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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified October 2025 by Vanderbilt University Medical Center
Sponsor
Vanderbilt University Medical Center
Information Provided by (Responsible Party)
MacRae F. Linton, MD
Clinicaltrials.gov Identifier
NCT04941599
Other Study ID Numbers:
201575
First Submitted
June 17, 2021
First Posted
June 27, 2021
Last Update Posted
February 3, 2026
Last Verified
October 2025

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Familial Hypercholesterolemia
Drug: 2-HydroxybenzylamineOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment72 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposePrevention
Official Title2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
Study Start DateFebruary 13, 2024
Actual Primary Completion Date2mos 5d from now
Actual Study Completion Date8mos 6d from now

Groups and Cohorts

Group/CohortIntervention/Treatment
2-Hydroxybenzylamine (2-HOBA)
2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.
Drug: 2-Hydroxybenzylamine
2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.
Placebo
Placebo- three tabs TID (po) for 6 weeks.
Other: Placebo
Placebo 250 mg three tabs TID (po) for 6 weeks.

Outcome Measures

Primary Outcome Measures
  1. 2-HOBA increases HDL cholesterol efflux capacity.
    Change in HDL cholesterol efflux capacity will be measured by macrophage cholesterol efflux assay.
Secondary Outcome Measures
  1. 2-HOBA reduces modification of HDL by Isolevuglandin (Iso-LG).
    Measurement of the Iso-LG-lysine lactam by mass spectrometry.
  2. 2-HOBA reduces modification of HDL by malondialdehyde (MDA).
    Measurement of dilysyl-MDA cross-links by mass spectrometry.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsVanderbilt University Medical Center
Locations
Vanderbilt University Medical Center | Nashville Tennessee, United States, 37212
Investigators
Principal Investigator: MacRae F. Linton, MD, Vanderbilt University Medical Center