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A Gene Transfer Single Dose Study to Evaluate the Safety, Tolerability and Efficacy of SRP-9003 in Non-Ambulatory and Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2E/R4 (Beta-Sarcoglycan [β-SG] Deficiency)

StatusActive, Not Recruiting
PhasePhase 1
Started2022-12-19
View on ClinicalTrials.gov ↗

Amendment history

2026-02-17
2 amendments v3-v4
2 re-verifications since 2024-12-20, no change to tracked fields
2023-09-18
Enrolling by Invitation→Active, Not Recruiting Study Status, Study Design v2
Trial statusEnrolling by Invitation→Active, Not Recruiting
Primary completion date2026-01-31→2028-08-28
Completion date2027-01-31→2028-08-28
Enrollment targetestimated 5→confirmed 6
2023-08-15
Study Status, Contacts/Locations v1
Study sites1→2
2023-05-17
Original filing
The primary purpose of this study is to evaluate the safety of SRP-9003 and to quantify expression of β-SG in the skeletal muscle of participants with limb-girdle muscular dystrophy, type 2E/R4 (LGMD2E/R4). The study will include both ambulatory (Cohort 1) and non-ambulatory (Cohort 2) participants.
Trial Details
NCT Number NCT05876780
Lead Sponsor Sarepta Therapeutics, Inc.
Conditions Limb Girdle Muscular Dystrophy
Enrollment 6 participants
Start Date 2022-12-19
Primary Completion 2028-08-28 (estimated)
Study Completion 2028-08-28 (estimated)
Updated on ClinicalTrials.gov 2026-02-19