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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT04941599
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • 2-Hydroxybenzylamine — DRUG
    2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.
  • Placebo — OTHER
    Placebo 250 mg three tabs TID (po) for 6 weeks.

Study Details

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.

Key Dates

Start date
Feb 14, 2024
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: 2-Hydroxybenzylamine (2-HOBA)
    2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.
  • Placebo Comparator: Placebo
    Placebo- three tabs TID (po) for 6 weeks.

Primary Outcome Measure

2-HOBA increases HDL cholesterol efflux capacity. [ Time Frame: Baseline to week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212-

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By research site
Vanderbilt University Medical Center· Nashville, TN

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