HyperlipidemiaNCT07198009
2-HOBA Supplementation in People With Elevated Lipoprotein(a)
A study testing 2-HOBA (Hobamine) in people with Hyperlipidemia and Elevated Lp(a), run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hyperlipidemia, Elevated Lp(a)
- What is being tested?
- 2-HOBA (Hobamine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lipid Clinic at Brown University Health
Providence, Rhode Island, 02914
Wenliang Song, MD, 4014449851, wsong@brownhealth.org
Wenliang Song, MD
About this study
Official title: Modulation of Bioactive Lipids in Lipid Disorders: a Pilot Study of 2-HOBA Supplementation in Individuals 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
Read the 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)
- Being tested
- 2-HOBA (Hobamine)
- Keywords
- Oxidized Phospholipids, lp(a), 2HOBA
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 2-HOBA Supplementation for Elevated Lipoprotein(a) | Experimental | Participants will take oral 2-hydroxybenzylamine (2-HOBA, Hobamine) at a dose of 400 mg three times daily with meals for 6 weeks. Receives: Dietary Supplement: 2-HOBA (Hobamine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oxidized phospholipids (OxPL) on circulating lipoprotein(a)
OxPL levels on circulating lipoprotein(a) will be measured in blood samples collected before and after 6 weeks of oral 2-HOBA supplementation.
Measured: 6 weeks
Secondary outcomes (8)
High-sensitivity CRP
High-sensitivity CRP will be measured in blood samples to assess changes in systemic inflammation after 2-HOBA supplementation.
Measured: 6 weeks
Interleukin-6
IL-6 levels will be measured in plasma to evaluate the effect of 2-HOBA on inflammatory signaling.
Measured: 6 weeks
Tumor Necrosis Factor-alpha (TNF-α)
TNF-α concentrations will be measured in plasma as an additional marker of inflammation.
Measured: 6 weeks
Fibrinogen
Plasma fibrinogen levels will be measured to assess changes in blood clotting potential.
Measured: 6 weeks
D-dimer
D-dimer will be measured in plasma as a marker of fibrinolysis and thrombosis.
Measured: 6 weeks
Thromboxane
Urinary and plasma thromboxane B2 will be analyzed to evaluate platelet activation.
Measured: 6 weeks
Platelet aggregation
Platelet aggregation will be measured using agonists such as arachidonic acid, ADP, and collagen.
Measured: 6 weeks
Plasma Lp(a) concentrations
Plasma Lp(a) concentrations will be measured to monitor any effects of 2-HOBA on lipoprotein levels.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenliang Song, MD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198009
- Sponsor's protocol ID
- 2343236
- Other IDs
- 2343236
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Bioactive Lipids in Lipid Disorders: a Pilot Study of 2-HOBA Supplementation in Individuals With Elevated Lipoprotein(a)
- ClinicalTrials.gov ID
- NCT07198009
- Acronym / sponsor ID
- 2343236
- Conditions
- Hyperlipidemia, Elevated Lp(a)
- Keywords
- Oxidized Phospholipids, lp(a), 2HOBA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2-HOBA Supplementation for Elevated Lipoprotein(a) | Experimental | Dietary Supplement: 2-HOBA (Hobamine)Participants will take oral 2-hydroxybenzylamine (2-HOBA, Hobamine) at a dose of 400 mg three times daily with meals for 6 weeks. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | 2-HOBA Supplementation for Elevated Lipoprotein(a) |
Primary outcome
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.
8 secondary outcomes
High-sensitivity CRP
Time frame: 6 weeks
Interleukin-6
Time frame: 6 weeks
Tumor Necrosis Factor-alpha (TNF-α)
Time frame: 6 weeks
Fibrinogen
Time frame: 6 weeks
D-dimer
Time frame: 6 weeks
Thromboxane
Time frame: 6 weeks
Platelet aggregation
Time frame: 6 weeks
Plasma Lp(a) concentrations
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenliang Song, MD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-HOBA (Hobamine) in people with Hyperlipidemia and Elevated Lp(a), run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenliang Song, MD (4014449851, wsong@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oxidized phospholipids (OxPL) on circulating lipoprotein(a) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.