Clinical Research Directory

Berberol P for Mild-to-Moderate Hypercholesterolaemia

This randomized, controlled, multicentre clinical trial will evaluate the efficacy and safety of Berberol® P compared with Berberol® K in adults with mild-to-moderate hypercholesterolaemia. A total of 255 participants will be randomized in a 1:1:1 ratio to receive Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily for 12 weeks. The study will primarily assess whether Berberol® P is non-inferior to Berberol® K in reducing low-density lipoprotein cholesterol (LDL-C). Changes in other lipid parameters, glucose metabolism, anthropometric measures, blood pressure, and safety will also be evaluated.

Functional Cereal Products and Contribution to the Regulation of Metabolism and Obesity-induced Chronic Low-grade Inflammation.

The goal of this clinical trial is to find out the possible beneficial effects of a white wheat bread enriched with oat beta-glucans on mildly hypercholesterolemic subjects with overweight/obesity. The main questions it aims to answer are: Does the enriched bread lower total and LDL-cholesterol levels as well as the levels of inflammatory factors of the participants? Does the enriched bread positively change the composition of gut microbiota? Researchers will compare the enriched bread to a common white wheat bread to see if the enriched bread provides additional effect beyond a hypocaloric dietary plan that the participants of both groups are going to follow. Participants will: Take the enriched or the common bread every day for 8 weeks. Visit the clinic once every 2 weeks for checkups and tests.

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.

Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins

Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. This study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis). Patients participating in this study will receive injections of lipoproteins or apolipoproteins (the protein component of lipoproteins) that have been isolated and purified. These lipoproteins will be labeled with small amounts of radioactive material and sterilized before they are injected into the patient. Patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. In addition, patient will be required to follow a specially formulated diet. Patients will be weighed throughout the course of the study.

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.

Alleviation of Hypercholesterolemia Through Newly Developed Cookies Supplementedwithpumpkin (Cucurbita Pepo L.) Seeds and Walnuts (Juglans Regia L.) Among Arthrosclerosispatients.

This study is being conducted at DHQ Hospital, Jhang, under the supervision of the University of Lahore. The purpose of the trial is to find out whether specially prepared cookies made with pumpkin seeds (Cucurbita pepo L.) and walnuts (Juglans regia L.) can help improve cholesterol levels in patients with atherosclerosis. High cholesterol is one of the major causes of heart disease and stroke. Although medicines are commonly prescribed, adding natural foods with proven health benefits may help patients manage cholesterol in a safer and more affordable way. Pumpkin seeds contain healthy fats, antioxidants, and phytosterols, while walnuts provide omega-3 fatty acids, fiber, and vitamins. Together, they may improve heart health by lowering harmful cholesterol (LDL) and increasing good cholesterol (HDL). In this study, patients will be divided into two groups: Treatment group: Will receive one 100 g cookie made with pumpkin seeds and walnuts every day, in addition to their usual care. Control group: Will receive usual care without the supplemented cookies. Blood samples will be taken at the start, at 3 weeks, and at 6 weeks to measure cholesterol, triglycerides, LDL, and HDL levels. Researchers will follow up with participants regularly to ensure safety and compliance. The study will help determine whether these cookies can be recommended as a natural, food-based approach to reducing cholesterol and preventing complications of heart disease.

RCT for the Chinese Medicine in Treating Hypercholesterolemia

This is a randomized, double-blind, placebo-controlled clinical trial. Eligible subjects will randomized into a treatment group or placebo group. They will receive either Chinese medicine granules or placebo granules for 8 weeks followed by a 4-week observation period. The primary outcome would be the percent change in Low-density lipoprotein cholesterol levels (LDL-C) after treatment.

A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.

This study is a phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects (≥ 18 years) at very high and high risk for cardiovascular events as defined by the cardiovascular risk categories in the 2019 ESC/EAS guidelines for the management of dyslipidemias (Mach et al 2020) and elevated levels of LDL-C (≥ 70 mg/dL) despite being on a maximally tolerated high-intensity (HI) statin dose (+/- Ezetimibe). Currently, BPA is recommended ahead of injectables by German HTA body (GBA). A head-to-head trial is proposed to provide robust scientific data on the superiority of Inclisiran vs. BPA and to support the early use of Inclisiran.

