2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Familial Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT04941599

Run by

Vanderbilt University Medical Center

People needed

72

Starts

2024-02-14

Expected to finish

2027-12-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals with heterozygous Familial Hypercholesterolemia.

You may not qualify if…

• 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 is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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