Clinical trials: Familial Hyperlipidemia
Heterozygous Familial Hypercholesterolemia, Elevated Cholesterol
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran.
- Trial name
- ORION-9 (NCT03397121)
- Testing
- Inclisiran
- Where
- 45 sites in United States, Canada and 6 more
- Volunteers
- 482 people
- Sponsor
- The Medicines Company
Lipoprotein Lipase Deficiency, Familial, Hyperlipoproteinemia Type I
Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia
The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and chylomicron triglyceride levels, as well as…
- Conditions
- Lipoprotein Lipase Deficiency, Familial, Hyperlipoproteinemia Type I, Chylomicronemia, Familial, Hypertriglyceridemia
- Trial name
- NCT02098278
- Testing
- CAT-2003
- Where
- 2 sites in Canada
- Volunteers
- 13 people
- Sponsor
- Catabasis Pharmaceuticals
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
Primary Hypercholesterolemia, Mixed Hyperlipidemia
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary…
- Trial name
- NCT00941603
- Testing
- SCH 900271 15mg, SCH 900271
- Volunteers
- 619 people
- Sponsor
- Merck Sharp & Dohme LLC
Familial Lipoprotein Lipase Deficiency
Safety and Efficacy in LPL-Deficient Subjects of AMT-011, an Adeno-Associated Viral Vector Expressing Human Lipoprotein Lipase [S447X]
LPLD is a rare autosomal recessive disorder, characterized by the presence of marked chylomicronemia and hence hypertriglyceridemia.
- Trial name
- NCT01109498
- Testing
- Alipogene Tiparvovec (AMT-011), Human LPL [S447X], Mycophenolate mofetil, cyclosporine
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- Amsterdam Molecular Therapeutics
Hypercholesterolemia
Safety and Tolerability Study of Ezetimibe (SCH 058235/MK-0653) Plus Atorvastatin or Simvastatin in Homozygous Familial Hypercholesterolemia (P01417/MK-0653-019)
The primary purpose of this study is to evaluate the long-term safety and tolerability of ezetimibe (SCH 058235/MK-0653) 10 mg dosed daily and co-administered with either atorvastatin or simvastatin for up to 24 months in…
- Trial name
- NCT03885921
- Testing
- Ezetimibe, Atorvastatin, Simvastatin
- Volunteers
- 44 people
- Sponsor
- Organon and Co
Hypercholesterolemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment…
- Trial name
- NCT03510715
- Testing
- Alirocumab SAR236553 (REGN727), Atorvastatin, Simvastatin
- Where
- 10 sites in Brazil, Canada and 8 more
- Volunteers
- 18 people
- Sponsor
- Sanofi
Homozygous Familial Hypercholesterolemia
Evaluate the Long-term Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
A multicenter, single arm, open label phase II clinical study evaluating the long-term efficacy and safety of SHR-1918 in homozygous familial hypercholesterolemia patients
- Trial name
- NCT07133815
- Testing
- SHR-1918
- Where
- China
- Volunteers
- 55 people
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
Heterozygous Familial Hypercholesterolemia, Coronary Artery Disease
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease…
- Trial name
- RADICHOL II (NCT00706849)
- Testing
- mipomersen sodium
- Where
- 48 sites in United States, Canada
- Volunteers
- 124 people
- Sponsor
- Kastle Therapeutics, LLC
Familial Chylomicronemia, High Risk Severe Hypertriglyceridemia (SHTG)
Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCS
This is a treatment program for the use of plozasiran in adults (AROAPOC3-EAP-002) and adolescents (AROAPOC3-EAP-003) with familial chylomicronemia syndrome (FCS) as well as in adults (AROAPOC3-EAP-004) with high risk severe…
- Trial name
- NCT06796426
- Testing
- Plozasiran
- Where
- United States
- Sponsor
- Arrowhead Pharmaceuticals
Familial Hypercholesterolemia - Homozygous
Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.
- Trial name
- NCT02173158
- Testing
- lomitapide
- Where
- 6 sites in Japan
- Volunteers
- 9 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Familial Hypercholesterolemia
Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)
The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).
- Trial name
- NCT03884452
- Testing
- Atorvastatin, Simvastatin, Ezetimibe
- Volunteers
- 50 people
- Sponsor
- Organon and Co
Hypertension, Angina Pectoris
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
In this survey, to collect the safety and efficacy information of Amlodipine /Atorvastatin (Caduet® Combination Tablets) in daily medical practice will be examined.
- Conditions
- Hypertension, Angina Pectoris, Hypercholesterolemia, Familial Hypercholesterolemia
- Trial name
- NCT01107743
- Testing
- Amlodipine/Atorvastatin
- Volunteers
- 1,291 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Lipoprotein Lipase Deficiency, Familial Hyperlipoproteinemia Type 1
Glybera Registry, Lipoprotein Lipase Deficient (LPLD) Patients
Lipoprotein lipase deficiency (LPLD) is a rare autosomal recessive disorder, characterized by loss-of function mutations in the LPL gene, leading to the inability to produce functionally active lipoprotein lipase (LPL).
- Conditions
- Lipoprotein Lipase Deficiency, Familial Hyperlipoproteinemia Type 1, Familial Hyperchylomicronemia
- Trial name
- GENIALL (NCT03293810)
- Testing
- Observational study
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- UniQure Biopharma B.V.
Hypertriglyceridemia, Familial Chylomicronemia Syndrome
Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN0361 in Adult healthy subjects and Adult Hypertriglyceridemic Subjects.
- Trial name
- NCT06471543
- Testing
- RN0361
- Where
- 10 sites in United States, Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Ikaria Bioscience Pty Ltd
Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease
A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
- Conditions
- Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Familial
- Trial name
- VICTORION-LEAP (NCT07543731)
- Where
- Switzerland
- Volunteers
- 5,995 people
- Sponsor
- Novartis Pharmaceuticals
Homozygous Familial Hypercholesterolemia
Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for reduction of low density lipoprotein cholesterol (LDL-C) levels in patients with Homozygous Familial Hypercholesterolemia (HoFH).
- Trial name
- NCT03455777
- Testing
- AKCEA-ANGPTL3-LRX
- Where
- Canada
- Sponsor
- Akcea Therapeutics
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
ASCVD, Elevated Cholesterol
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.
- Conditions
- ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
- Trial name
- ORION-8 (NCT03814187)
- Testing
- Inclisiran Sodium
- Where
- 238 sites in United States, Canada and 11 more
- Volunteers
- 3,275 people
- Sponsor
- Novartis Pharmaceuticals
Dyslipidemias, Familial Hypercholesterolemia
Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial…
- Conditions
- Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia
- Trial name
- NCT03747224
- Testing
- ARO-ANG3, sterile normal saline (0.9% NaCl)
- Where
- 6 sites in Australia, New Zealand
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals