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Hypercholesterolemia clinical trials

View clinical trials related to Hypercholesterolemia.

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NCT ID: NCT05611528 Active, not recruiting - Clinical trials for Homozygous Familial Hypercholesterolemia

Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia

Start date: February 21, 2023
Phase: Phase 3
Study type: Interventional

This is an open-label study designed to evaluate the long-term safety and efficacy of evinacumab, a fully human ANGPTL3 antibody, in patients with homozygous familial hypercholesterolemia (HoFH), in a real-life setting in Canada. Eligible patients for this study are male and female adult patients with HoFH. Evinacumab will be added on top of the patient's background lipid-modifying therapy (LMT), including statins, ezetimibe, PCSK9 inhibitors, lomitapide or other lipid lowering therapies. This study will be conducted using an hybrid (on-site, foldable sites) approach. Patients will enter the current study, in an open-label treatment period, following their screening. This study will continue until reimbursement of evinacumab in Canada or for a maximum of 24 months. The end of study (EoS) visit will be scheduled 4 weeks after the last dose has been injected and will be followed by a 52-week follow-up.

NCT ID: NCT05526092 Active, not recruiting - Clinical trials for Overweight and Obesity

OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals

Start date: September 12, 2022
Phase: N/A
Study type: Interventional

The overall objective of this research entity is to reveal the holistic health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. This is achieved by investigation of the plasma lipids, plasma antioxidant status, fecal microbiota and fecal bile acids. Additionally the effect of the 6-week diet on posptprandial glycemia and postprandial satiety and vitality are investigated.

NCT ID: NCT05457439 Active, not recruiting - Physical Activity Clinical Trials

Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment

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

Mexico is going through a major environmental and nutritional crisis, which is related to unsustainable dietary behaviors. Sustainable diets could solve both problems together. However, in Mexico and the world, an intervention program oriented to promoting sustainable diets has not been designed. This study protocol aims to design a 3-stages, 15 weeks, sustainable-psycho-nutritional digital intervention program whose objective is to promote the adherence of the Mexican population to a sustainable diet and to evaluate its effects on dietary water and carbon footprints, metabolic biomarkers, and gut microbiota of this population. The behavior change wheel model and the guide for digital interventions design will be followed. In stage 1, the program will be designed using the sustainable diets model, and the behavior change wheel model. A sustainable food guide, sustainable recipes, and food plans as well as a mobile application will be developed. In stage 2, the intervention will be carried out for 7 weeks, and a follow-up period of 7 weeks, in a sample of Mexican young adults (18 to 35 years) randomly divided into an experimental group (n=50) and a control group (n=50). The nutritional care process model will be used. Anthropometric, biochemical, clinical, dietary, environmental, socioeconomic level and cultural aspects, nutritional-sustainable knowledge, behavioral aspects, and physical activity will be considered. Thirteen behavioral objectives will be included using successive approaches in online workshops twice a week. The population will be monitored using the mobile application that will include behavioral change techniques. In stage 3, the effects of the intervention will be assessed on the dietary water and carbon footprint, lipid profile, serum glucose, and gut microbiota composition of the evaluated population. It is expected to find improvements in health outcomes and a decrease in dietary water and carbon footprints. With this study, the first theoretical-methodological approach to the sustainable-psycho-nutrition approach will be generated.

NCT ID: NCT05425745 Active, not recruiting - Clinical trials for Hypercholesterolemia

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

BROOKLYN
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).

NCT ID: NCT05398029 Active, not recruiting - Clinical trials for Hypercholesterolemia

A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease

Start date: July 5, 2022
Phase: Phase 1
Study type: Interventional

VT-1001 is an open-label, phase 1b, single-ascending dose study that will evaluate the safety of VERVE-101 administered to patients with heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), and uncontrolled hypercholesterolemia. VERVE-101 uses base-editing technology designed to disrupt the expression of the PCSK9 gene in the liver and lower circulating PCSK9 and LDL-C in patients with established ASCVD due to HeFH. This study is designed to determine the safety and pharmacodynamic profile of VERVE-101 in this patient population.

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: NCT05192941 Active, not recruiting - Clinical trials for Hypercholesterolemia

Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

V-DIFFERENCE
Start date: April 8, 2022
Phase: Phase 4
Study type: Interventional

Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia

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: NCT05126056 Active, not recruiting - Clinical trials for Hypercholesterolemia

Lipid Lowering Effect of Plant Stanol Ester in a Drinkable Non-dairy Product

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The aim is to determine the effect of investigational products on serum LDL cholesterol.

NCT ID: NCT05118230 Active, not recruiting - Clinical trials for Primary Hypercholesterolemia

Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Start date: December 9, 2021
Phase:
Study type: Observational

This is a multi-center, prospective, comparative and non-interventional cohort study involving two cohorts, one cohort (Inclisiran Cohort) of patients treated with inclisiran in certain special territories in China (eg. Bo'ao Pilot Zone) and the other cohort (SoC Historical Cohort) of patients treated with standard of care (SoC) in routine clinical practice from EMR database.