.Updated: Apr 28, 2026Locations: 10
Eligibility criteria

Refractory hypercholesterolemia [+1]

Active or history of chronic liver disease [+2]

Status: Recruiting

Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile

The goal of this clinical trial is to assess the effects of corn and avocado oils as part of controlled feeding diets on the cardiometabolic risk factor profile in men and women with mild-to-moderately elevated levels of non-high-density lipoprotein cholesterol (non-HDL-C). Participants will be asked to consume the controlled feeding diet for two separate 21 day conditions, and will consume their regular diet for a 21 day washout period between the two conditions. Additionally, participants will be asked to come into the clinic on 7 different occasions, including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 21-d diet condition (visits 3 \& 6, day 19 and visits 4 \& 7, day 21), and a visit at the conclusion of the washout phase/start of the second diet condition (visit 5, day 0).

Participants needed: 54
Trial details
Age: 18-74Biological sex: AllType: InterventionalSponsor: Midwest Center for Metabolic and Cardiovascular ResearchUpdated: Apr 17, 2026Locations: 1
Eligibility criteria

Male or female 18 - 74 years of age, inclusive. [+9]

Known allergy or sensitivity to study product or any ingredients of the study pr... [+26]

Status: Recruiting

Pharmacogenomic Informed Statin Prescribing

Statins are the most cost-effective medications to lower cholesterol and cardiovascular disease (CVD) risk. However, many patients at high-risk for CVD do not accept or adhere to statins. This gap in patient's use of statins limits the full impact of these effective medications resulting in higher cholesterol levels and CVD risk. The main barriers to using statins are patients' perceived lack of benefit, excess risk of statin toxicity as well as their misperceptions of their CVD risk. Statin pharmacogenomic testing - an application of precision medicine - is a readily available, feasible, and inexpensive intervention that addresses this barrier by using genetic testing to identify the nearly 1 out of 2 patients with enhanced benefit and/or reduced risk of statin toxicity or increased risk for CVD. By communicating statin pharmacogenomic test results to Veterans at high-risk for CVD not taking statin therapy, the investigators aim to improve patients' perceptions of their risk of CVD and statins and, in turn, their acceptance of and adherence to statins to reduce their cholesterol levels and CVD risk.

Participants needed: 410
Trial details
Age: 40-75Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Apr 13, 2026Locations: 2
Eligibility criteria

Are a Veteran [+7]

Non-Veterans [+14]

Status: Not yet recruiting

Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome

The goal of this clinical trial is to evaluate whether triple lipid-lowering therapy (atorvastatin, ezetimibe, and bempedoic acid) is more effective than dual therapy (atorvastatin and ezetimibe) in reducing LDL cholesterol levels in adults with acute coronary syndrome. It will also assess the safety of the treatment. The main questions it aims to answer are: * Does triple therapy result in greater reduction in LDL-C compared to dual therapy? * What adverse effects occur in participants receiving triple therapy? Researchers will compare triple therapy to dual therapy to determine its effectiveness in lowering LDL-C levels. Participants will: * Receive either dual or triple lipid-lowering therapy for 3 months * Attend regular follow-up visits for clinical assessment and laboratory testing * Undergo lipid profile evaluation at baseline and at the end of the study

Participants needed: 120
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Punjab Institute of CardologyUpdated: Apr 9, 2026Locations: 1
Eligibility criteria

Must be older than 18 years, male or female. [+4]

Intolerance or hypersensitivity to study drugs. [+4]

Status: Not yet recruiting

A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

Participants needed: 103
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Daiichi SankyoUpdated: Mar 19, 2026
Eligibility criteria

Age ≥18 years [+6]

Known or suspected heterozygous or homozygous familial hypercholesterolaemia or... [+21]

Status: Not yet recruiting

Electronic Letters to Improve Patient Activation in IHD: The NUDGE-IHD Trial

The goal of this clinical trial is to learn whether simple electronic information letters can increase patient activation and improve risk-factor monitoring in adults in Denmark with ischemic heart disease (IHD) who have LDL cholesterol above the recommended treatment target. A subgroup of participants with elevated lipoprotein(a) \[Lp(a)\] will also be randomized to receive an additional information letter. The main questions the study aims to answer are: * Does sending an electronic letter about elevated LDL cholesterol increase the proportion of patients who have at least one LDL-cholesterol test within 6 months? * Among patients with ischemic heart disease and elevated Lp(a), does receiving an information letter about Lp(a) increase patient activation, reflected by cardiometabolic risk-factor monitoring? Because this is a randomized trial, researchers will compare people who receive the electronic letter(s) with people who do not receive any letter to determine whether the letters encourage patients to take action, such as obtaining laboratory tests or contacting their doctor. Participants will: * Receive an electronic letter through Denmark's national digital mailbox system (Digital Post) or receive no letter, depending on random assignment. * Continue their usual health care, with no additional visits, treatments, or procedures required for the study. * Have all study information collected from existing Danish nationwide health registries.

