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

NCT ID: NCT04941599

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Familial Hypercholesterolemia

Keywords

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Familial Hypercholesterolemia HDL LDL 2-HOBA HDL Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2-Hydroxybenzylamine (2-HOBA)

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

Group Type ACTIVE_COMPARATOR

2-Hydroxybenzylamine

Intervention Type DRUG

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

Placebo

Placebo- three tabs TID (po) for 6 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo 250 mg three tabs TID (po) for 6 weeks.

Interventions

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2-Hydroxybenzylamine

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

Intervention Type DRUG

Placebo

Placebo 250 mg three tabs TID (po) for 6 weeks.

Intervention Type OTHER

Other Intervention Names

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2-HOBA

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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MacRae F. Linton, MD

Professor of Medicine and Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MacRae F. Linton, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anca Ifrim, RN

Role: CONTACT

Phone: 6155224210

Email: [email protected]

Other Identifiers

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2P01HL116263-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201575

Identifier Type: -

Identifier Source: org_study_id