Clinical trials: Familial Hyperlipidemia
Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia . This trial plans to enroll 760 Participants.
- Trial name
- NCT07421297
- Testing
- SYH2053 injection
- Where
- 2 sites in China
- Volunteers
- 760 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Homozygous Familial Hypercholesterolemia
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- ORION-5 (NCT03851705)
- Testing
- Inclisiran Sodium for injection
- Where
- 13 sites in Hong Kong, Israel and 6 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hyperlipemia
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450…
- Trial name
- NCT04515927
- Testing
- JS002
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Cardiovascular Disease, Metabolic Syndrome X
Inflammatory Profiles of Children at High Risk for Atherosclerosis
The purpose of this study is to evaluate levels of inflammatory mediators in children at risk for cardiovascular disease due to family history.
- Conditions
- Cardiovascular Disease, Metabolic Syndrome X, Hypercholesterolemia, Inflammation
- Trial name
- NCT00115232
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Hypercholesterolemia, Familial
Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 as add-on therapy in subjects with Homozygous Familial Hypercholesterolemia
- Trial name
- NCT00280995
- Testing
- ISIS 301012
- Where
- 6 sites in United States, Netherlands
- Volunteers
- 12 people
- Sponsor
- Kastle Therapeutics, LLC
Familial Hypercholesterolemia
Return of Actionable Variants Empirical Study
This is a genomic implementation project with ancillary studies to understand the impact on patients' health and well-being of returning genomic results to them and depositing those results in the medical record.
- Trial name
- RAVE (NCT03640234)
- Volunteers
- 418 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the…
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- NCT00694109
- Testing
- Mipomersen Sodium
- Where
- 33 sites in United States, Brazil and 5 more
- Volunteers
- 144 people
- Sponsor
- Kastle Therapeutics, LLC
Homozygous Familial Hypercholesterolemia
Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment.
- Trial name
- ODYSSEY HoFH (NCT03156621)
- Testing
- Alirocumab
- Where
- 28 sites in United States, Austria and 11 more
- Volunteers
- 69 people
- Sponsor
- Regeneron Pharmaceuticals
Familial Hypercholesterolemia, Hypercholesterolemia
Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia
Longitudinal and observational registry-based cohort study of individuals participating in the national digiphysical screening program for Familial Hypercholesterolemia.
- Trial name
- DigiLipids (NCT04929457)
- Where
- Sweden
- Volunteers
- 30,000 people
- Sponsor
- Karolinska Institutet
Hypercholesterolemia
A Study of LY3015014 in Participants With High Cholesterol
This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol.
- Trial name
- NCT01890967
- Testing
- LY3015014, Statin, Ezetimibe
- Where
- 49 sites in United States, Canada and 6 more
- Volunteers
- 527 people
- Sponsor
- Eli Lilly and Company
Hypercholesterolemia, Familial
Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high…
- Trial name
- NCT00134511
- Testing
- Torcetrapib/atorvastatin
- Where
- 6 sites in United States, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- Pfizer
Hypercholesterolaemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- NCT01617655
- Testing
- Alirocumab, Lipid Modifying Therapy (LMT)
- Where
- 35 sites in United States, Canada and 3 more
- Volunteers
- 107 people
- Sponsor
- Sanofi
High Cholesterol, Lipodystrophy, Familial Partial
The Benefits of the Measureof Epicardial Adipose Tissue During Coronary Calcium Assessment of the Refine Cardiovascular Risk Assessment at Reunion Island.
The goal of this retrospective study is to see whether patients with familial partial type 2 lipodystrophy, who are at high cardiovascular risk present a higher volume of visceral epicardial adipose tissue than other patients…
- Conditions
- High Cholesterol, Lipodystrophy, Familial Partial, Diabetes
- Trial name
- EPICAC-RUN (NCT07090629)
- Testing
- Epicardial adipose tissue measurement on the available tododensitometry used for coronary calcium scoring
- Where
- Reunion
- Volunteers
- 126 people
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Type 1 Diabetes, Familial Hypercholesterolemia
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to…
- Trial name
- Fr1dolin (NCT02750527)
- Volunteers
- 13,049 people, healthy volunteers welcome
- Sponsor
- Kinderkrankenhaus auf der Bult
Familial Hypercholesterolemia
Pilot Study for a National Screening for Familial Hypercholesterolemia
A pilot study to study the feasibility of the screening of familial hypercholesterolemia within the setting of the legal medical visits at primary school.
- Trial name
- EARLIE (NCT05271305)
- Where
- Luxembourg
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier du Luxembourg
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy.
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- RADICHOL 1 (NCT00607373)
- Testing
- mipomersen
- Where
- 10 sites in United States, Brazil and 5 more
- Volunteers
- 51 people
- Sponsor
- Kastle Therapeutics, LLC
Hypercholesterolaemia, Familial Hypercholesterolaemia
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
TRAP-HC is a multicenter, observational, longitudinal, prospective study designed to evaluate real-world treatment patterns and lipid-lowering therapy (LLT) management in patients with hypercholesterolemia, including familial…
- Conditions
- Hypercholesterolaemia, Familial Hypercholesterolaemia, CVD Risk
- Trial name
- TRAP-HC (NCT07606118)
- Volunteers
- 2,500 people
- Sponsor
- Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
Dyslipidemias, Hypercholesterolemia
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
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…
- Conditions
- Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD
- Trial name
- TANDEM (NCT06005597)
- Testing
- Combination Therapy, Monotherapy obicetrapib, Monotherapy ezetimibe
- Where
- 45 sites in United States
- Volunteers
- 407 people
- Sponsor
- NewAmsterdam Pharma
Homozygous Familial Hypercholesterolemia
Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia
The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- NCT04233918
- Testing
- Evinacumab
- Where
- 11 sites in United States, Australia and 4 more
- Volunteers
- 20 people
- Sponsor
- Regeneron Pharmaceuticals
Homozygous Familial Hypercholesterolemia
A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia
A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.
- Trial name
- NCT04031742
- Testing
- IBI306
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.