Clinical trials: Hyperlipoproteinemia Type II
Homozygous Familial Hypercholesterolemia
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
This study will evaluate the efficacy and safety of zodasiran subcutaneous (sc) injection in participants 12 to <18 years of age with genetically or clinically diagnosed homozygous familial hypercholesterolemia (HoFH) and…
- Trial name
- SPRUCE (NCT07473843)
- Testing
- Zodasiran
- Where
- 3 sites in United States, Denmark and 1 more
- Volunteers
- 10 people
- Sponsor
- Arrowhead Pharmaceuticals
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.
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.
Type 2 Diabetes Mellitus, Hypercholesterolemia / Elevated LDL Cholesterol
Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
This Open-label, randomized clinical trial evaluates the comparative efficacy and safety of dual versus triple lipid-lowering therapy using rosuvastatin, ezetimibe, and bempedoic acid in patients with type 2 diabetes mellitus and…
- Trial name
- NCT07255820
- Testing
- Rosuvastatin + Ezetimibe, Bempedoic Acid + Ezetimibe, Rosuvastatin + Ezetimibe + Bempedoic Acid
- Where
- Pakistan
- Volunteers
- 126 people
- Sponsor
- Bahria University
Familial Hypercholesterolemia, Atherosclerosis
The Danish Familial Hypercholesterolemia Organized Coronary Screening Trial
Familial hypercholesterolemia (FH) is the most common inherited cause of atherosclerotic cardiovascular disease (ASCVD) with a prevalence of approximately one in 200 individuals, however only few of the estimated 30.000 patients…
- Trial name
- DANFOCOS (NCT05758779)
- Testing
- Visualization of coronary Imaging and oral description
- Where
- Denmark
- Volunteers
- 116 people
- Sponsor
- Odense 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
Hyperlipidemia; Mixed
Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia
Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) of single-dose ARO-DIMERPA and multiple doses of…
- Trial name
- NCT07223658
- Testing
- ARO-DIMERPA
- Where
- 19 sites in Australia, Canada and 3 more
- Volunteers
- 78 people
- Sponsor
- Arrowhead Pharmaceuticals
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
Familial Hypercholesterolaemia
Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia
The goal of this clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called Familial Hypercholesterolemia.
- Trial name
- FH-ALERT (NCT06743659)
- Testing
- Alert-based computerized decision support
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Brigham and Women's Hospital
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia.
- Trial name
- NCT05952856
- Testing
- Enlicitide Decanoate
- Where
- 168 sites in United States, Argentina and 12 more
- Volunteers
- 2,912 people
- Sponsor
- Merck Sharp & Dohme LLC
Heterozygous or Homozygous Familial Hypercholesterolemia
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 (CKJX839C12301)…
- Trial name
- V-PEDS-OLE (NCT05682378)
- Testing
- Inclisiran
- Where
- 52 sites in United States, Argentina and 24 more
- Volunteers
- 195 people
- Sponsor
- Novartis Pharmaceuticals
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
Familial Hypercholesterolaemia
The Spanish Familial Hypercholesterolaemia Cohort Study
SAFEHEART is a large, on-going registry study in molecularly defined patients with heterozygous FH treated in Spain.
- Trial name
- SAFEHEART (NCT02693548)
- Where
- Spain
- Volunteers
- 4,141 people, healthy volunteers welcome
- Sponsor
- Fundación Hipercolesterolemia Familiar
Familial Hypercholesterolemia, Cholesterol, Elevated
Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
The overall goal of this study is to promote awareness of Familial Hypercholesterolemia (FH). The investigators aim to enroll patients with suspected FH into the study and will randomize them to receive usual care or motivational…
- Conditions
- Familial Hypercholesterolemia, Cholesterol, Elevated, Genetic Disease
- Trial name
- ID-FH (NCT05238519)
- Testing
- Motivational interview (MI)
- Where
- 2 sites in United States
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- Essentia Health
Heterozygous Familial Hypercholesterolemia, Premature Coronary Heart Disease
A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease
VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease…
- Trial name
- NCT06164730
- Testing
- VERVE-102
- Where
- 27 sites in United States, Australia and 4 more
- Volunteers
- 85 people
- Sponsor
- Verve Therapeutics, Inc.
Hypercholesterolaemia, Familial Hypercholesterolaemia
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
TRAP-HC is a multicenter, observational, longitudinal, prospective study designed to evaluate real-world treatment patterns and lipid-lowering therapy (LLT) management in patients with hypercholesterolemia, including familial…
- Conditions
- Hypercholesterolaemia, Familial Hypercholesterolaemia, CVD Risk
- Trial name
- TRAP-HC (NCT07606118)
- Volunteers
- 2,500 people
- Sponsor
- Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
Familial Hypercholesterolemia
Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics
The goal of this study is to identify individuals at high risk of FH, and to encourage the appropriate diagnosis and treatment of individuals at high risk of FH through the use of implementation science and behavioral economics…
- Trial name
- BEAT FH (NCT05746247)
- Testing
- Testing centralized referral mechanism for PCPs, Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation
- Where
- United States
- Volunteers
- 610 people
- Sponsor
- University of Pennsylvania
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 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 Hypercholesterolaemia, Hypercholesterolaemia
Specified Drug-use Survey of Leqvio for s.c. Injection.
The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice
- Trial name
- NCT06275724
- Testing
- inclisiran
- Where
- 107 sites in Japan
- Volunteers
- 585 people
- Sponsor
- Novartis Pharmaceuticals