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New treatment option for Familial Hypercholesterolemia
Official title 2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
ClinicalTrials.gov ID: NCT04941599
What this study is testing
What is 2-Hydroxybenzylamine?
2-Hydroxybenzylamine is an investigational medicine, being studied as a potential treatment for familial hypercholesterolemia.
Also referred to as 2-HOBA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- Individuals with heterozygous Familial Hypercholesterolemia.
You likely can't join if
- 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,
See the full eligibility criteria
- Individuals with heterozygous Familial Hypercholesterolemia.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.