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Dyslipidemias clinical trials

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NCT ID: NCT06007651 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)

Start date: August 10, 2023
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT06005597 Recruiting - Clinical trials for Hypercholesterolemia

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

TANDEM
Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.

NCT ID: NCT05999110 Recruiting - Hypertension Clinical Trials

Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR)

A3-COR
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

This study aims to develop, implement, and determines the effectiveness of a personalized medicine approach to each individual's phenotype, based on an innovative physical exercise program to promote the treatment of pain and functional limitation resulting from knee osteoarthritis (KOA) in patients recovering after acute myocardial infarction (AMI) and cardiovascular risk (CVR). This randomized clinical study is important due to the lack of evidence according to the effectiveness of a personalized physical exercise intervention in people after MI or CVR with simultaneous KOA. Some studies have shown the existence of a relationship between OA and cardiovascular diseases (CVD), including coronary artery disease, stroke, congestive heart failure, peripheral arterial disease, cardiac procedures, or death related to CVD, since individuals with OA have a higher prevalence of CVD than individuals without OA. Sedentary behaviour is a risk factor for AMI, CVR and KOA, and, at the same time, physical exercise is a common non-pharmacological treatment for people suffering from these conditions, namely in the control of joint pain, gains in functional capacity, and the improvement of cardiorespiratory functional capacity, whose impact can be felt in level of quality of life. Chronic diseases have a significant impact on the global burden of disease, particularly CVD and OA, with the added presence of obesity also contributing to a high rate of all-cause morbidity and mortality, representing a substantial health burden and with growing implications for individuals, health systems and socioeconomic costs. The presence of OA seems to lead to an increased risk of developing CVD. Several mechanisms have been proposed to explain this relationship. Chronic inflammation associated with OA is one of the hypotheses suggested to explain the increased risk of CVD in these individuals. Furthermore, the pain and disability associated with OA may also limit participation in exercise/physical activity, influencing other risk factors associated with both chronic diseases, such as weight gain. The lack of studies about physical exercise intervention on people that suffered acute myocardial infarction or is in cardiovascular risk with simultaneous knee osteoarthritis and the lack of offer of phase III cardiac rehabilitation in Algarve motivated the development of this study, with the assumption of adopting a healthier lifestyle.

NCT ID: NCT05994274 Recruiting - Clinical trials for Heart Transplant Failure and Rejection

A Clinical Study of Association Between Postoperative Dyslipidemia and Organ Rejection in Transplant Patients

Start date: December 2023
Phase:
Study type: Observational

Abnormal lipid metabolism is a common complication after organ transplantation, with pathological changes in lipid parameters occurring in approximately 60-80% of cardiac transplant recipients receiving triple immunotherapy with cyclosporine, imid azathioprine, and methylprednisolone. With the significant increase in long-term survival and increasing age of transplant patients, atherosclerotic cardiovascular diseases, such as those caused by dyslipidemia, have become a major cause of transplant organ failure and recipient death. However, the causes of dyslipidemia after organ transplantation, as well as the effects and mechanisms of dyslipidemia on transplant rejection, are unknown. Previous studies have found that 1. increased lipid levels occur in recipients after heart transplantation; 2. during rejection, hepatic PCSK9 expression is increased in recipients; 3. a high-fat environment increases the immunoreactivity of human peripheral blood lymphocytes. It is suggested that PCSK9-lipid disorder-immune cell interactions may be associated with the development of transplant rejection. In this project, we propose to (1) establish a long-term follow-up system for postoperative cardiac transplantation patients in our department to track the characteristics of lipid changes in transplantation patients, to clarify the link between dyslipidemia and rejection, and to provide a strong evidence-based medical basis for the management of lipids during the perioperative period and in the postoperative period; (2) expand the dimensions of lipid-related assays under the support of the above system, and to incorporate transcriptomic, proteomic, and metabolomic research methods to elucidate transplantation rejection in a multidimensional manner. (ii) Expanding the dimensions of lipid-related assays to include transcriptomic, proteomic, and metabolomic studies to elucidate the relationship between PCSK9 and dyslipidemia in transplant patients; (iii) Adopting single-cell sequencing technology to deeply reveal the potential mechanism by which changes in lipids affect T-cell-mediated rejection of cardiac transplants. The mechanism of T-cell-mediated cardiac transplantation rejection is revealed by single-cell sequencing.

