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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04941599

Enrollment

Registered

2021-06-28

Start date

2024-02-14

Completion date

2027-12-31

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Hypercholesterolemia

Keywords

Familial Hypercholesterolemia, HDL, LDL, 2-HOBA, HDL Function

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Subjects will be randomized to treatment with either 2-Hydroxybenzylamine (2-HOBA) , a naturally occuring dicarbonyl scavenger, or placebo for 6 weeks.

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
2-HOBA increases HDL cholesterol efflux capacity.	Baseline to week 6	Change in HDL cholesterol efflux capacity will be measured by macrophage cholesterol efflux assay.

Secondary

Measure	Time frame	Description
2-HOBA reduces modification of HDL by Isolevuglandin (Iso-LG).	Baseline to week 6	Measurement of the Iso-LG-lysine lactam by mass spectrometry.
2-HOBA reduces modification of HDL by malondialdehyde (MDA).	Baseline to week 6	Measurement of dilysyl-MDA cross-links by mass spectrometry.

Countries

United States

Contacts

CONTACTAnca Ifrim, RN

anca.ifrim@vumc.org6155224210

PRINCIPAL_INVESTIGATORMacRae F. Linton, MD

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026