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Can a Plant-Based compound boost good cholesterol in High-Risk patients?

NCT ID NCT04941599

Disease control Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether a drug called 2-HOBA can improve the function of HDL (good cholesterol) in people with familial hypercholesterolemia, an inherited condition causing very high cholesterol. Researchers will give 72 participants either 2-HOBA or a placebo for six weeks. The goal is to see if 2-HOBA helps HDL remove cholesterol from cells more effectively, potentially lowering heart disease risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
2-Hydroxybenzylamine (2-HOBA)
What this could lead to
If it works, this could point toward a way to improve cholesterol management and reduce heart disease risk in people with familial hypercholesterolemia.
What could go wrong
This is an early Phase 2 trial with only 72 participants, so results may not apply broadly. The drug may not improve HDL function as hoped, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Individuals with heterozygous Familial Hypercholesterolemia. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia Hyperlipoproteinemia Type II

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Familial hypercholesterolemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37212, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.