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

Last updated: December 11, 2024
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Familial Hypercholesterolemia

Hypercholesterolemia

Dyslipidemia

Treatment

2-Hydroxybenzylamine

Placebo

Clinical Study ID

NCT04941599
201575
2P01HL116263-06
  • Ages 18-69
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Individuals with heterozygous Familial Hypercholesterolemia.

Exclusion

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.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: 2-Hydroxybenzylamine
Phase: 2
Study Start date:
February 14, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

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