Clinical trials: Hypercholesterolemia, Autosomal Dominant
Heterozygous Familial Hypercholesterolemia
Safety and Efficacy of IBI306 in HeFH Patients
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R…
- Trial name
- NCT04179669
- Testing
- IBI306
- Where
- China
- Volunteers
- 149 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Familial Hypercholesterolemia, Cardiac Event
Detection of Familial Hypercholesterolaemia in Cardiovascular Disease Registry
Familial hypercholesterolaemia (FH) is an autosomal dominant somatic mutation commonly located on the LDL-receptor, APOB, and PCKS9 gene.
- Conditions
- Familial Hypercholesterolemia, Cardiac Event, Percutaneous Coronary Intervention
- Trial name
- NCT02778646
- Volunteers
- 1,622,948 people
- Sponsor
- University College, London
Homozygous Familial Hypercholesterolemia
Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- NCT02265952
- Testing
- REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 9 people
- Sponsor
- Regeneron Pharmaceuticals
Atherosclerosis, Heterozygous Familial Hypercholesterolemia
Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE.
The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.
- Trial name
- NCT00151788
- Testing
- Pactimibe sulfate
- Where
- 37 sites in United States, Canada and 7 more
- Volunteers
- 796 people
- Sponsor
- Daiichi Sankyo
Familial Hypercholesterolemia
Effects of LDL Apheresis System on the Expression of Genes Involved in Lipoprotein Metabolism and Inflammation in Homozygotes for Familial Hypercholesterolemia
Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by mutations in the LDL receptor gene that disrupt the normal clearance of LDL particles from the plasma compartment.
- Trial name
- LA-PBMC (NCT02462655)
- Testing
- Pre-lipid apheresis, Post-lipid apheresis
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- Laval University
Hypercholesterolemia
Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)
This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial…
- Trial name
- NCT00129402
- Testing
- ezetimibe with simvastatin, simvastatin
- Volunteers
- 248 people
- Sponsor
- Organon and Co
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Vytorin Reexamination Study (0653A-174)
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting…
- Trial name
- NCT01070966
- Volunteers
- 2,089 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Familial
Screening Protocol for a Gene Therapy Trial in Subjects With Homozygous Familial Hypercholesterolemia
The purpose of this protocol is to identify and screen potential candidates for future enrollment in a gene therapy clinical trial for HoFH.
- Trial name
- NCT03018678
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Pennsylvania
Hypercholesterolemia, LDL Cholesterol
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.
- Trial name
- NCT01859455
- Testing
- LGT209 50 mg, LGT209 300 mg, Statins (atorvastatin or simvastatin)
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Atherosclerotic Cardiovascular Diseases
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current…
- Trial name
- NCT02666664
- Testing
- ETC-1002
- Where
- 104 sites in United States, Canada and 4 more
- Volunteers
- 2,230 people
- Sponsor
- Esperion Therapeutics, Inc.
Heterozygous Familial Hypercholesterolemia
Lp(a) and Aortic Valve Calcification
Aortic valve stenosis (AVS), the most common form of valve disease in the western world, afflicts more than 1 million individuals in North America [1] and the burden of AVS is high and is expected to double within the next 50…
- Trial name
- FHLPA (NCT02976818)
- Where
- Canada
- Volunteers
- 173 people
- Sponsor
- Laval University
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
Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome
Pediatric Reporting of Adult-Onset Genomic Results
The Investigators will conduct a longitudinal, mixed-methods cohort study to assess primary and secondary psychosocial outcomes among MyCode adolescent participants and their parents, and health behaviors of children who received…
- Conditions
- Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome, Familial Hypercholesterolemia
- Trial name
- NCT03832985
- Testing
- Child(ren) receive an adult-onset result, Child(ren) received a pediatric-onset result, Control - Negative Result
- Where
- United States
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Geisinger Clinic
Homozygous Familial Hypercholesterolemia
NGGT006 Gene Therapy for Homozygous Familial Hypercholesterolemia
This is an early phase 1, open-label, single-center, dose-escalation, pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in homozygous familial hypercholesterolemia (HoFH) patients with LDLR…
- Trial name
- NCT06125847
- Testing
- NGGT006
- Where
- China
- Volunteers
- 21 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
Long Term Safety Study of PRALUENT
The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very…
- Trial name
- NCT03694197
- Testing
- Praluent
- Where
- 123 sites in United States, Bulgaria and 4 more
- Volunteers
- 1,389 people
- Sponsor
- Regeneron Pharmaceuticals
Familial Hypercholesterolemias, Atherosclerotic Cardiovascular Disease (ASCVD)
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
The goal of this study (interventional clinical research not involving a health product) is to assess the prevalence of subclinical coronary atherosclerosis diagnosed by coronary CT angiography in heart failure patients in…
- Trial name
- ATHERO-FH (NCT06960902)
- Testing
- Coronary CT scan with CAC score measurement
- Where
- 9 sites in France
- Volunteers
- 600 people
- Sponsor
- Nantes University Hospital
Heterozygous Familial Hypercholesterolemia
A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower…
- Trial name
- SPIRE-FH (NCT01968980)
- Testing
- Bococizumab (PF-04950615;RN316)
- Where
- 88 sites in United States, Bulgaria and 9 more
- Volunteers
- 370 people
- Sponsor
- Pfizer
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
Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH)
The ORIGIN-FH Study
The goal of this clinical trial is to identify different types of Familial Hypercholesterolemia (FH) in infants and newborns. Participants will: undergo a cheek swab for genetic testing (parents only) have 5 blood samples…
- Conditions
- Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH), Familial Hypercholesterolemia
- Trial name
- ORIGIN-FH (NCT07470723)
- Testing
- Screening for FH
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of Wisconsin, Madison
Heterozygous Familial Hypercholesterolemia
Early-phase Study of ART002g1 Injection in HeFH: Safety, Tolerability and Preliminary Efficacy
This study is an open-label, single ascending dose (SAD) study designed to evaluate the safety and tolerability of ART002g1 in patients with heterozygous familial hypercholesterolemia (HeFH) who require further reduction in…
- Trial name
- NCT07353398
- Testing
- ART002g1 Injection
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine