360 Clinical Trials for Various Conditions
Background: The right amount of fats in the blood (cholesterol and triglycerides) are a key part of a healthy organism. Too much or too little of these fats may manifest as diseases (dyslipidemia). There are many causes for these abnormalities, but some are genetically determined and we would like to better understand the progression of these conditions over time. Objective: This natural history study aims to learn more about dyslipidemias; how they change over time; and how they respond to therapy. We also want to develop new diagnosis methods for these conditions. With the knowledge we will acquire we hope to provide new insights, new approaches and improve the overall health of these patients. Eligibility: Individuals aged 10 years and older, residing both within and outside the United States, who have or are suspected of having a disorder that causes changes in the levels of fats in their blood (genetic dyslipidemias). Design: Participants residing within and outside the United States will be screened. Their medical records will be reviewed. They may talk to researchers about their medical history by phone, telehealth, or in person. All study visits are optional. Participants may visit the NIH up to 15 times per year, if needed. Each visit may include a physical exam and blood tests. Participants may also have an electrocardiogram (EKG). The EKG measures the electrical activity when the heart beats. Stickers attached to wires will be placed on participants legs, arms, and chest. They will lie still for about 5 minutes. In some cases, participants may remain in the study for up to 20 years.
Dyslipidemia, Atherosclerosis
A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.
Cardiovascular
The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.
Dyslipidemia
The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with dyslipidemia (part A) and multiple doses in participants with non-alcoholic fatty liver disease (part B). Blood tests will be performed to check how much LY3885125 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 49 weeks for part A and 62 weeks for part B, for a total of approximately 111 weeks.
Dyslipidemias, Non-Alcoholic Fatty Liver Disease
This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continued to meet eligibility criteria had the option to be enrolled into this study. Eligible enrolled participants initially received open-label ARO-APOC3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.
Dyslipidemias
This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.
Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases, Hyperlipoproteinemia
This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Part C will mainly evaluate the safety and tolerability of LY3561774 as well as how the body processes the study drug in Japanese participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, respectively.
Dyslipidemias
AZD8233 is a PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. This study aims to evaluate the dose-dependent reduction in LDL-C after SC administration of multiple doses of AZD8233 as well as the associated adverse effects profile. The data generated will be used to guide choice of doses, dosing regimens, and sample sizes, as well as safety and PD monitoring in the further clinical development program.
Dyslipidaemia
This is a Phase I study to assess the safety, tolerability and pharmacokinetics (PK), and pharmacodynamics (PD) of AZD8233, following subcutaneous (SC) administration of multiple ascending doses (MAD) of AZD8233 in subjects with confirmed dyslipidemia with or without type 2 diabetes.
Dyslipidemia
Two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks.
Metabolic Syndrome, Obesity, Dyslipidemias
The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.
Diabetic Retinopathy, Dyslipidemia
The study purpose is to determine the hypolipidemic effect of Alirocumab co-administered with atorvastatin on levels of triglyceride-rich lipoproteins and LDL compared to monotherapy with atorvastatin in patients with dyslipidemia secondary to nephrotic syndrome.
Nephrotic Syndrome
This is a multicenter observational cohort study with both retrospective and prospective data collection components in subjects with ASCVD. The purpose of this study is to better understand cholesterol treatment patterns in the context of a changing landscape in subjects with ASCVD.
Medical Conditions to be Studied, Dyslipidemia, ASCVD Management
This trial of pitavastatin will determine efficacy and safety in this high risk population and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.
Dyslipidemia, Obesity
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM. The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment
Hyperlipidemia, Dyslipidemia
The purpose of this two-part study is to evaluate the safety and tolerability of the study drug known as LY3202328 in healthy overweight participants in Part A, and those with dyslipidemia (abnormal blood fats) in Part B.
Dyslipidemias
The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo® on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary hyperlipidemia or mixed dyslipidemia
Hyperlipidemia, Dyslipidemia
Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy. Secondary Objectives: * To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp\[a\]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein \[VLDL\], HDL, and intermediate-density lipoprotein \[IDL\] particle number). * To assess changes in glycemic parameters with alirocumab vs. usual care treatment. * To demonstrate the safety and tolerability of alirocumab. * To evaluate treatment acceptance of alirocumab. * To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development. * To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).
Dyslipidemia
This will be a single center, open label, randomized, cross-over study in patients with dyslipidemia comparing the pharmacokinetics of rosuvastatin and atorvastatin in patients with greater than or equal to one variant allele in the SLCO1B1 gene (-11187 and/or c.521) to patients with the wild-type/wild-type genotype. The studies goal is to establish the role of genetic variation and development in key transporters on the dose-exposure relationship of two commonly used statin drugs in children. This study is the first step in a series of investigations aimed to determining the mechanisms behind variations in physiologic response, clinical efficacy and significant adverse effect risk that surround the statin drugs in children and adolescents.
Dyslipidemia
The objective of this study is * To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameter from baseline after 12 weeks of treatment * To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters
Dyslipidemia
The purpose of this study was to evaluate the effects on lipids and diet of a low-intensity dietary counseling intervention provided by the primary care physician (PCP), in patients at risk for cardiovascular diseases
Dyslipidemia
The primary objective of this study is to determine any changes in cardiovascular risk among individuals receiving a statin by assessing their multi-analyte profile.
Dyslipidemia
There is growing epidemiological evidence that consumption of red meat is associated with greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods. Research from our group has shown that a high saturated fat (SF) diet with a moderate red meat content selectively increases intermediate density lipoproteins (IDL) and larger low density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef consumption results in a preferential increase in small and medium LDL particles that are strongly related to CVD. To date, no studies have directly compared the lipoprotein effects of red meat with that of other food sources of protein in the context of both high and low saturated fat intake. The overall objective of this project is to test the hypothesis that the effects of SF on lipoprotein markers of CVD risk are influenced by sources of dietary protein. The investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol (C), apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a high content of red meat than in diets in which the major proteins are from white meat (poultry) or non-meat sources. The investigators propose a clinical trial in which 180 healthy men and women will be randomized to high SF or low SF diet groups, and within each group, consume diets with equivalent amounts of protein from red meat, white meat, and non-meat sources for 4 wks each in random order. Specifically, the investigators will test whether: (1) With high SF, the red meat diet, compared to the other protein sources, will result in higher levels of LDL-C, apoB, small and medium LDL, and total/high density lipoprotein (HDL)C; (2) With low SF, dietary protein source will not be related to any of these measurements; (3) With both the white meat and non-meat protein diets, increased LDL-C with high vs. low SF will be due primarily to increases in large LDL, whereas with red meat the additional increase in small and medium LDL will result in greater increases in plasma apoB and total LDL particle number. Aim 4 will test hypotheses that increases in small and medium LDL with high SF plus red meat are related to increased activity of hepatic lipase, a key determinant of small LDL production, and that increases in large LDL induced by high SF are related to suppression of LDL receptors. The investigators will also assess the effects of protein source and saturated fat content on markers of insulin resistance, inflammation and endothelial function.
Cardiovascular Disease, Dyslipidemia, Insulin Resistance, Inflammation
This is a two part study (Part A and Part B) that will first aim to establish the PK/PD relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm the effect using the most relevant dose(s) (Part B: \~90 subjects). Doses of 5mg, 50mg and 150mg of GSK256073 will be administered in Part A, and the dose(s) for Part B will be based on the PK/PD data from Part A. Data from Part A and Part B will be combined to decrease overall subject numbers needed in part B. Part B of the study will include a niaspan arm for relative comparison of the effects of GSK256073 and niacin on lipids and flushing
Dyslipidaemias, Dyslipidemias
The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.
Dyslipidemia, Kidney Disease
The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia
Dyslipidemia
The primary purpose of this study was to assess the effect of aspirin (ASA) on niacin extended-release (NER)-induced flushing in subjects with dyslipidemia.
Dyslipidemia
The purpose of the study is to learn whether genetics plays a role in predicting response to a commonly used and FDA (Food and Drug Administration) approved medication for lowering triglycerides and cholesterol. The hypothesis: The pharmacogenetics of genes which affect drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the body) influences how a person responds to the lipid lowering medication-fenofibrate.
Dyslipidemia
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.
Dyslipidemia