Study of 2-Hydroxybenzylamine 2-HOBA to Improve HDL Function in Adults With Familial Hypercholesterolemia

What this Trial Is About

Researchers are evaluating the effects of 2-Hydroxybenzylamine 2-HOBA on people with heterozygous Familial Hypercholesterolemia FH. The study aims to test whether 2-HOBA can reduce harmful modification of HDL and LDL cholesterol and improve HDL function. This phase 2 trial is focused on prevention and involves a randomized, placebo-controlled design with quadruple masking to ensure objective results. Participants receive either 750 mg of 2-HOBA given as three 250 mg capsules three times daily or a placebo for six weeks. The study compares these two groups in parallel to assess the impact of 2-HOBA on cholesterol modification and function. The treatment period lasts six weeks, during which participants take the assigned capsules orally. Throughout the study, participants undergo assessments to measure HDL cholesterol efflux capacity and the extent of HDL modification by specific agents like Isolevuglandin and malondialdehyde. These measurements are taken from baseline through week 6. Researchers monitor participants health and safety, with the total involvement lasting at least the six-week treatment period. The trial is sponsored by Vanderbilt University Medical Center and continues through the end of 2027.

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