A Widely Inclusive, Hybrid-Decentralized Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS
Starting soon · Phase 1
Conditions studied: Amyotrophic Lateral Sclerosis ALS
In brief
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.
Key facts
- Study ID
- NCT07589764
- Run by
- Duke University
- People needed
- 100
- Starts
- 2026-07-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Actively or recently (within past 30 days) participating in another intervention trial.
- Currently or recently (within 30 days) taking HMB
- 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.
- Pregnant women or women currently breastfeeding.
- Elevated serum calcium or vitamin D levels.
- Life expectancy shorter than the duration of the trial.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
- Temple University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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