Rare hypercholesterolemia

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ORPHA:477811
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28Active trials8Treatment centers

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Overview

Rare hypercholesterolemia refers to unusually high levels of cholesterol in the blood that are caused by rare genetic conditions. Unlike the more common forms of high cholesterol that are linked to diet and lifestyle, rare hypercholesterolemia is driven by inherited changes in genes that control how the body processes and removes cholesterol. The most well-known form is Familial Hypercholesterolemia (FH), but this Orphanet category also covers other rare genetic causes of severely elevated cholesterol. When cholesterol builds up in the blood over time, it can deposit in the walls of arteries, causing them to narrow and harden. This raises the risk of heart attack and stroke, sometimes at a very young age. People may also develop yellowish fatty deposits called xanthomas on their skin or tendons, and cholesterol rings around the eyes called corneal arcus. Some people have no obvious symptoms until a serious heart event occurs. Treatment usually involves a combination of cholesterol-lowering medications such as statins, ezetimibe, and newer drugs like PCSK9 inhibitors (for example, evolocumab and alirocumab). In the most severe cases, a procedure called LDL apheresis — which filters cholesterol from the blood — may be needed. Early diagnosis and treatment are very important to reduce the risk of heart disease.

Key symptoms:

Very high LDL ('bad') cholesterol levels in blood testsYellowish fatty skin deposits (xanthomas) on elbows, knees, or handsFatty deposits on tendons, especially the Achilles tendonYellowish deposits around the eyelids (xanthelasmas)Grayish-white ring around the colored part of the eye (corneal arcus)Chest pain or angina, especially with exertionHeart attack, sometimes at a young ageStroke or mini-stroke (TIA)Narrowing of heart arteries (coronary artery disease)Family history of early heart disease

Inheritance

Variable

Can be inherited in different ways depending on the underlying gene

Age of Onset

Variable

Can begin at different ages, from infancy through adulthood

Orphanet ↗NORD ↗

FDA & Trial Timeline

10 events
May 2026QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

Qilu Pharmaceutical Co., Ltd. — PHASE3

TrialNOT YET RECRUITING
Apr 2026"Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)"

Assistance Publique - Hôpitaux de Paris — NA

TrialNOT YET RECRUITING
Mar 2026A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. — PHASE3

TrialNOT YET RECRUITING
Mar 2026Early-phase Study of ART002g1 Injection in HeFH: Safety, Tolerability and Preliminary Efficacy

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine — EARLY_PHASE1

TrialNOT YET RECRUITING
Feb 2026The ORIGIN-FH Study

University of Wisconsin, Madison — NA

TrialRECRUITING
Sep 2025Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)

Nantes University Hospital — NA

TrialRECRUITING
Sep 2025Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH

LIB Therapeutics LLC — PHASE3

TrialNOT YET RECRUITING
Aug 2025A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Merck Sharp & Dohme LLC — PHASE2, PHASE3

TrialRECRUITING
Jun 2025Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study

Novartis Pharmaceuticals

TrialRECRUITING
Apr 2025Child-Parent Familial Hypercholesterolemia Screening

Children's Hospital of Fudan University

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Rare hypercholesterolemia.

20 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

20 recruitingView all trials with filters →
Phase 33 trials
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
Phase 3
Enrolling by Invitation
PI: David Kallend, MB BCh (LIB Therapeutics) · Sites: Evanston, Illinois; Cincinnati, Ohio +10 more · Age: 1099 yrs
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
Phase 3
Actively Recruiting
PI: Novartis Pharmaceuticals (Novartis Pharmaceuticals) · Sites: San Francisco, California; San Francisco, California +16 more · Age: 211 yrs
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
Phase 3
Actively Recruiting
PI: Novartis Pharmaceuticals (Novartis Pharmaceuticals) · Sites: San Francisco, California; San Francisco, California +64 more · Age: 611 yrs
Phase 21 trial
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
Phase 2
Actively Recruiting
PI: MacRae F. Linton, MD (Vanderbilt University Medical Center) · Sites: Nashville, Tennessee · Age: 1869 yrs
Phase 11 trial
A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease
Phase 1
Actively Recruiting
· Sites: Dothan, Alabama; Pomona, California +19 more · Age: 1870 yrs
N/A2 trials
The Danish Familial Hypercholesterolemia Organized Coronary Screening Trial
N/A
Active
PI: Finn Lund Henriksen, PhD (Odense University Hospital) · Sites: Odense · Age: 2070 yrs
Atlantic Lipid Lowering Treatment Optimization Program
N/A
Actively Recruiting
PI: Robert D Fishberg, MD (Atlantic Health System) · Sites: Clark, New Jersey; Springfield, New Jersey · Age: 18120 yrs
Other12 trials
Lipid Transport Disorder Italian Genetic Record (LIPIGEN)
Actively Recruiting
PI: Alberico L Catapano, PhD (Fondazione S.I.S.A.) · Sites: Sesto San Giovanni, Milano
EAS Familial Hypercholesterolaemia Studies Collaboration
Actively Recruiting
PI: Kausik Ray, MD MPhil (Imperial College London) · Sites: London
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Actively Recruiting
· Sites: Angers; Nantes +1 more · Age: 3599 yrs
Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia
Active
PI: Kirsten Holven, PhD (Oslo University Hospital) · Sites: Brno; Prague +2 more · Age: 1899 yrs
Child-Parent Familial Hypercholesterolemia Screening
Actively Recruiting
PI: LIling Qian, Master (Children's Hospital of Fudan University) · Sites: Hefei, Anhui; Qidong, Jiangsu +4 more · Age: 13 yrs
Genetic Causes of Familial Hypercholesterolemia
Active
PI: Anna M Nordenskjöld, MD, PhD (Örebro University, Sweden) · Sites: Örebro · Age: 899 yrs
Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada
Actively Recruiting
PI: Jacques Genest, MD (Research Institute of the McGill University Health) · Sites: Montreal, Quebec
Long-term Follow-up of Participants Dosed with an Investigational Gene Editing Therapy for Cardiovascular Disease
Enrolling by Invitation
· Sites: Auckland; Christchurch +1 more · Age: 1899 yrs
Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia
Enrolling by Invitation
PI: Jonas Brinck, MD PhD (Dept. of Medicine Huddinge H7, Karolinska Institut) · Sites: Stockholm
Russian Familial Hypercholesterolemia Registry
Actively Recruiting
PI: Valery Kukharchuk, MD, DMSc (Russian Cardiology Research and Production Center) · Sites: Chelyabinsk; Moscow +3 more · Age: 780 yrs
Early Detection of Familial Hypercholesterolemia in Children
Actively Recruiting
PI: Luis Masana, MD, PhD (Institut Investigacio Sanitaria Pere Virgili) · Sites: Reus, Tarragona; Reus, Tarragona · Age: 218 yrs
Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
Actively Recruiting
· Sites: Cadiz, Andalusia; Granada, Andalusia +17 more · Age: 1899 yrs

No specialists are currently listed for Rare hypercholesterolemia.

View NORD Rare Disease Centers ↗Undiagnosed Disease Network ↗

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Rare hypercholesterolemia.

Search all travel grants →NORD Financial Assistance ↗

Community

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Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.Which specific gene is causing my high cholesterol, and what does that mean for my treatment?,At what LDL level should I start medication, and which medication is right for me?,Should my children or siblings be tested for this condition?,How often do I need heart monitoring, such as stress tests or imaging?,Are there newer treatments like PCSK9 inhibitors or gene therapy that I should consider?,What lifestyle changes will make the biggest difference alongside my medication?,What are the warning signs I should watch for that would require emergency care?

Common questions about Rare hypercholesterolemia

What is Rare hypercholesterolemia?

Rare hypercholesterolemia refers to unusually high levels of cholesterol in the blood that are caused by rare genetic conditions. Unlike the more common forms of high cholesterol that are linked to diet and lifestyle, rare hypercholesterolemia is driven by inherited changes in genes that control how the body processes and removes cholesterol. The most well-known form is Familial Hypercholesterolemia (FH), but this Orphanet category also covers other rare genetic causes of severely elevated cholesterol. When cholesterol builds up in the blood over time, it can deposit in the walls of arteries,

Are there clinical trials for Rare hypercholesterolemia?

Yes — 20 recruiting clinical trials are currently listed for Rare hypercholesterolemia on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.