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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~baseline to week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 6 for reporting.

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 more

Trial 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
939,554 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,926 Previous Clinical Trials
47,764,200 Total Patients Enrolled
MacRae F. Linton, MDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

2-Hydroxybenzylamine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04941599 — Phase 2
High Cholesterol Research Study Groups: Placebo, 2-Hydroxybenzylamine (2-HOBA)
High Cholesterol Clinical Trial 2023: 2-Hydroxybenzylamine Highlights & Side Effects. Trial Name: NCT04941599 — Phase 2
2-Hydroxybenzylamine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04941599 — Phase 2
High Cholesterol Patient Testimony for trial: Trial Name: NCT04941599 — Phase 2
~31 spots leftby Jul 2025
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