Investigating the Effects of Lipid-therapy Intensification With Alirocumab on Endothelial Function,...
AtherosclerosisHypercholesterolemia2 moreA prospective, open-label, pilot study with 24 cardiovascular high risk patients (N=24) having insufficient Low density lipoprotein cholesterin (LDL-C) reduction despite standard of care lipid-modifying therapies (LMTs), to evaluate the effects of potent lipid-therapy intensification via the recently approved monoclonal, human anti-PCSK9 antibody Alirocumab on endothelial function, inflammation, lipoprotein particle subfractions, carotid arteries and post-prandial lipemia in clinical routine at the Medical University of Graz.
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy...
HypercholesterolemiaAtherosclerosis1 moreThe purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered...
HypercholesterolemiaPrimary Objective: To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects. Secondary Objectives: To assess the pharmacokinetic profile of a single SC dose of alirocumab. To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density lipoprotein cholesterol (LDL-C) and other lipid parameters. To assess the immunogenicity of a single SC dose of alirocumab.
Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
Heterozygous Familial HypercholesterolemiaThe primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH).
Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY)...
HypercholesterolaemiaPrimary Objective: To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings. Secondary Objective: Device-related: To collect real-use (usability) data assessing the robustness and user interaction of SYDNEY and the current alirocumab auto-injector device (which is referred to as AI) in supervised settings. Pharmacokinetics: To compare alirocumab pharmacokinetics (PK) administered using SYDNEY and AI. To evaluate alirocumab PK administered using SYDNEY. Anti-drug antibodies: To evaluate the development of anti-drug (alirocumab) antibodies (ADA). Efficacy/pharmacodynamics: To compare the percent and absolute change in low-density lipoprotein cholesterol (LDL-C) using SYDNEY and AI. To evaluate the percent and absolute change in LDL-C using SYDNEY. Safety: To evaluate the safety and tolerability of alirocumab using both SYDNEY and AI.
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial...
Homozygous Familial Hypercholesterolemia HoFHTo describe the safety and tolerability of evolocumab in participants with homozygous familial hypercholesterolemia (HoFH) in India. All participants will receive evolocumab over an 8-week period.
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein...
ASCVDRisk Factor2 moreThis is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).
Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients
DyslipidemiasFamilial Hypercholesterolemia1 moreThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial hypercholesterolemia and severe hypertriglyceridemia.
Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in...
Primary HypercholesterolemiaThe purpose of this study is to evaluate Pharmacokinetic Properties and Safety after administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in the healthy adults.
Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers
HyperlipidemiasHypercholesterolemiaA prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.