Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07198009

2-HOBA Supplementation in People With Elevated Lipoprotein(a)

The goal of this clinical trial is to learn if a natural supplement called 2-hydroxybenzylamine (2-HOBA) can reduce harmful oxidized lipids and improve the function of lipoprotein(a) in adults with high lipoprotein(a) levels.

The main questions it aims to answer are:

Does 2-HOBA lower oxidized phospholipids on lipoprotein(a)? Does 2-HOBA reduce markers of inflammation and blood clotting in the blood?

Participants will:

Take 2-HOBA capsules (400 mg, three times daily with meals) for 6 weeks Provide blood and urine samples at the beginning, middle, and end of the study Have lab tests to measure changes in lipids, inflammation, and clotting markers

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lipid Clinic at Brown University Health

Providence, Rhode Island, 02914, United States

Location contact

Wenliang Song, MD

CONTACT

[email protected]

4014449851

Wenliang Song, MD

PRINCIPAL_INVESTIGATOR

About this study

Lipoprotein(a), or Lp(a), is a genetically determined cholesterol particle that increases the risk of heart disease and stroke. High levels of Lp(a) affect about 1 in 4 people, and there are no approved treatments that directly reduce its harmful effects. One reason Lp(a) is thought to be harmful is that it carries oxidized phospholipids, which promote inflammation and blood clotting.

2-hydroxybenzylamine (2-HOBA, also known as Hobamine) is a naturally occurring compound that neutralizes reactive molecules responsible for forming oxidized lipids. Preclinical studies and early human trials suggest that 2-HOBA is safe and may lower the buildup of oxidized phospholipids.

This pilot clinical trial will test whether oral 2-HOBA supplementation can improve the biology of Lp(a) in people with high levels (≥90 mg/dL). Ten adults will take 2-HOBA (400 mg by mouth, three times daily with meals) for 6 weeks. Blood and urine will be collected at three clinic visits (baseline, mid-study, and end of study). Researchers will measure oxidized phospholipids, lipoprotein function, markers of inflammation (such as C-reactive protein and interleukins), and markers of clotting (such as fibrinogen, D-dimer, and platelet activity).

The results will provide early information about whether 2-HOBA can reduce harmful changes linked to high Lp(a) and help guide the design of larger future trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females aged 18-69 years.
  • Elevated Lp(a) levels ≥ 90 mg/dL.
  • Able to provide informed consent and adhere to study schedules.
  • Willing to follow a physician-recommended diet during the study.

Exclusion criteria

  • Pregnant, planning pregnancy during the study period, or currently breastfeeding.
  • Individuals with established cardiovascular disease
  • Planning major changes in diet or exercise routines.
  • Experienced >20% weight change in the past 3 months.
  • Diagnosed with malabsorption syndrome or chronic diarrhea.
  • Abnormal liver, kidney, or thyroid function.
  • Drug or alcohol abuse within the past 6 months, or significant mental/psychological impairment.
  • Have known bleeding disorders (e.g., hemophilia).
  • Planned surgery during the study period.
  • Donated blood within the last 2 weeks or planning to donate during the study.
  • Require regular blood transfusions.

Treatment and study plan

2-HOBA (Hobamine)

Dietary Supplement

Participants will take oral 2-hydroxybenzylamine (2-HOBA, Hobamine), a dietary supplement with Generally Recognized as Safe (GRAS) status. The study dose is 400 mg three times daily with meals for 6 weeks.

Primary outcomes

  1. Change in oxidized phospholipids (OxPL) on circulating lipoprotein(a)

    Time frame: 6 weeks

    OxPL levels on circulating lipoprotein(a) will be measured in blood samples collected before and after 6 weeks of oral 2-HOBA supplementation.

Secondary outcomes

  1. High-sensitivity CRP

    Time frame: 6 weeks

    High-sensitivity CRP will be measured in blood samples to assess changes in systemic inflammation after 2-HOBA supplementation.

  2. Interleukin-6

    Time frame: 6 weeks

    IL-6 levels will be measured in plasma to evaluate the effect of 2-HOBA on inflammatory signaling.

  3. Tumor Necrosis Factor-alpha (TNF-α)

    Time frame: 6 weeks

    TNF-α concentrations will be measured in plasma as an additional marker of inflammation.

  4. Fibrinogen

    Time frame: 6 weeks

    Plasma fibrinogen levels will be measured to assess changes in blood clotting potential.

  5. D-dimer

    Time frame: 6 weeks

    D-dimer will be measured in plasma as a marker of fibrinolysis and thrombosis.

  6. Thromboxane

    Time frame: 6 weeks

    Urinary and plasma thromboxane B2 will be analyzed to evaluate platelet activation.

  7. Platelet aggregation

    Time frame: 6 weeks

    Platelet aggregation will be measured using agonists such as arachidonic acid, ADP, and collagen.

  8. Plasma Lp(a) concentrations

    Time frame: 6 weeks

    Plasma Lp(a) concentrations will be measured to monitor any effects of 2-HOBA on lipoprotein levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Daria Salamevich

CONTACT

[email protected]

4014449857

Wenliang Song, MD

CONTACT

[email protected]

4014449851

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

Modulation of Bioactive Lipids in Lipid Disorders: a Pilot Study of 2-HOBA Supplementation in Individuals With Elevated Lipoprotein(a)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.