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NCT07589764 · ClinicalTrials.gov registry record · Phase 1
A Widely Inclusive, Hybrid-Decentralized Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS
A Phase 1 study, sponsored by Duke University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT07589764: Clinical Trial Phase 1 study, sponsored by Duke University.
NCT07589764 is a Phase 1 study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07589764, a Phase 1 study, has not yet begun recruiting, sponsored by Duke University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is an open label trial of a supplement called HMB in patients with ALS. The researchers are evaluating its safety and tolerability, as well as its ability to lower insulin-like growth-factor binding protein 7 (IGFBP7) and Neurofilament light chain levels (NFL) and to slow ALS Functional Rating Scale, Revised (ALSFRS-R) progression.
Primary Outcome
A quickly administered (five minute) ordinal rating scale (ratings 0-4) used to determine patients' assessments of their capability and independence in 12 functional activities. All 12 activities are relevant to people living with ALS.The ALSFRS-R declines linearly with time over a wide range during the course of ALS and it has been validated for telephone use. The ALSFRS-R Range is 0-48. The more points, the better the person is functioning.
Interventions
- DRUG β-hydroxy-β-methylbutyrate (HMB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2026-08-01 |
| Phase | Phase 1 |
What is known before NCT07589764 opens enrollment
NCT07589764 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 1 intervention - of which β-hydroxy-β-methylbutyrate (HMB) is the first listed.
NCT07589764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07589764 about?
NCT07589764 is a clinical study titled "A Widely Inclusive, Hybrid-Decentralized Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS". This is an open label trial of a supplement called HMB in patients with ALS. The researchers are evaluating its safety and tolerability, as well as its ability to lower insulin-like growth-factor binding protein 7 (IGFBP7) and Neurofilament light chain levels (NFL) and to slow ALS Functional Rating ...
What is the current status of trial NCT07589764?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2026-07-01. Estimated completion is 2026-08-01.
What interventions are being tested in trial NCT07589764?
The interventions under investigation include: β-hydroxy-β-methylbutyrate (HMB) (DRUG).
Who is sponsoring clinical trial NCT07589764?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07589764's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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