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NCT04941599 · ClinicalTrials.gov registry record · Phase 2
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
A Phase 2 study of Familial Hypercholesterolemia, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT04941599: Recruiting Phase 2 study of Familial Hypercholesterolemia, sponsored by Vanderbilt University Medical Center.
NCT04941599 is a Phase 2 study of Familial Hypercholesterolemia that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 72 participants, below the 216-participant average among 7 other Familial Hypercholesterolemia trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04941599, a Phase 2 study of Familial Hypercholesterolemia, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Change in HDL cholesterol efflux capacity will be measured by macrophage cholesterol efflux assay.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG 2-Hydroxybenzylamine
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-02-14 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04941599 shows while recruiting
NCT04941599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 216-participant average among 7 other Familial Hypercholesterolemia trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Familial Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04941599 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04941599 about?
NCT04941599 is a clinical study titled "2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)". 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...
What is the current status of trial NCT04941599?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2024-02-14. Estimated completion is 2026-12-31.
What conditions does trial NCT04941599 study?
This clinical trial studies the following conditions: Familial Hypercholesterolemia.
What interventions are being tested in trial NCT04941599?
The interventions under investigation include: Placebo (OTHER), 2-Hydroxybenzylamine (DRUG).
Who is sponsoring clinical trial NCT04941599?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04941599 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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