Clinical trials: Familial Hypercholesterolemia, active
Homozygous Familial Hypercholesterolemia (HoFH), Coronary Computed Tomography Angiography
Assessing the Impact of Intensification of Lipid Lowering Therapy With Guidelines-based Evinacumab Administration on Coronary Plaque Volumes Measured by Coronary Computed Tomography Angiography (CCTA) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
This observational, multicenter, retrospective and prospective study aims to evaluate the impact of intensified lipid-lowering therapy including Evinacumab on coronary atherosclerotic plaque burden in patients with Homozygous…
- Trial name
- EVOLVE-HoFH (NCT07447648)
- Where
- 13 sites in France, Italy and 2 more
- Volunteers
- 52 people
- Sponsor
- Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
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 Hypercholesterolaemia
A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH
This is a study to evaluate the efficacy and safety of AZD0780 in adults with HeFH and elevated LDL-C, either with clinical ASCVD and LDL-C levels of 55 mg/dL or higher or without clinical ASCVD and LDL-C levels of 70 mg/dL or…
- Trial name
- AZURE-HeFH (NCT07000136)
- Testing
- AZD0780
- Where
- 133 sites in United States, Argentina and 22 more
- Volunteers
- 473 people
- Sponsor
- AstraZeneca
Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
This is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of IBI306 monotherapy in Chinese Paricipants with non-familial hypercholesterolemia and mixed…
- Trial name
- NCT07473960
- Testing
- IBI306
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
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
Hypercholesterolemia, Familial, Clinical Decision Support
Clinical Decision Support for Familial Hypercholesterolemia
A cluster randomized study in the primary care setting to evaluate a computer-based clinical decision support system to aid in the identification and management of patients with FH.
- Trial name
- CDS-FH (NCT03989167)
- Testing
- Clinical decision support
- Where
- Sweden
- Volunteers
- 472,029 people
- Sponsor
- University Hospital, Linkoeping
Familial Hypercholesterolemia
Child-Parent Familial Hypercholesterolemia Screening
Child-parent screening for familial hypercholesterolemia has been proposed to identify children and their parent who are carrier of mutations and with high risk for inherited premature coronary artery disease.
- Trial name
- NCT04529967
- Testing
- no interventions
- Where
- 6 sites in China
- Volunteers
- 15,000 people
- Sponsor
- Children's Hospital of Fudan University
Lipid Metabolism Disorder
Multicomponent Intervention Study- Blood Donors With High Cholesterol
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).
- Trial name
- DONATE-FH (NCT05693701)
- Testing
- Implementation Strategy Bundle, Usual care notification
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Texas Southwestern Medical Center
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.
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.
Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy
The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.
- Trial name
- NCT07421284
- Where
- China
- Volunteers
- 900 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH
The goal of this clinical trial is to assess the LDL-Cholesterol reductions at Week 12 and Week 24 with monthly dosing of lerodalcibep (Lerochol) 300 mg administered subcutaneously by auto-injector (AI)/pre-filled pen (PFP)…
- Trial name
- LIBerateKids (NCT07102511)
- Testing
- lerodalcibep 300 mg Monthly SC
- Where
- 7 sites in United States, Israel and 4 more
- Volunteers
- 150 people
- Sponsor
- LIB Therapeutics LLC
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.
Diagnosed With HoFH
Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2070 Injection in Participants With Homozygous Familial Hypercholesterolemia
This trial is a multicenter, open-label, phase II clinical study, aiming to evaluate the efficacy and safety of SYH2070 injection in participants with HoFH.
- Trial name
- NCT07591298
- Testing
- SYH2070 injection dose1, SYH2070 injection dose2
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolemia
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH.
- Trial name
- NCT04941599
- Testing
- 2-Hydroxybenzylamine
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Vanderbilt University Medical Center
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
Familial Hypercholesterolemia
Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia
The study aims to investigate the effects of breastfeeding on lipid profile and cardiovascular risk markers in women with familial hypercholesterolemia (FH) compared to women without FH.
- Trial name
- FH-FEMINA (NCT05367310)
- Where
- 4 sites in Czechia, Netherlands and 1 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Oslo University Hospital
Homozygous Familial Hypercholesterolemia
A Phase 3 Study of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE)
This multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of zodasiran subcutaneous (SC) injection in subjects 12 years of age and older with genetically or clinically diagnosed Homozygous…
- Trial name
- NCT07037771
- Testing
- zodasiran Injection
- Where
- 43 sites in United States, Australia and 16 more
- Volunteers
- 70 people
- Sponsor
- Arrowhead Pharmaceuticals
Familial Hypercholesterolemia
Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
Diagnosis rates of familial hypercholesterolemia (FH) are low in the United States, despite multiple guidelines and recommendations for screening and treatment of high cholesterol, to prevent heart attacks in those affected.
- Trial name
- CARE-FH (NCT05284513)
- Testing
- FH diagnosis program, Implementation strategy package: Develop and implement tools for quality monitoring, Implementation strategy package: Develop educational materials
- Where
- United States
- Volunteers
- 532 people
- Sponsor
- Geisinger Clinic