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NOT YET RECRUITING
NCT07589764
PHASE1

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

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-07-01

Completion Date

2026-08-01

Last Updated

2026-05-15

Healthy Volunteers

No

Interventions

DRUG

β-hydroxy-β-methylbutyrate (HMB)

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.

Locations (2)

Duke University Medical Center

Durham, North Carolina, United States

Temple University

Philadelphia, Pennsylvania, United States