Participants needed: 100,000
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Tor Biering-SørensenUpdated: Mar 10, 2026Locations: 1
Eligibility criteria

Alive on identification date [+3]

Nursing home residents [+1]

Status: Recruiting

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology/American Heart Association and US Preventive Services Task Force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. The overarching goals of this proposal are to (1) determine the efficacy of EMERALD at lowering low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non-HDL-C) among at-risk Emergency Department (ED) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ED-based cardiovascular disease prevention strategies.

Participants needed: 130
Trial details
Phase: Phase 2Age: 40-75Biological sex: AllType: InterventionalSponsor: Wake Forest University Health SciencesUpdated: Feb 27, 2026Locations: 1
Eligibility criteria

Evaluation for Acute Coronary Syndrome [+9]

ST-Segment Elevation Myocardial Infarction (STEMI) Activation [+14]

Status: Recruiting

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy

Evaluation of adherence, persistence, and efficacy of treatment with Bempedoic acid in a real-life Italian population.

Participants needed: 1,500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Federico II UniversityUpdated: Jan 29, 2026Locations: 1Duration: 3 Years
Eligibility criteria

Patients under Bempedoic acid treatment

Age < 18 years o > 80 years [+1]

Status: Not yet recruiting

Activate Tennessee: A CHW-Supported Program for Patient Activation

The research project will involve community health workers (CHWs) that will help participants to better understand their medical conditions and to responsibly manage their medical needs. The project will focus on participants with the greatest medical needs and those that have many different illnesses at the same time. CHWs will help guide participants in focusing on improving their knowledge and confidence to manage their health conditions and to improve their ability to understand how the healthcare system works. This will give participants the opportunity to take charge of their illnesses and possibly improve their health conditions over time. The CHWs will work together with participants to develop a health plan focused on their specific health needs.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Meharry Medical CollegeUpdated: Dec 12, 2025
Eligibility criteria

18 years and older, [+3]

Status: Recruiting

Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia

The primary outcome is to evaluate the effect of Cynacol on the change in LDL-C levels compared to Metacol after 90 days of supplementation. The secondary outcomes are to evaluate: \- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.

Participants needed: 40
Trial details
Age: 35-70Biological sex: AllType: InterventionalSponsor: Fondazione IRCCS Policlinico San Matteo di PaviaUpdated: Dec 19, 2025Locations: 1
Eligibility criteria

age between 35-70 years [+3]

personal history of cardiovascular disease or equivalent risk factors [+7]

Status: Recruiting

Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels

The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol. The main questions it aims to answer are: * Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone? * Does lipodia help improve other health outcomes, like how confident participants feel in managing their health? Researchers will compare two groups: * Intervention group: Participants use the lipodia intervention and continue their usual treatment. * Control group: Participants continue with their usual treatment only. Participants will: * Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months * Have blood tests at each lab visit to check their cholesterol and other blood fat levels * Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)

Participants needed: 272
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Gaia AGUpdated: Aug 22, 2025Locations: 1
Eligibility criteria

Age ≥ 18 [+8]

Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condit... [+10]

Status: Recruiting

Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study. Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.

Participants needed: 2,000
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Stephen NichollsUpdated: Aug 14, 2025Locations: 22
Eligibility criteria

18 years of age [+1]

LDL <1.4mmol/L at baseline [+3]

Status: Recruiting

A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe

The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.

Participants needed: 4,500
Trial details
Age: 19+Biological sex: AllType: ObservationalSponsor: Ahn-Gook Pharmaceuticals Co.,LtdUpdated: Aug 7, 2025Locations: 1
Eligibility criteria

Adults aged 19 years or older [+3]

Known hypersensitivity or history of hypersensitivity to any component of the in... [+7]

Status: Recruiting

PMMHRI-Pitavastatin Registry

The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI). Established in January 2024, the registry enrolls all patients from the Department of Cardiology and Adult Congenital Heart Diseases, the Department of Endocrinology, as well as outpatient cardiology and endocrinology clinics who are prescribed pitavastatin.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Polish Mother Memorial Hospital Research InstituteUpdated: Mar 5, 2025Locations: 1
Eligibility criteria

patient takling pitavastatin based on the 2021 Polish Lipid Guidelines

Status: Recruiting

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W \[≤31 days\]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or very-high/high risk for ASCVD including Heterozygous familial hypercholesterolemia (HeFH) on a stable diet and oral LDL-C lowering drug therapy, followed by 36-week open-label treatment with subsequent 4-week follow-up for total 52-week long-term safety and efficacy evaluation.

Participants needed: 210
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hasten Biopharmaceutical Co., Ltd.Updated: Feb 6, 2025Locations: 18
Eligibility criteria

Provision of written and signed informed consent form prior to any study-specifi... [+6]

Documented history of homozygous familial hypercholesterolemia (HoFH); [+15]