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

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.

To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults

To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults

Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study

The purpose of this study is to determine the effect of two novel interventions; (1) a value-based formulary which eliminates copayment for selected high-value medications (proven to prevent heart attacks, stroke, and hospitalizations); and (2) a comprehensive patient education program aimed at lifestyle modification and optimal drug use, combined with relay of information on medication use, on the risk of adverse clinical outcomes (mortality, heart attack, stroke, need for coronary revascularization, and chronic disease related hospitalizations) in low-income seniors with chronic conditions over three years of follow-up or until March 31, 2021 (whichever comes first).

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)

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia

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.

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.

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.

Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health

Cardiovascular disease (CVD) is the leading cause of death in the US general population. Although CVD mortality rates declined for both Black and White populations during the past two decades, they are still higher in Black adults than White adults. There are also persistent disparities in CVD risk factors with higher prevalence of obesity, hypertension, and diabetes in Black compared to White populations. In addition, CVD and risk factors are more prevalent in the residents of Louisiana compared to the US general population. The Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health (CHERISH) study will use a church-based community health worker (CHW)-led multifaceted intervention to address racial inequities in CVD risk factors in predominantly Black communities in New Orleans, Louisiana. The primary aim of the CHERISH study is to compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2019 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on the Primary Prevention of Cardiovascular Disease on implementation and clinical effectiveness outcomes in predominantly Black church community members over 18 months.

A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication.

The goal of this clinical trial is to learn if an educational website can help patients make an informed decision and engage in shared decision-making with their healthcare provider regarding cholesterol lowering medication use after they have stopped statin therapy due to self-reported muscle symptoms from taking a statin medication. The main questions the trial aims to answer are: 1. Compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (SAMS) more likely to retry statin therapy? 2. Compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy? Researchers will compare people randomized to use the website to those who are receiving usual care to see if statin re-start and persistence rates change. All participants will take baseline questionnaires and receive usual care as they would if they were not in the study (e.g., visit their doctor, get labs drawn, take medication as prescribed). Patients randomized to the website arm will be asked to engage with content in a website which is anticipated to take most patients approximately 30-minutes. Their clinician will then contact them for a follow-up visit as needed.

Improving Lipid Optimization Quality and Treatment Options in ASCVD

The goal of this project is to study different approaches to improve the utilization of guideline directed medicines to lower cholesterol in patients with or at high risk of atherosclerosis (cholesterol buildup in the arteries).

WB-EMS Effects on Cardiometabolic Risk Factors

From the age of 50 onwards, there is a disproportionate decline in muscle strength, mass and function, which can be prevented or at least delayed by physical training. Unfortunately, many training programmes are very time-consuming and strenuous and are therefore not carried out consistently. Whole-body electromyostimulation (WB-EMS), a technology in which all major muscle groups are stimulated with an adjusted stimulation level, could be a time-effective and joint-friendly alternative. However, there are some contraindications to the widespread use of this technology, which are particularly common in middle-aged and elderly people. For example, high blood pressure, which affects more than half of men over the age of 50 in Germany, is considered a contraindication for WB-EMS training. However, this assessment is not very reliable; at least, acute WB-EMS application does not lead to an increase in blood pressure. In addition, there are no study results available for long-term WB-EMS application in people with high blood pressure. The present study particularly investigate whether and to what extent several weeks of WB-EMS training has an effect on resting blood pressure in people with mild blood pressure. Additionally, the effect of WB-EMS on other cardiometabolic risk factors and physical function will be addressed.

Study on the Effect of the Intake of a Calcium-bicarbonate Water on Cholesterol Levels

The goal of this study is to evaluate the hypolipidemic effect (reduction of Low Density Lipoprotein Cholesterol "LDL-C" values) of calcium-bicarbonate mineral water "Lete" (alkaline water, high in bicarbonate and calcium ions and low in sodium) compared to control oligomineral water "Sorgesana" on healthy volunteers

Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol

The goal of this clinical trial is to test whether one pill that combines ezetimibe, rosuvastatin, and amlodipine can safely lower cholesterol and blood pressure in Korean adults with high blood pressure and high cholesterol.

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.