Using 2-HOBA to improve HDL function in patients with Familial Hypercholesterolemia
Official title: 2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
Run by Vanderbilt University Medical Center · NCT04941599 · Data updated 2026-11-12
This study is testing if a new treatment called 2-HOBA can help improve cholesterol function in people with Familial Hypercholesterolemia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | February 14, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT04941599 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with heterozygous Familial Hypercholesterolemia.
✕Probably not a fit
Patients with recent cardiovascular events, poorly controlled hypertension, or other significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of 2-Hydroxybenzylamine (2-HOBA) on individuals with heterozygous Familial Hypercholesterolemia (FH). Participants will receive either 750 mg of 2-HOBA or a placebo every 8 hours for a duration of 6 weeks. The primary aim is to determine if 2-HOBA can reduce the modification of HDL and LDL cholesterol and enhance HDL function. The study is designed to provide insights into potential new treatments for managing cholesterol levels in FH patients.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cholesterol management and cardiovascular health for patients with Familial Hypercholesterolemia.
How similar studies have gone: While there have been studies on HDL function, the specific use of 2-HOBA in this context is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals with heterozygous Familial Hypercholesterolemia. Exclusion Criteria: * Myocardial infarction or stroke within the last 6 months * unstable angina, symptoms of angina within the last 3 months * NYHA class III or IV heart failure or LVEF \< 30% * poorly controlled hypertension: SBP \> 180 mm Hg or DBP \> 110 mm Hg, * pregnancy, * evidence of a previous acute coronary syndrome, * current smokers, * individuals with Type 2 Diabetes Mellitus, obesity (BMI \> 30), * hypertriglyceridemia (fasting TG \> 250 mg/dl), * renal insufficiency (Cr \> 1.8), * hepatic disease (aspartate aminotransferase(AST) or alanine aminotransferase (ALT) \> 2x ULN), * hypothyroidism, * nephrotic syndrome, * rheumatoid arthritis, * systemic lupus erythematosus, * AIDS or HIV * history of malignancy of any organ in last 5 years.
Where it's running
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Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Principal investigator: MacRae F. Linton, MD — Vanderbilt University Medical Center
- Study coordinator: Anca Ifrim, RN
- Email: anca.ifrim@vumc.org
- Phone: 6155224210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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ORIGIN-FH: Newborn screening to detect familial high cholesterol
This project will test a genetic cheek swab of parents plus blood screening of newborns to find familial high cholesterol in babies born to parents with familial hypercholesterolemia.
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Registry for hereditary cardiovascular diseases in Brazil
This study is trying to create a registry of Brazilian patients with hereditary heart diseases to see how common certain genetic changes are in people with these conditions.
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Exploring YOLT-101 for treating Familial Hypercholesterolemia
This study is testing a new treatment called YOLT-101 to see if it can safely lower cholesterol levels in people with familial hypercholesterolemia.
-
Atlantic program to optimize cholesterol-lowering care
This program will try coordinated outreach with primary care providers to lower LDL-C in people with familial hypercholesterolemia or LDL-C ≥160 mg/dL.
-
Observational study on genetic lipid disorders in Italy
This study looks at families with high cholesterol to see how genetics affect their condition and treatment, using information gathered during regular doctor visits.
-
Improving detection of familial hypercholesterolemia through lab comments on cholesterol levels
This study is testing if adding helpful comments about high cholesterol levels in lab reports can lead to more people being referred for familial hypercholesterolemia diagnosis and treatment in Southern Denmark.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.