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

Inclusion Criteria1

  • Individuals with heterozygous Familial Hypercholesterolemia.

Exclusion Criteria17

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04941599


Related Trials