Homozygous familial hypercholesterolemia

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ORPHA:391665OMIM:143890E78.0
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7FDA treatments14Active trials29Specialists8Treatment centers5Financial resources

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Overview

Homozygous familial hypercholesterolemia (HoFH) is a rare and serious genetic condition that causes extremely high levels of LDL cholesterol — often called "bad cholesterol" — in the blood from birth. It is also sometimes referred to as homozygous FH. In this condition, a person inherits two copies of a faulty gene (one from each parent), which means the body's ability to remove LDL cholesterol from the blood is severely impaired or completely absent. As a result, cholesterol builds up in the walls of arteries at a very young age, leading to a condition called atherosclerosis (hardening and narrowing of the arteries). People with HoFH typically have LDL cholesterol levels above 500 mg/dL (sometimes exceeding 1,000 mg/dL), which is roughly five to ten times higher than normal. Visible signs can appear in childhood, including yellowish fatty deposits under the skin (xanthomas), especially on the hands, elbows, knees, and Achilles tendons, as well as a grayish-white ring around the cornea of the eye (corneal arcus). Without treatment, heart attacks and severe cardiovascular disease can occur in childhood or the teenage years. The treatment landscape for HoFH has expanded significantly in recent years. Traditional cholesterol-lowering medications like statins are used but are often not enough on their own. Newer therapies include lomitapide, evinacumab, and PCSK9 inhibitors. A procedure called LDL apheresis, which physically filters cholesterol from the blood (similar to dialysis), is a cornerstone of treatment. Liver transplantation has also been performed in severe cases. Early and aggressive treatment is essential to prevent life-threatening cardiovascular events.

Also known as:

Key symptoms:

Extremely high cholesterol levels from birthYellowish fatty bumps on the skin (xanthomas), especially on hands, elbows, knees, and tendonsFatty deposits on the Achilles tendonGray or white ring around the colored part of the eye (corneal arcus)Chest pain or angina at a young ageHeart attack in childhood, teens, or young adulthoodNarrowing of the aortic valve (aortic stenosis)Shortness of breath with exertionFatty deposits around the eyelids (xanthelasma)Fatigue or reduced exercise toleranceBlockages in arteries throughout the body

Clinical phenotype terms (33)— hover any for plain English
Increased LDL cholesterol concentrationHP:0003141Precocious atherosclerosisHP:0004416Premature arteriosclerosisHP:0005177Coronary artery atherosclerosisHP:0001677Renal artery stenosisHP:0001920Peripheral arterial stenosisHP:0004950Abnormal left ventricular functionHP:0005162Premature coronary artery atherosclerosisHP:0005181Myocardial steatosisHP:0006693Cerebral artery atherosclerosisHP:0007201Aortic atherosclerotic lesionHP:0012397
Inheritance

Autosomal recessive

Passed on when both parents carry the same gene change; often skips generations

Age of Onset

Childhood

Begins in childhood, roughly ages 1 to 12

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
Mar 2026Assessing 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)

Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)

TrialNOT YET RECRUITING
Mar 2026Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia

Arrowhead Pharmaceuticals — PHASE3

TrialNOT YET RECRUITING
Feb 2026JUXTAPID: New indication approved
FDAcompleted
Feb 2026LEQVIO: New indication approved
FDAcompleted
Feb 2026A Dose-exploration Study of EDP167 in HoFH

Eddingpharm (Zhuhai) Co., Ltd. — PHASE2

TrialRECRUITING
Aug 2025Evaluate the Long-term Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

Beijing Suncadia Pharmaceuticals Co., Ltd — PHASE2

TrialNOT YET RECRUITING
Jun 2025A Phase 3 Study of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE)

Arrowhead Pharmaceuticals — PHASE3

TrialRECRUITING
Apr 2025Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia

Brigham and Women's Hospital — NA

TrialRECRUITING
Dec 2024A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of VSA003 in Chinese HoFH Patients

Visirna Therapeutics HK Limited — PHASE3

TrialNOT YET RECRUITING
Sep 2024Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia

Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)

TrialACTIVE NOT RECRUITING

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

Treatments

7 available

Leqvio

inclisiran· Novartis Pharmaceuticals CorporationOrphan Drug

as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH)

Praluent

alirocumab· Regeneron Pharmaceuticals, Inc.Orphan Drug

as an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in adults with homozygous familial hypercholesterolemia (HoFH)

Evkeeza

evinacumab-dgnb· Regeneron Pharmaceuticals, Inc.Orphan Drug
as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholester

as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (HoFH)

Crestor

rosuvastatin· iPR Pharmaceuticals, Inc.Orphan Drug
An adjunct to diet to reduce LDL-C, Total-C, nonHDL-C and ApoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering

An adjunct to diet to reduce LDL-C, Total-C, nonHDL-C and ApoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis).

