Clinical trials: Heterozygous Familial Hypercholesterolemia
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.
Heterozygous Familial Hypercholesterolemia
A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).
JS002 is a recombinant human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia…
- Trial name
- NCT05325203
- Testing
- Ongericimab
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Familial Hypercholesterolemia, Nutrition, Healthy
Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia.
The investigators will conduct a fully controlled dietary randomized crossover trial (RCT) including 10 adults with HeFH using lipid-lowering medication to investigate the impact of a diet low in red and processed meats and high…
- Conditions
- Familial Hypercholesterolemia, Nutrition, Healthy, Cholesterol, Elevated
- Trial name
- NCT06389825
- Testing
- Healthy diet
- Where
- Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Laval University
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
- Trial name
- NCT03067441
- Testing
- bempedoic acid
- Where
- 3 sites in United States
- Volunteers
- 1,462 people
- Sponsor
- Esperion Therapeutics, Inc.
Dyslipidaemia
48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety
The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.
- Trial name
- NCT00654602
- Testing
- Rosuvastatin, Maintenance of specific diet
- Volunteers
- 1,500 people
- Sponsor
- AstraZeneca
Atherosclerosis, Cardiovascular Disease
A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
The purpose of this study is to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to placebo in adults who have plaque buildup in their arteries or are at high risk of developing it.
- Conditions
- Atherosclerosis, Cardiovascular Disease, Hypercholesterolemia
- Trial name
- HEART-3 (NCT07839936)
- Testing
- VERVE-102
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- Verve Therapeutics, Inc.
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)
This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with…
- Trial name
- NCT02460159
- Testing
- EZ 10 mg/Atorva 20 mg FDC, EZ 10 mg/Atorva 10 mg FDC
- Volunteers
- 135 people
- Sponsor
- Organon and Co
Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B
Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia
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…
- Conditions
- Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B, Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation, Familial Hypercholesterolemia - Heterozygous
- Trial name
- ACCURATE (NCT05218005)
- Testing
- Research-based genetic test for Familial Hypercholesterolemia
- Where
- 2 sites in Canada
- Volunteers
- 140 people
- Sponsor
- University of British Columbia
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
Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with…
- Trial name
- ODYSSEY FH II (NCT01709500)
- Testing
- LMT (atorvastatin, simvastatin, or rosuvastatin), alirocumab
- Where
- 24 sites in Czechia, Netherlands and 2 more
- Volunteers
- 249 people
- Sponsor
- Regeneron Pharmaceuticals
Pediatric Heterozygous Hypercholesterolemia
8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia
- Trial name
- NCT00739999
- Testing
- Atorvastatin
- Where
- 3 sites in Canada, Greece and 1 more
- Volunteers
- 39 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial…
- Trial name
- NCT01583647
- Testing
- MK-0524A
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC
Dyslipidemias, High Cholesterol
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
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…
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia
- Trial name
- BROOKLYN (NCT05425745)
- Testing
- Obicetrapib
- Where
- 96 sites in United States, Canada and 8 more
- Volunteers
- 354 people
- Sponsor
- NewAmsterdam Pharma
Heterozygous Familial Hypercholesterolemia (HeFH)
Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia
The goal is to assess the long term efficacy (LDL cholesterol reduction) and safety over 3 years of lerodalcibep (Lerochol) SC 300 mg QM administered by auto-injector (AI)/pre-filled pen (PFP) in male and female pediatric…
- Trial name
- NCT07775339
- Testing
- Lerodalcibep
- Where
- 5 sites in India, Israel and 3 more
- Volunteers
- 150 people
- Sponsor
- LIB Therapeutics LLC
Familial Hypercholesterolemia - Heterozygous
Study of Coronary Calcification in Subjects With Autosomal Dominant Familial Hypercholesterolemia Heterozygous
Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder characterized by elevated plasma levels of LDL-C cholesterol.
- Trial name
- FH-CALC (NCT03501875)
- Testing
- CAC Score
- Where
- France
- Volunteers
- 270 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Fredrickson Type IIa & Type IIb Dyslipidaemia
IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa \& Type IIb Dyslipidaemia
- Trial name
- NCT00654446
- Testing
- Rosuvastatin, Simvastatin
- Volunteers
- 442 people
- Sponsor
- AstraZeneca
Hypercholesterolemia, Familial
Study of ISIS 301012 (Mipomersen) in Heterozygous 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 (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia
- Trial name
- NCT00281008
- Where
- 8 sites in United States, Netherlands
- Volunteers
- 44 people
- Sponsor
- Kastle Therapeutics, LLC
Hypercholesterolemia, Heterozygous Familial
A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein…
- Trial name
- FOCUS FH (NCT01475825)
- Testing
- mipomersen sodium 200 mg, mipomersen sodium 70 mg
- Where
- 113 sites in United States, Argentina and 28 more
- Volunteers
- 309 people
- Sponsor
- Kastle Therapeutics, LLC
Heterozygous Familial Hypercholesterolemia (HeFH)
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
A phase 1/2, two-part trial consisting of an open label dose-escalation part and a randomized, double blind, placebo-controlled part to investigate safety, tolerability, pharmacokinetics, and efficacy with EDIT-401 gene editing…
- Trial name
- NCT07894887
- Testing
- Drug: EDIT-401
- Where
- 2 sites in Australia
- Volunteers
- 56 people
- Sponsor
- Editas Medicine, Inc.
Heterozygous Familial Hypercholesterolemia
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with…
- Trial name
- ODYSSEY ESCAPE (NCT02326220)
- Testing
- Alirocumab
- Where
- 13 sites in United States, Germany
- Volunteers
- 62 people
- Sponsor
- Regeneron Pharmaceuticals