NCT ID: NCT05988866 Not yet recruiting - Clinical trials for Hypercholesterolemia

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

DIGICHOL
Start date: October 2024
Phase: N/A
Study type: Interventional

This pragmatic randomized controlled trial (RCT) with 272 patients with hypercholesterolemia aims to investigate the effectiveness of lipodia, an unguided digital health intervention for patients with hypercholesterolemia on plasma lipid levels and other clinical variables. Inclusion criteria are: age ≥ 18 years, presence of hypercholesterolemia, low-density lipoprotein cholesterol (LDL-C) levels above the risk-adapted target, stability of potential drug treatments for at least four weeks, and stability of potential hormonal treatment for at least 6 months, next to provision of informed consent and sufficient knowledge of the German language. Exclusion criteria are plans to change potential drug treatment in the upcoming 6 months, the presence of homozygous familial hypercholesterolemia (FH) or type III hyperlipidemia, receiving plasmapheresis, Lp(a) > 50 mg/dL, triglyceride (TG) above 400 mg/dL, current pregnancy, planned major operations, liver dysfunction, end-stage renal failure, and other systemic diseases that might interfere with successful study participation. Patients will be randomized and allocated to either an intervention group, in which they will receive access to lipodia in addition to treatment as usual (TAU), or to a control group, in which they will receive only TAU. The primary endpoint will be a change in plasma LDL-C levels, with six months post-allocation (T2) being the primary timepoint for assessment of effectiveness. Three months post-allocation (T1) will serve as early-response assessment of endpoints. Secondary endpoints will be patient activation, the change in levels of other plasma lipids (non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL), TG), responder rate of LDL-C, self-reported health-related quality of life, and BMI.

NCT ID: NCT05979428 Recruiting - Healthy Volunteers Clinical Trials

A Study to Look at How Safe a New Medicine (NNC0491-6075) is in Healthy People and in Participants With High Levels of Fat in the Blood

Start date: August 7, 2023
Phase: Phase 1
Study type: Interventional

The study is testing a new study medicine to treat people with high levels of fat in the blood. The main aim of the study is to see if the new study medicine is safe and how it works in the body. Participants will either get NNC0491-6075 (the new study medicine) or placebo (a "dummy medicine" without active ingredients). Which treatment participants get is decided by chance. NNC0491-6075 is a new medicine which cannot be prescribed by doctors. The study has 3 parts (Part A, Part B and Part C). In Part A, investigators look at the effect of the study medicine after a single dose in healthy participants. Participants will get the study medicine either as injection(s) under the skin or as an infusion into a vein by the study staff. In Part B, investigators look at the effect of receiving the study medicine once weekly for four weeks in participants with high levels of fat in the blood but who are otherwise healthy. Participants will get the study medicine as injections under the skin by the study staff. In Part C, investigators look at the effect of the study medicine after a single dose in healthy participants of Japanese origin. Participants will get the study medicine either as injection(s) under the skin or as an infusion into a vein by the study staff. The study will last for about 18 months in total for Part A, Part B and Part C. Participants in Part A and Part C will be in the study for about 139 days each, from screening to the final visit while in Part B they will be in the study for about 160 days from screening to the final visit.

NCT ID: NCT05970679 Completed - Clinical trials for Hypercholesterolemia, Dyslipidemia

Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A

Start date: August 17, 2022
Phase: Phase 3
Study type: Interventional

A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia

NCT ID: NCT05962372 Recruiting - Obesity Clinical Trials

Culturally Adapted Dietary Clinical Trial in PR

PRECISION
Start date: May 2, 2024
Phase: N/A
Study type: Interventional

This project will determine whether a diet culturally adapted to adults in Puerto Rico can effectively decrease cardiometabolic risk factors. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing cardiovascular, type 2 diabetes, and obesity outcomes.

NCT ID: NCT05949879 Recruiting - Clinical trials for Overweight and Obesity

Dose Response Effects of Pecan Consumption

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The bioactive compounds contained in tree nuts have been shown to beneficially affect cardiometabolic health outcomes. Pecans contain more total phenols, sterols, and flavonoids than any other tree nut. They also are a rich source of polyunsaturated fatty acids (PUFAs), fiber, vitamin A, vitamin E, folic acid, calcium, magnesium, phosphorus, potassium, and zinc. These bioactive components in pecans are likely the reason for the previously documented improvements in cardiometabolic health. The specific aims of this study are to: - Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on fasting and postprandial blood lipids. - Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on plasma markers associated with overall health. - Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on subjective and physiologic postprandial measures of hunger and satiety. Participants will be asked to: - Consume pecans daily for 28 days or maintain their current habitual diet. - Attend three short weekly visits for fasting blood craws, body measurements, and collect their next week's supply of study materials. - Attend two longer (5 h) testing visits which include consuming a standard breakfast meal and having their blood drawn periodically before and after breakfast. Researchers will compare pecan LOW, pecan MID, pecan HIGH, and the Control group to examine the physiologic effects of incorporating various dosages of pecans into one's diet.

NCT ID: NCT05910476 Recruiting - Clinical trials for Coronary Artery Disease

Comparative Study of Rosuvastatin/Ezetimib 20/10 mg and Atovastatin/Ezetimib 40/10 mg (TOLERANT Trial)

Start date: May 3, 2023
Phase: Phase 4
Study type: Interventional

the investigators would like to compare the differences between roschvastin and atovastatin in patients who require high-dose statin/ejetimib to undergo a new generation of drug elution stent implantation for cardiovascular disease and maintain LDL cholesterol below 55 mg/dL.