A Widely Inclusive, Hybrid-Decentralized Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07589764
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Amyotrophic Lateral Sclerosis ALS

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • β-hydroxy-β-methylbutyrate (HMB) — DRUG
    Our source of HMB will be Life Extension's "Wellness Code Muscle Strength \& Restore Formula. The dose will be 3g daily, which has previously been shown to be safe and well-tolerated, and to reduce IGFBP7 blood levels in humans.

Study Details

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 Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: β-hydroxy-β-methylbutyrate (HMB) administration

Primary Outcome Measure

ALS Functional Rating Scale, Revised (ALSFRS-R) [ Time Frame: Baseline, month 3, month 9 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27705
Richard Bedlack, MD. PhD
[email protected]
Richard Bedlack, MD, PhD (PRINCIPAL_INVESTIGATOR)
Temple UniversityPhiladelphiaPennsylvania19122
Christopher Pizzica
[email protected]
Terry Heiman-Patterson, MD (PRINCIPAL_INVESTIGATOR)

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