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2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)

StatusRecruiting
PhasePhase 2
Started2024-02-14
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 30, 2026 → Jun 30, 2027
See other at-risk trials from Vanderbilt University Medical Center

Amendment history

2026-08-05
Study Status v14
Primary completion pushed: 2026-06-30 → 2027-06-30
Completion pushed: 2026-12-31 → 2027-12-31
2026-05-01
Study Status v13
Re-verified, no change to tracked fields
2026-02-02
Study Status v12
Primary completion date2025-12→2026-06-30
Completion date2026-06→2026-12-31
2025-11-04
Study Status v11
Completion date2025-12→2026-06
2025-08-15
Study Status v10
Primary completion date2025-07→2025-12
Completion date2025-11→2025-12
Show 9 earlier versions
2024-12-11
Study Status, Study Design, Outcome Measures v9
Re-verified, no change to tracked fields
2024-02-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2024-02-14
Study sitesdetails revised at 1 of 1 site
2023-10-31
Study Status v7
Start date2023-09→2023-11
2023-09-11
Study Status v6
Primary completion date2024-09-30→2025-07
Completion date2024-09-30→2025-11
Start date2023-08-22→2023-09
2023-08-09
Study Status v5
Start date2023-04-15→2023-08-22
2023-02-16
Study Status v4
Start date2023-01-15→2023-04-15
2022-11-04
Study Status v3
Start date2022-08-15→2023-01-15
2022-06-24
Study Status v2
Primary completion date2023-09-30→2024-09-30
Completion date2023-09-30→2024-09-30
Start date2021-08-15→2022-08-15
2021-07-06
Study Status, Sponsor/Collaborators, Outcome Measures v1
Re-verified, no change to tracked fields
2021-06-18
Original filing
The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH. The Investigators plan to first study subjects with Familial Hypercholesterolemia (FH), treating them with 750 mg of 2-HOBA or placebo every 8 hours for 6 weeks.
Trial Details
NCT Number NCT04941599
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Familial Hypercholesterolemia
Enrollment 72 participants
Start Date 2024-02-14
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-07