Testing the supplement HMB in people with amyotrophic lateral sclerosis
Tests the supplement HMB for safety and effect in adults with ALS.
Plain-language title generated from the registry record
Registry title: Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS
Key facts
- Where
- Durham and Philadelphia, United StatesSee the 2 sites
- Phase
- Phase 1
Where in United States
- Duke University Medical CenterDurham, United StatesNo longer taking part
- Temple UniversityPhiladelphia, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Duke University
- Trial code
- NCT07589764
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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 Scale, Revised (ALSFRS-R) progression.
Inclusion: Male or female aged at least 18 years; Sporadic or familial ALS diagnosed as per Gold Coast Criteria (37); Patient is able to understand and express informed consent (in the opinion of the site investigator); Patient is able to read and write English; Patient is expected to survive for the duration of the trial; Women must not be pregnant (will have evidence of a negative pregnancy test obtained by study team at baseline, or by local physician within past 7 days or be post-menopausal); Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception, or other hormonal contraception, for example patch or contraceptive ring), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.
Exclusion: Prior side effects from HMB deemed to be significant by the investigator; Patient has a medical or psychiatric illness that could in the investigator's opinion interfere with the patient's ability to participate in this study; Elevated serum calcium or vitamin D levels; Actively or recently (within past 30 days) participating in another intervention trial; Currently or recently (within 30 days) taking HMB; Pregnant women or women currently breastfeeding; Life expectancy shorter than the duration of the trial.