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

NCT ID: NCT07198009

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-11-30

Brief Summary

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

Detailed Description

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.

Conditions

Hyperlipidemia; Elevated Lp(a)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

2-HOBA Supplementation for Elevated Lipoprotein(a)

Participants will take oral 2-hydroxybenzylamine (2-HOBA, Hobamine) at a dose of 400 mg three times daily with meals for 6 weeks.

Group Type: EXPERIMENTAL

2-HOBA (Hobamine)

Intervention Type: 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.

Interventions

2-HOBA (Hobamine)

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenliang Song, MD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

Lipid Clinic at Brown University Health

Providence, Rhode Island, United States

Countries

United States

Central Contacts

Wenliang Song, MD

Role: CONTACT

wsong@brownhealth.org

4014449851

Daria Salamevich

Role: CONTACT

dsalamevich@brownhealth.org

4014449857

Facility Contacts

Wenliang Song, MD

Role: primary

wsong@brownhealth.org

4014449851

Other Identifiers

2343236

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2343236

Identifier Type: -

Identifier Source: org_study_id