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Recruiting NCT04941599

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

Phase II Interventional Familial Hypercholesterolemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 2-Hydroxybenzylamine, Placebo.
Who it may be relevant to
Registry conditions: Familial Hypercholesterolemia. Basic parameters: 18 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 2-HOBA increases HDL cholesterol efflux capacity. [Time frame: Baseline to week 6]
Secondary outcome measures (2)
  • 2-HOBA reduces modification of HDL by Isolevuglandin (Iso-LG). [Time frame: Baseline to week 6]
  • 2-HOBA reduces modification of HDL by malondialdehyde (MDA). [Time frame: Baseline to week 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT04941599 · 201575 · 2P01HL116263-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