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Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS

Study acronym: ROAR HMB
StatusNot Yet Recruiting
PhasePhase 1
Started2026-10-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 15 months later Jul 1, 2026 → Oct 1, 2027
See other at-risk trials from Duke University

Amendment history

2026-09-02
Study Identification, Study Status v1
Primary completion pushed: 2026-07-01 → 2027-10-01
Completion pushed: 2026-08-01 → 2027-10-01
Start date2026-07-01→2026-10-01
Study title-41 characters
A Widely Inclusive, Hybrid-Decentralized Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS
2026-05-11
Original filing
Duke University
455 trials monitored
See 53 trials at risk
ALS
384 trials monitored
See 17 trials at risk
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.
Trial Details
NCT Number NCT07589764
Lead Sponsor Duke University
Collaborators: Temple University
Conditions Amyotrophic Lateral Sclerosis ALS
Enrollment 100 participants
Start Date 2026-10-01
Primary Completion 2027-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-08