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Hyperlipoproteinemia Type II clinical trials

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NCT ID: NCT05218005 Recruiting - Clinical trials for Acute Coronary Syndrome

Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia

ACCURATE
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

ACCURATE will test the hypothesis that opportunistic genetic testing for Familial Hypercholesterolemia (FH) in patients admitted to hospital with an acute coronary syndrome will increase the diagnosis of FH and will impact patient care and outcomes. The study will recruit patients admitted to hospital with an acute coronary syndrome, and research-based genetic testing will be conducted for known FH-causing genetic variants. The results will be returned to the patients' treating physicians. The primary endpoint will be the number of patients with a new diagnosis of FH. The secondary endpoints will be the proportion of patients who undergo intensification of lipid-lowering therapy, the lowest LDL cholesterol level achieved, and the proportion of patients reaching guideline recommended lipid targets in the 12 months after the index acute coronary syndrome.

NCT ID: NCT05217667 Active, not recruiting - Clinical trials for Homozygous Familial Hypercholesterolemia

Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH)

Gateway
Start date: April 22, 2022
Phase: Phase 2
Study type: Interventional

Participants with documented homozygous familial hypercholesterolemia (HoFH) who have provided informed consent will receive 2 open-label doses of ARO-ANG3 and be evaluated for safety and efficacy parameters through 36 weeks. Participants who complete the first 36 week treatment period may opt to continue in an additional 24-month extension period during which they will receive up to 8 doses open-label doses of ARO-ANG3.

NCT ID: NCT05181553 Recruiting - Clinical trials for Cardiovascular Diseases

Unravelling the Impact of Diet on Cardiovascular Health in Heterozygous Familial Hypercholesterolemia.

FH-Diet
Start date: January 10, 2022
Phase: N/A
Study type: Interventional

The investigators will first conduct a fully controlled dietary randomized crossover trial (RCT) including 72 adults with HeFH to investigate the impact of a diet low in red and processed meats and high in plant foods, reflecting Canada's Food Guide, in place of a standard North-American diet on LDL-cholesterol (LDL-C) levels and the plasma metabolome. Such a robust design will also lead to the identification an objective proxy to healthy diet adherence: the metabolomic signature. Secondly, by leveraging the unique resources of the ECOGENE-21 cohort, which includes 963 adults with HeFH, the investigators will evaluate the relationship between the metabolomic signature of the healthy diet and cardiovascular disease risk to determine how objective adherence to a healthy diet is associated with cardiovascular disease outcomes in HeFH.

NCT ID: NCT05142722 Active, not recruiting - Clinical trials for Hypercholesterolemia

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

BROADWAY
Start date: December 15, 2021
Phase: Phase 3
Study type: Interventional

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy

NCT ID: NCT05066932 Recruiting - Atherosclerosis Clinical Trials

Advanced Lipoproptein Profiling and Cardiovascular Risk Stratification in Familial Hypercholesterolemia

CARDIOMET
Start date: October 20, 2021
Phase:
Study type: Observational

Familial hypercholesterolaemia (FH) is a genetic disorder characterised by elevated plasma LDLC levels. The causal role of low-density lipoprotein cholesterol (LDLC) in the progression of cardiovascular disease (CVD) is indisputable: genetic, epidemiological and interventional trials have unanimously shown that a reduction in LDL-C is associated with a reduced risk of CVD. Some drawbacks related to the limitations of the analytical methods are slowly surfacing due to the lower LDLC target achieved with the combination of several new treatments. This is mainly due to the fact that LDLC is not a comprehensive marker to stratify cardiovascular risk in subjects with increased levels of other atherogenic lipoproteins. Direct measurement of the concentration of apolipoproteins involved in cholesterol and triglycerides transportation, may provide more information than the simple measure of the cholesterol contained in these particles. There is an interest in measuring the various players involved in the lipoprotein processing chain. These apolipoproteins are increasingly being considered as possible biomarkers of cardiovascular disease risk. Indeed, there is increasing evidence that advanced lipoprotein testing methods, such as multiplexed measurements of apolipoprotein panels (ApoA-I, A-II, A-IV, B-100, C-I, C-II, C-III, E), provide more detailed information on the dyslipidaemic profiles of patients compared to conventional lipid testing, finally allowing a better understanding and stratification of subclinical atherosclerosis in these patients. The main objective of this study is to compare the apolipoprotein profile of patients with FH by comparing those with associated hypertriglyceridemia (hyperTG) to those with isolated hypercholesterolaemia. Adult subjects with a molecular diagnosis of Familial Hypercholesterolemia, treated by a statin, on primary prevention, asymptomatic for cardiovascular symptoms, will be recruited and stratified according to the presence/absence of hyperTG in a case-control prospective observational study design.

