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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 6
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have a genetic condition that causes high cholesterol.
Select...
I have a genetic condition that causes high cholesterol.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
2-HOBA increases HDL cholesterol efflux capacity.
Secondary outcome measures
2-HOBA reduces modification of HDL by Isolevuglandin (Iso-LG).
2-HOBA reduces modification of HDL by malondialdehyde (MDA).
Other outcome measures
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
853 Previous Clinical Trials
670,996 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,365 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a patient is 35 years old or younger, could they qualify for this research?

"This study is seeking participants that fall within the age range of 18 to 69 years old."

Answered by AI

Has 2-Hydroxybenzylamine (2-HOBA) been cleared by the FDA?

"There is some evidence to support 2-Hydroxybenzylamine's (2-HOBA) safety, but none for efficacy. This received a score of 2."

Answered by AI

Are patients being actively sought for this research project?

"Clinicaltrials.gov indicates that this study is no longer looking for participants. The trial was originally posted on January 15th, 2023 but the most recent edit was November 4th, 2022. Although this research is not ongoing, there are 77 other studies that are still recruiting patients."

Answered by AI

Is 2-Hydroxybenzylamine (2-HOBA) a new or novel medication?

"There are 2 ongoing studies involving 2-Hydroxybenzylamine (2-HOBA), and neither of them have progressed to Phase 3 yet. Most of the trials related to this treatment are based in Nashville, but there are also active research sites in 2 other locations."

Answered by AI

How many total participants will be used for this clinical research?

"Unfortunately, this particular study is no longer looking for participants. The last time it was updated was on November 4th, 2022 and it was originally posted on January 15th, 2023. However, there are currently 75 other trials recruiting patients with primary hypercholesterolemia and 2 studies involving 2-Hydroxybenzylamine (2-HOBA) that are still enrolling patients."

Answered by AI

How does one qualify for this particular medical study?

"The current study is investigating a possible treatment for primary hypercholesterolemia and thus requires participants that have this condition. In addition, all potential patients must be between 18-69 years old. Right now, the plan is to enroll 72 individuals in total."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Crestor, Atorvastatin, Simvastatin have all been tried, and my cholesterol has not really changed much with any of them. Crestor has been the most effective.
PatientReceived 2+ prior treatments
My physician has tried several medications to lower my cholesterol, but none seem to work. I am currently taking medications for high cholesterol that are not having an impact on my numbers.
PatientReceived 2+ prior treatments
~48 spots leftby Jul 2025