Repatha

evolocumab· Amgen Inc.Orphan Drug

As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with HoFH who require additional lowering of LDL-C.

KYNAMRO

mipomersen· Kastle Therapeutics, LLCOrphan Drug
Adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (no

Adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Juxtapid

lomitapide· Chiesi Farmaceutici S.p.A.■ Boxed WarningOrphan Drug
Adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B

Adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Clinical Trials

14 recruitingView all trials with filters →
Phase 33 trials
A Phase 3 Study of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE)
Phase 3
Actively Recruiting
· Sites: Park Ridge, Illinois; New York, New York +20 more · Age: 1299 yrs
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
Phase 3
Active
PI: Novartis Pharmaceuticals (Novartis Pharmaceuticals) · Sites: Boca Raton, Florida; New York, New York +50 more · Age: 12100 yrs
Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
Phase 3
Active
· Sites: Duluth, Minnesota; Duluth, Minnesota · Age: 275 yrs
Phase 22 trials
Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH)
Phase 2
Active
· Sites: Mount Sinai, New York; Cincinnati, Ohio +5 more · Age: 1699 yrs
A Dose-exploration Study of EDP167 in HoFH
Phase 2
Actively Recruiting
PI: Kefei Dou, MD (Chinese Academy of Medical Sciences, Fuwai Hospita) · Sites: Beijing · Age: 1899 yrs
N/A2 trials
PMMHRI - Familial Hypercholesterolemia Registry
N/A
Actively Recruiting
PI: Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA · Sites: Lodz · Age: 199 yrs
Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia
N/A
Actively Recruiting
· Sites: Boston, Massachusetts
Other5 trials
HoFH, the International Clinical Collaborators Registry
Actively Recruiting
PI: Marina Cuchel, MD, PhD (University of Pennsylvania) · Sites: Philadelphia, Pennsylvania; Amsterdam +2 more
LOWER: Lomitapide Observational Worldwide Evaluation Registry
Actively Recruiting
PI: Janet Boylan (Amryt Pharmaceuticals) · Sites: Birmingham, Alabama; Mobile, Alabama +73 more
The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository
Actively Recruiting
PI: Lisa C. Hudgins, M.D. (The Rogosin Institute) · Sites: New York, New York
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Active
· Sites: Lille; Lyon +28 more · Age: 1899 yrs
Specified Drug-use Survey of Leqvio for s.c. Injection.
Active
PI: Novartis Pharmaceuticals (Novartis Pharmaceuticals) · Sites: Handa, Aichi-ken; Ichinomiya, Aichi-ken +105 more · Age: 15100 yrs

Specialists

Showing 25 of 29View all specialists →
PP
Patrick Couture, MD, FRCP, PhD
NASHVILLE, TN
Specialist
PI on 3 active trials
DM
Dan J Rader, MD
PHILADELPHIA, PA
Specialist
PI on 1 active trial
EP
Evan A Stein, MD PhD
CHICAGO, IL
Specialist
PI on 1 active trial
MM
Mark Sumeray, MD
Specialist
PI on 1 active trial
SM
Scott Wright, MD
Specialist
PI on 1 active trial
RM
Robert D Shamburek, M.D.
Specialist
PI on 4 active trials
LM
Lisa C. Hudgins, M.D.
Specialist
PI on 1 active trial
AM
Amy Peterson, MD, MS
Specialist
PI on 1 active trial
SD
Shuiping Zhao, Doctor
Specialist
PI on 1 active trial
MP
Mariko Harada-Shiba, M.D., Ph.D.
Specialist
PI on 1 active trial
DP
David Pittrow, MD, PhD
Specialist
PI on 3 active trials
BP
Bertrand CARIOU, Pr
Dijon
Specialist

Rare Disease Specialist

MM
Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA
Lodz
Specialist

Rare Disease Specialist

RP
Robert Pordy
NEW YORK, NY
Specialist
3 Homozygous familial hypercholesterolemia publications
MG
Marco Gentile
SAN ANTONIO, TX
Specialist
3 Homozygous familial hypercholesterolemia publications
FR
Frederick J Raal
Specialist
5 Homozygous familial hypercholesterolemia publications
DB
Dirk J Blom
Specialist
4 Homozygous familial hypercholesterolemia publications
HT
Hayato Tada
Specialist
3 Homozygous familial hypercholesterolemia publications
AW
Albert Wiegman
Specialist
3 Homozygous familial hypercholesterolemia publications
MT
Maria Donata Di Taranto
Specialist
3 Homozygous familial hypercholesterolemia publications
GI
Gabriella Iannuzzo
Specialist
3 Homozygous familial hypercholesterolemia publications
GF
Giuliana Fortunato
Specialist
3 Homozygous familial hypercholesterolemia publications
TT
Tycho R Tromp
Specialist
3 Homozygous familial hypercholesterolemia publications
MK
Meral Kayikcioglu
Specialist
3 Homozygous familial hypercholesterolemia publications

