RecruitingPhase 2NCT04941599

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


Sponsor

Vanderbilt University Medical Center

Enrollment

72 participants

Start Date

Feb 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a compound called 2-HOBA (2-hydroxybenzylamine) can improve the function of HDL cholesterol (the 'good' cholesterol) in people with familial hypercholesterolemia (FH) — a genetic condition that causes very high LDL ('bad') cholesterol from birth. In FH, HDL often becomes damaged and dysfunctional; 2-HOBA may prevent this damage and help HDL protect the heart. You may be eligible if... - You are between 18 and 69 years old - You have been diagnosed with heterozygous familial hypercholesterolemia You may NOT be eligible if... - You have had a heart attack or stroke in the last 6 months - You have unstable or recent angina (chest pain) - You have severe heart failure (NYHA class III or IV) or very poor heart function - You have poorly controlled high blood pressure - You are a current smoker - You have Type 2 diabetes, obesity (BMI above 30), high triglycerides, or kidney problems - You have liver disease, thyroid problems, rheumatoid arthritis, lupus, HIV, or nephrotic syndrome - You have a history of any cancer in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG2-Hydroxybenzylamine

2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.

OTHERPlacebo

Placebo 250 mg three tabs TID (po) for 6 weeks.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT04941599


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