NCT04941599RecruitingPhase 2
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 18 Jun 2021
- Start date
- Feb 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT04941599
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 72
- From Feb 2024 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- evidence of a previous acute coronary syndrome,
Other illness
- Myocardial infarction or stroke within the last 6 months
- unstable angina, symptoms of angina within the last 3 months
- poorly controlled hypertension: SBP \> 180 mm Hg or DBP \> 110 mm Hg,
- individuals with Type 2 Diabetes Mellitus, obesity (BMI \> 30),
- renal insufficiency (Cr \> 1.8),
- nephrotic syndrome,
- AIDS or HIV
- history of malignancy of any organ in last 5 years.
Lab values
- NYHA class III or IV heart failure or LVEF \< 30%
- hypertriglyceridemia (fasting TG \> 250 mg/dl),
- hepatic disease (aspartate aminotransferase(AST) or alanine aminotransferase (ALT) \> 2x ULN),
Other
- pregnancy,
- current smokers,
- hypothyroidism,
- rheumatoid arthritis,
- systemic lupus erythematosus,
Who the study is looking for
- Individuals with heterozygous Familial Hypercholesterolemia.
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.