Clinical Trial

Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)

Study acronym: Fortify
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study will evaluate the safety and efficacy of long-term administration of BBP-418 in patients with LGMD2I/R9. The study will include patients ages 12 to 60, consistent with the existing preclinical toxicology profile. This will encompass the significant majority of existing diagnosed patients based upon the established epidemiology of the disease.
Protocol Amendment History 30 amendments
This ClinicalTrials.gov record has been amended 30 times since 2023-03-16; most recent amendment 2025-09-26.
Status change: Recruiting → Active, Not Recruiting 2024-09-25
Status change: Not Yet Recruiting → Recruiting 2023-06-01
Trial Details
NCT Number NCT05775848
Lead Sponsor ML Bio Solutions, Inc.
Conditions Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)
Enrollment 81 participants
Start Date 2023-05-31
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-09-29