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2-HOBA for High Cholesterol
Phase 2
Recruiting
Led By MacRae F. Linton, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals with heterozygous Familial Hypercholesterolemia.
Individuals with heterozygous Familial Hypercholesterolemia
Must not have
Systemic lupus erythematosus
Individuals with Type 2 Diabetes Mellitus, obesity (BMI > 30)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 6
Summary
This trial will test whether 2-HOBA can reduce modification of HDL and LDL, and improve HDL function, in people with a genetic condition that causes high cholesterol.
Who is the study for?
This trial is for individuals with a genetic condition called heterozygous Familial Hypercholesterolemia (FH), which causes high cholesterol. It's not suitable for pregnant people, those with recent cancer, severe kidney or liver disease, uncontrolled hypertension, heart failure, recent heart attack or stroke, certain autoimmune diseases like lupus and rheumatoid arthritis, HIV/AIDS, hypothyroidism or if they are current smokers.
What is being tested?
The study is testing whether taking a compound called 2-Hydroxybenzylamine (2-HOBA) can improve the function of HDL ('good' cholesterol) in people with FH. Participants will receive either 750 mg of 2-HOBA or a placebo every eight hours for six weeks to see if there's any difference between the two groups.
What are the potential side effects?
Potential side effects aren't specified here but generally could include digestive discomforts such as nausea or diarrhea when introducing new compounds like 2-HOBA into the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a genetic condition that causes high cholesterol.
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I have a genetic condition that causes high cholesterol.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with systemic lupus erythematosus.
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I have Type 2 Diabetes and my BMI is over 30.
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I have had a heart attack or severe chest pain before.
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I have nephrotic syndrome.
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My liver enzymes are not more than twice the upper limit.
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I have AIDS or HIV.
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My kidney function is reduced with a creatinine level over 1.8.
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My heart's pumping ability is severely reduced.
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I have not had chest pain or angina in the last 3 months.
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I have rheumatoid arthritis.
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I have had cancer in any part of my body in the last 5 years.
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My blood pressure is not higher than 180/110 mm Hg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
2-HOBA increases HDL cholesterol efflux capacity.
Secondary study objectives
2-HOBA reduces modification of HDL by Isolevuglandin (Iso-LG).
2-HOBA reduces modification of HDL by malondialdehyde (MDA).
Other study objectives
Change in HDL anti-inflammatory function in an in vitro assay of macrophage cytokine production (IL-1B, TNFa, IL-6).
Change in HDL anti-oxidant function in an in vitro assay of macrophage reactive oxygen species production.
Change in HDL microRNA and small noncoding ribonucleic acid (sRNA) composition
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: 2-Hydroxybenzylamine (2-HOBA)Active Control1 Intervention
2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo- three tabs TID (po) for 6 weeks.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
901 Previous Clinical Trials
938,610 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,929 Previous Clinical Trials
47,765,155 Total Patients Enrolled
MacRae F. Linton, MDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood has high levels of triglycerides when you haven't eaten for a while.I have been diagnosed with systemic lupus erythematosus.I have Type 2 Diabetes and my BMI is over 30.I have had a heart attack or severe chest pain before.I have an underactive thyroid.I have nephrotic syndrome.I have a genetic condition that causes high cholesterol.My liver enzymes are not more than twice the upper limit.I have AIDS or HIV.My kidney function is reduced with a creatinine level over 1.8.My heart's pumping ability is severely reduced.I have not had a heart attack or stroke in the last 6 months.I have not had chest pain or angina in the last 3 months.You currently smoke cigarettes.I have rheumatoid arthritis.I have had cancer in any part of my body in the last 5 years.My blood pressure is not higher than 180/110 mm Hg.I have a genetic condition that causes high cholesterol.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: 2-Hydroxybenzylamine (2-HOBA)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
High Cholesterol Patient Testimony for trial: Trial Name: NCT04941599 — Phase 2
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