Clinical trials: Familial Hyperlipidemia
Familial Hypercholesterolemia
An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)
The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or…
- Trial name
- DICA-FH (NCT06331195)
- Testing
- Phytosterol, Krill oil
- Where
- 24 sites in Brazil
- Volunteers
- 300 people
- Sponsor
- Hospital do Coracao
Hypercholesterolemia, Hypertriglyceridemia
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia.
- Conditions
- Hypercholesterolemia, Hypertriglyceridemia, Refractory Hyperlipidemia
- Trial name
- NCT06451770
- Testing
- VERVE-201
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 132 people
- Sponsor
- Verve Therapeutics, Inc.
Hypercholesterolemia, Familial
Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®
Protein convertase subtilisin kexin type 9 (PCSK-9) inhibitors demonstrated efficacy in cholesterol reduction and in the prevention of cardiovascular events.
- Trial name
- NCT04313270
- Testing
- Evolocumab
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Federico II University
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.
Familial Hypercholesterolemia
Phase I Study of Ex Vivo Liver-Directed Gene Therapy for Familial Hypercholesterolemia
OBJECTIVES: I. Develop an approach for treating patients with homozygous familial hypercholesterolemia using gene therapy with autologous hepatocytes transduced with a normal low-density lipoprotein receptor gene.
- Trial name
- NCT00004809
- Testing
- gene therapy
- Volunteers
- 5 people
- Sponsor
- National Center for Research Resources (NCRR)
Familial Hypercholesterolemia
PMMHRI - Familial Hypercholesterolemia Registry
The registry is maintained at the Regional Centre for Rare Diseases, established in 2016, within Polish Mother's Memorial Hospital Research Institute.
- Trial name
- FH-Registry (NCT06571630)
- Where
- Poland
- Volunteers
- 300 people
- Sponsor
- Polish Mother Memorial Hospital Research Institute
Hypertriglyceridemia, Familial Chylomicronemia
Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and…
- Trial name
- NCT03783377
- Testing
- ARO-APOC3, sterile normal saline (0.9% NaCl)
- Where
- 10 sites in Australia, Canada and 1 more
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Familial Hypercholesterolemia
Atorvastatin Three Year Pediatric Study
The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial…
- Trial name
- NCT00827606
- Testing
- atorvastatin
- Where
- 40 sites in United States, Belgium and 13 more
- Volunteers
- 272 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- ODYSSEY FH I (NCT01623115)
- Testing
- Alirocumab, Lipid Modifying Therapy (LMT)
- Where
- 91 sites in United States, Austria and 12 more
- Volunteers
- 486 people
- Sponsor
- Sanofi
Cardiovascular Diseases, Coronary Disease
Genetic Epidemiology of Hypertriglyceridemia
To determine prospectively the role of elevated plasma triglyceride (TG) as a risk factor for 20-year coronary heart disease (CHD) mortality in familial combined hyperlipidemia (FCHL) and familial hypertriglyceridemia (FHTG), the…
- Conditions
- Cardiovascular Diseases, Coronary Disease, Hyperlipidemia, Familial Combined, Hyperlipoproteinemia Type iv
- Trial name
- NCT00005368
- Sponsor
- University of Washington
Hypercholesterolemia and Mixed Hyperlipidemia
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
The purpose of this study is to compare the effectiveness, safety of SYH2053 in Participants with primary hypercholesterolemia or mixed dyslipidemia. A total of 156 Participants were actually enrolled
- Trial name
- NCT07421232
- Testing
- Inclisiran (Leqvio®) 300mg
- Where
- China
- Volunteers
- 156 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Generalized Lipodystrophy
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)
This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months.
- Trial name
- NCT06548100
- Testing
- mibavademab
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Regeneron Pharmaceuticals
Homozygous Familial Hypercholesterolemia
A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH
AK102 is being developed for the treatment of HoFH. The study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of PCSK9 inhibitor AK102, and part 2 is double…
- Trial name
- NCT03933293
- Testing
- AK102, Statins, Ezetimibe
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- Akeso
Homozygous Familial Hypercholesterolemia
LOWER: Lomitapide Observational Worldwide Evaluation Registry
This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.
- Trial name
- LOWER (NCT02135705)
- Testing
- Lomitapide
- Where
- 71 sites in United States, Argentina and 6 more
- Volunteers
- 260 people
- Sponsor
- Amryt Pharma
Hypercholesterolemia, Familial Hypercholesterolemia
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with…
- Trial name
- NCT02748057
- Testing
- Ezetimibe, Rosuvastatin
- Volunteers
- 135 people
- Sponsor
- Organon and Co
Homozygous Familial Hypercholesterolemia (HoFH)
A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH)
This first-in-human study is intended to evaluate the safety and preliminary effectiveness of AAV (Adeno-associated virus)-based liver-directed gene therapy in the treatment of adults with Homozygous Familial Hypercholesterolemia…
- Trial name
- NCT02651675
- Testing
- AAV directed hLDLR gene therapy
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 9 people
- Sponsor
- REGENXBIO Inc.
Healthy, Familial Hypercholesterolemia
Postprandial Response After Intake of Meals With Different Fatty Acid Composition
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
- Trial name
- NCT02729857
- Testing
- SFA muffin, PUFA muffin
- Where
- Norway
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Oslo
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.
Heterozygous Familial Hypercholesterolaemia
Efficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care
Eprotirome is a liver selective thyroid hormone that can reduce several independent risk factors for cardiovascular disease, while an euthyroid state is preserved in the extrahepatic tissue.
- Trial name
- AKKA (NCT01410383)
- Testing
- Eprotirome
- Volunteers
- 236 people
- Sponsor
- Karo Bio AB
Familial Hypercholesterolemia
Cascade Testing In Identifying At-risk Family Members Of Individuals With Familial Hypercholesterolemia (FH) In PCP
The purpose of this study is to evaluate the effectiveness of two models of cascade testing in identifying at-risk family members of individuals diagnosed with familial hypercholesterolemia (FH).
- Trial name
- NCT07653555
- Testing
- Cascade testing, Standard of Care
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Mayo Clinic