Treatment Centers

8 centers
⚗️ Trial Site

Hospices Civils de Lyon

📍 Bron

👤 Jerome Honnorat, Pr

👤 Sebastien HASCOËT

⚗️ Trial Site

CHU Nantes

📍 Nantes

👤 Sebastien HASCOËT

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 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

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

Financial Resources

5 resources
Leqvio(inclisiran)Novartis Pharmaceuticals Corporation
Praluent(alirocumab)Regeneron Pharmaceuticals, Inc.
Evkeeza(evinacumab-dgnb)Regeneron Pharmaceuticals, Inc.
Crestor(rosuvastatin)iPR Pharmaceuticals, Inc.
Juxtapid(lomitapide)Chiesi Farmaceutici S.p.A.

Travel Grants

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Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Homozygous familial hypercholesterolemia

5 articles
NewsJOURNAL OF CLINICAL LIPIDOLOGYApr 19, 2026
A case of presumed homozygous familial hypercholesterolemia.
We present a case of a young adult diagnosed with homozygous familial hypercholesterolemia despite a normal lipid panel. A deeper dive into the detail
NewsJOURNAL OF CLINICAL LIPIDOLOGYApr 19, 2026
LDL-C target achievement after adding evinacumab in 2 patients with autosomal recessive hypercholesterolemia.
Autosomal recessive hypercholesterolemia (ARH) is a rare form of genetic hypercholesterolemia consequent to pathogenic variants in the low-density lipoprotein r
NewsNATURE CARDIOVASCULAR RESEARCHApr 17, 2026
50 years of apheresis for homozygous familial hypercholesterolemia.
50 years of apheresis for homozygous familial hypercholesterolemia.
NewsJOURNAL OF CLINICAL MEDICINE RESEARCHApr 9, 2026
Novel Approaches to Lipid Management: Beyond Statins and PCSK9 Inhibitors.
The statins remain the foundation of lipid management because they lower low-density lipoprotein cholesterol (LDL-C) and prevent cardiovascular events, and guid
NewsEUROPEAN JOURNAL OF PREVENTIVE CARDIOLOGYMar 27, 2026
Evinacumab with or without lipoprotein apheresis in homozygous familial hypercholesterolaemia.
Homozygous familial hypercholesterolaemia (HoFH) is characterized by markedly elevated low-density lipoprotein cholesterol (LDL-C). Most individuals with HoFH d
See all news about Homozygous familial hypercholesterolemia

Caregiver Resources

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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.What is my (or my child's) current LDL cholesterol level, and what is our target goal?,How soon should we start LDL apheresis, and how often will it be needed?,Which medications are recommended, and what are their side effects?,Am I (or is my child) eligible for newer treatments like evinacumab or lomitapide?,How often should we have cardiac imaging to check for heart and artery damage?,Should other family members be tested for familial hypercholesterolemia?,Are there any clinical trials or new therapies we should consider?

Common questions about Homozygous familial hypercholesterolemia

What is Homozygous familial hypercholesterolemia?

Homozygous familial hypercholesterolemia (HoFH) is a rare and serious genetic condition that causes extremely high levels of LDL cholesterol — often called "bad cholesterol" — in the blood from birth. It is also sometimes referred to as homozygous FH. In this condition, a person inherits two copies of a faulty gene (one from each parent), which means the body's ability to remove LDL cholesterol from the blood is severely impaired or completely absent. As a result, cholesterol builds up in the walls of arteries at a very young age, leading to a condition called atherosclerosis (hardening and na

How is Homozygous familial hypercholesterolemia inherited?

Homozygous familial hypercholesterolemia follows a autosomal recessive inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Homozygous familial hypercholesterolemia typically begin?

Typical onset of Homozygous familial hypercholesterolemia is childhood. Age of onset can vary across affected individuals.

Are there clinical trials for Homozygous familial hypercholesterolemia?

Yes — 14 recruiting clinical trials are currently listed for Homozygous familial hypercholesterolemia on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Homozygous familial hypercholesterolemia?

25 specialists and care centers treating Homozygous familial hypercholesterolemia are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Homozygous familial hypercholesterolemia?

6 patient support programs are currently tracked on UniteRare for Homozygous familial hypercholesterolemia. See the treatments and support programs sections for copay assistance, eligibility, and contact details.