Clinical trials: Heterozygous Familial Hypercholesterolemia
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
Hypercholesterolemia
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.
- Trial name
- CLEAR Path 1 (NCT05694260)
- Testing
- Bempedoic acid
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 31 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia.
- Trial name
- NCT05952869
- Testing
- Enlicitide Decanoate
- Where
- 59 sites in United States, Australia and 15 more
- Volunteers
- 303 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia, Familial, Hyperlipidemia
Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with heterozygous familial…
- Trial name
- RADIANCE 1 (NCT00136981)
- Testing
- torcetrapib/atorvastatin, atorvastatin
- Where
- 34 sites in United States, Canada and 6 more
- Volunteers
- 800 people
- Sponsor
- Pfizer
Hypercholesterolemia
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin…
- Trial name
- NCT00145574
- Testing
- colesevelam HCl
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 194 people
- Sponsor
- Daiichi Sankyo
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
Heterozygous Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease
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…
- Conditions
- Heterozygous Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia
- Trial name
- NCT05398029
- Testing
- VERVE-101
- Where
- 3 sites in New Zealand, United Kingdom
- Volunteers
- 13 people
- Sponsor
- Verve Therapeutics, Inc.
Primary Hypercholesterolemia
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years…
- Trial name
- NCT00867165
- Testing
- ezetimibe
- Volunteers
- 138 people
- Sponsor
- Organon and Co
Heterozygous Familial Hypercholesterolemia
Effects of Soy Protein on Cholesterol Levels in Children Affected With Familial Hypercholesterolemia
Familial hypercholesterolemia (FH) is an inheritable, autosomal dominant disorder leading to pathologically increased levels of low-density-lipoprotein cholesterol (LDL-C).
- Trial name
- SOYFIT (NCT03563547)
- Testing
- Dietary counseling (fat modifed diet), Dietary Counseling (fat modified + soy enriched diet)
- Where
- Austria
- Volunteers
- 34 people
- Sponsor
- Austrian Academic Institute for Clinical Nutrition
Heterozygous Familial Hypercholesterolemia (HeFH)
QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 Treatment in adults with Heterozygous Familial Hypercholesterolemia on a stable lipid-lowering therapy.
- Trial name
- NCT07450378
- Testing
- QLC7401 Injection
- Volunteers
- 120 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hypercholesterolaemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels…
- Trial name
- NCT03510884
- Testing
- Alirocumab SAR236553 (REGN727), Rosuvastatin, Atorvastatin
- Where
- 43 sites in United States, Argentina and 22 more
- Volunteers
- 153 people
- Sponsor
- Sanofi
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
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
Hypercholesterolemia, Familial
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima…
- Trial name
- ACHIEVE (NCT00384293)
- Testing
- Comparator: niacin (+) laropiprant (MK0524A)
- Volunteers
- 937 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hyperlipidemias
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol…
- Trial name
- NCT03337308
- Testing
- Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid, Ezetimibe
- Where
- 5 sites in United States
- Volunteers
- 382 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolemia, Dyslipidemias
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W [≤31 days]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic…
- Conditions
- Hypercholesterolemia, Dyslipidemias, Primary Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
- Trial name
- NCT06568471
- Testing
- Lerodalcibep
- Where
- 18 sites in China
- Volunteers
- 210 people
- Sponsor
- Hasten Biopharmaceutical Co., Ltd.
Familial Hypercholesterolemia
Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients…
- Trial name
- NCT00079859
- Testing
- Implitapide
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 120 people
- Sponsor
- Medical Research Laboratories International
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
The purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or…
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- NCT00477594
- Testing
- mipomersen sodium
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Kastle Therapeutics, LLC
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with…
- Trial name
- ORION-15 (NCT04666298)
- Testing
- Inclisiran sodium
- Where
- 42 sites in Japan
- Volunteers
- 312 people
- Sponsor
- Novartis Pharmaceuticals
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