Familial Hypercholesterolemia study: 2-Hydroxybenzylamine
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?
This is an investigational pill being studied to see if it can help people with 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
- This study aims to find out if 2-HOBA can stop certain cholesterol particles from changing in harmful ways and help them work better.
- Who it's for
- The study is looking for adults with heterozygous familial hypercholesterolemia, a genetic condition that causes high cholesterol.
- What's involved
- Participants will take 750 mg of 2-HOBA or a placebo pill every 8 hours for 6 weeks.
- Time commitment
- The study lasts 6 weeks and requires taking medication three times a day.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.