RecruitingPhase 2

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

United States72 participantsStarted 2024-02-14

Plain-language 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.

Who can participate

Age range18 Years – 69 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

2-HOBA increases HDL cholesterol efflux capacity.

Timeframe: Baseline to week 6

Trial details

NCT IDNCT04941599

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Anca Ifrim, RN

6155224210 anca.ifrim@vumc.org

View on ClinicalTrials.gov More Familial Hypercholesterolemia trials