NCT ID: NCT05043181 Not yet recruiting - Clinical trials for Familial Hypercholesterolemia

Exosome-based Nanoplatform for Ldlr mRNA Delivery in FH

ENDFH
Start date: December 2021
Phase: Phase 1
Study type: Interventional

mRNA therapy is a highly promising gene therapeutic strategy in the treatment of Homozygous Familial Hypercholesterolemia (HoFH). Exosomes is safe and efficient carriers for mRNA drug delivery, due to their biocompatibility, bioavailability. This first-in-human study is aimed to evaluate the safety and preliminary effectiveness of Exosome-based ldlr mRNA nanoplatform for gene therapy in HoFH.

NCT ID: NCT04958629 Not yet recruiting - Clinical trials for Familial Hypercholesterolemia

A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population

Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

To determine the prevalence and the prognosis in a corhort of patients with familial hypercholesterolemia (FH).

NCT ID: NCT04948008 Recruiting - Clinical trials for Lipid Metabolism Disorders

Evaluate the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia

Start date: November 5, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

IBI306 is a bio-innovative drug against proprotein convertase subtilisin 9 (PCSK-9) monoclonal antibody. Currently, cholesterol-lowering drugs with multiple mechanisms of action are on the market or under development. Among them, anti-PCSK-9 monoclonal antibodies have received widespread attention due to their good safety and efficacy. The results of existing preclinical studies show that IBI306 has a clear structure, good stability, and is not inferior to other drugs of its kind in terms of drug activity, animal pharmacokinetics (PK)/pharmacodynamics (PD) and safety. This study is divided into two phases: the dose exploration phase (the first phase) and the confirmatory phase (the second phase). Each stage is divided into screening period, treatment period, and safety follow-up period. The first phase of this research is the randomized design of open labels. The second stage is an open, single-arm design. The main purpose of the first phase of the study: to evaluate the tolerability and safety of multiple-dose repeated administration of IBI306 in the Chinese population with hypercholesterolemia, and to recommend the dose for the second phase. The main purpose of the second phase of the study: to evaluate the effectiveness of IBI306 in the Chinese homozygous familial hypercholesterolemia population. Secondary research purpose: To evaluate the safety and immunogenicity of IBI306 in Chinese homozygous familial hypercholesterolemia population.

NCT ID: NCT04941599 Recruiting - Clinical trials for Familial Hypercholesterolemia

2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)

Start date: February 14, 2024
Phase: Phase 2
Study type: Interventional

The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH. The Investigators plan to first study subjects with Familial Hypercholesterolemia (FH), treating them with 750 mg of 2-HOBA or placebo every 8 hours for 6 weeks.

NCT ID: NCT04929457 Enrolling by invitation - Clinical trials for Hypercholesterolemia

Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia

DigiLipids
Start date: September 1, 2021
Phase:
Study type: Observational

Longitudinal and observational registry-based cohort study of individuals participating in the national digiphysical screening program for Familial Hypercholesterolemia. The information collected in the screening process will be combined in pseudo-anonymous form with data from the National Board of Health and Welfare (registries: Cause of Death, Diagnoses according to International Classification of Diseases (ICD) and Prescribed drugs) and Statistic Sweden (Longitudinal integrated database for health insurance and labour market studies). Primary analysis: association between Familial Hypercholesterolemia and cardiovascular disease. Secondary analysis: efficacy and health economic aspects of digiphysical screening for Familial Hypercholesterolemia.