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Showing 1-20 of 42 trials
NCT07349615
The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-weeks treatment.
NCT06822790
This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133). Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \<=10% within 30 days prior to Day 1. Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria: 1. HbA1c ≤10% within 30 days prior to Day 1 2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d) 3. Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001 4. Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001 All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.
NCT05552326
The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
NCT05851066
This is a randomized, double blinded, phase 1 study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of VSA003 in healthy adult volunteerst
NCT06020950
Lifestyle changes including diet therapy and weight loss can improve hypertriglyceridemia (HTG) . Furthermore, increasing omega-3 fatty acids intake has therapeutic effects on HTG. Alpha-linolenic acid is the precursor of long-chain omega-3 fatty acid and it is abundant in sources such as chia seeds and flax seeds. Considering the high fiber and omega-3 content of chia seeds and the existing mechanisms for improving lipid profile through fiber and omega-3, animal studies have shown the positive role of chia seed consumption on lipid profile, glycemic and lipid factors, and inflammation. However, in human studies, conflicting results have been obtained and some studies have shown beneficial effects on blood lipid, glycemic, and inflammatory factors, but in some studies, no effect has been observed. The objective of this study is to determine the effects of chia seed consumption on lipids, glycemic and inflammatory factors in people with HTG.
NCT04128839
The overall goal of this project is to determine the inflammation lowering impact of anthocyanin-rich Aronia berries. Inflammation is an underlying mechanism driving the development of several diseases. While an elevation in immune signals in the systemic circulation is commonly attributed to adipose tissue, inflammation is not present in all obese individuals. Adipose tissue must become inflamed, and the inflammation trigger may come from other sources. Microorganisms (microbiome), host tissues, and immune cells residing in the gastrointestinal tract (GIT) are a key source of pro-inflammatory signals that may cause the host organism to become inflamed. Anthocyanins are bioactive compounds with established anti-inflammatory and microbiome altering properties. We hypothesize that the GIT microbiome is a key determinant of host inflammation than can be manipulated by anthocyanins-rich berries to lower inflammation. We assembled a cohort of individuals, characterized their GIT microbiome and performed anthropometric measurements, basal measures of metabolism and metabolic health, and triglyceridemic, metabolomic, and inflammation responses to a high-fat meal challenge.
NCT03120299
The purpose of this study is to conduct a multicenter randomized, double-blind, placebo-controlled clinical trial, evaluating the effects and change of lipid metabolism, especially of triglyceride after omega-3 administration in type 2 diabetes patients with hypertriglyceride.
NCT00937898
The study is designed to assess the effects of a heart-healthy diet that includes lean beef as the primary source of high quality protein on risk factors for cardiovascular disease.
NCT01527747
The purpose of this study is to test the effects of saxagliptin, a treatment for diabetes, on fasting and post-meal blood triglyceride (blood fat) levels.
NCT02681055
This is a multi-center, proof-of-principle, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD) subjects with hypertriglyceridemia.
NCT00804427
The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of two types of omega-3 fats from fish oil on plasma triglycerides. The two types of fish oil are composed of (1) omega-3 fatty acids in triglyceride form; and (2) as esterified free fatty acids (i.e. ethyl esters). Although these two types of fish oil supplements are available to the public, it remains unclear whether they are equally effective in lowering plasma triglycerides.
NCT02926027
Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons with Elevated Triglycerides (200-499) on Statin Therapy. The study is to determine progression rates of low attenuation plaque under influence of Vascepa as compared to placebo.
NCT03452228
The primary objective is to determine the change in Triglyceride (TG) levels following 12 weeks of repeated Intravenous (IV) doses of evinacumab.
NCT05685017
Adipose tissue secreting a number of adipokines which regulate insulin sensitivity, energy metabolism and vascular homeostasis, so the dysfunction of adipose tissue is linked with the incidence of obesity accompanied with insulin resistance, hypertension and cardiovascular disease (1). Obesity is known to alters the expression of adipokines due to the adipose tissue hypertrophy (2), including adiponectin, in which able to exert a potent anti-inflammatory and vascular protective effect (2). It has been proposed that adiponectin acts to prevent the vascular dysfunction due to obesity and diabetes by improves insulin sensitivity and metabolic profiles to reduce the risk factors for cardiovascular disease and protects the vasculature through its pleiotropic actions on endothelial cells, endothelial progenitor cells, smooth muscle cells and macrophages (1). The concentrations of adiponectin of 5 to 25 mg/mL had a significant inhibitory effect on the expression of monocyte adhesion and adhesion molecule induced by TNF-α in vitro. Atherosclerosis is an inflammatory disease in which adhesion molecules on arterial endothelial cells are responsible for the accumulation of monocytes/macrophages and T lymphocytes. While obesity is low-grade inflammation in which make a contribution on endothelial dysfunction by increasing the oxygen-derived free radicals (ROS) due to adipocyte hypertrophy, leads to an endoplasmic reticulum (ER) stress and mitochondrial dysfunction (3). Adiponectin is accumulated in the vasculature, and it reduced on obesity due to suppression by TNF-α and lead to adiponectin-deficiency which stimulate the significant increases of Vascular cell adhesion protein 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1) or known as CD54 in aortic intima (4). Here we investigate the level of adiponectin, ICAM-1, VCAM-1 with the incidence of MetS in obese adolescents.
NCT02113163
The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101.
NCT01047501
The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.
NCT04650152
This study is a prospective observational program within the frames of which Tricor (fenofibrate) is prescribed to patients with hypertriglyceridemia within a routine procedure as a part of the combination therapy with statins.
NCT05096455
Acute pancreatitis (AP) is a one of the potentially life-threatening complication of severe hypertriglyceridemia (HTG), with mortality around to 30%. HTG-associated PA and their complications management has to be the same as the other pancreatitis, but they are associated with the worse clinical outcomes. Triglycerides levels are correlated with the risk of pancreatitis and severity. Therapeutic plasma exchange (TPE) could provide positive effects in reducing triglyceridemia plasma levels during the acute phase of HTG-AP, and in prevention of recurrence. There is currently no difference about mortality in studies. Some authors have recommended its use only in severe HTG-AP and have precised the need of early initiation to have positive results. Despite such promising findings from studies, the effects of therapeutic plasma exchange on HTG-associated PA have never been specifically assessed and its benefits in critically ill patients with AP remains uncertain.
NCT00286234
This research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels, increase HDL-cholesterol levels and do so without altering glucose levels.
NCT00959842
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).