Actively Recruiting
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
Led by Vanderbilt University Medical Center · Updated on 2026-05-06
72
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. The Investigators plan to first study subjects with Familial Hypercholesterolemia (FH), treating them with 750 mg of 2-HOBA or placebo every 8 hours for 6 weeks.
CONDITIONS
Official Title
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals with heterozygous Familial Hypercholesterolemia.
You will not qualify if you...
- Myocardial infarction or stroke within the last 6 months
- Unstable angina or symptoms of angina within the last 3 months
- NYHA class III or IV heart failure or left ventricular ejection fraction less than 30%
- Poorly controlled hypertension with systolic blood pressure over 180 mm Hg or diastolic blood pressure over 110 mm Hg
- Pregnancy
- Evidence of previous acute coronary syndrome
- Current smokers
- Type 2 Diabetes Mellitus
- Obesity with body mass index over 30
- Hypertriglyceridemia with fasting triglycerides over 250 mg/dl
- Renal insufficiency with creatinine over 1.8
- Liver disease with elevated liver enzymes over twice the upper limit of normal
- Hypothyroidism
- Nephrotic syndrome
- Rheumatoid arthritis
- Systemic lupus erythematosus
- AIDS or HIV infection
- History of cancer in any organ within the last 5 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
A
Anca Ifrim, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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