Clinical Trial

A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping

Study acronym: SAFARI44
Recruiting Phase 3
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Summary
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping
Protocol Amendment History 3 changes
notable Trial sites expanded: 7 -> 10 locations 2026-08-12
critical Recruitment opened 2026-08-05
notable Trial sites expanded: 0 -> 7 locations 2026-08-05
Trial Details
NCT Number NCT07587242
Lead Sponsor Avidity Biosciences, Inc.
Conditions Muscular Dystrophies, Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy), Muscular Disorders, Atrophic, Muscular Disease, Musculoskeletal Diseases, Neuromuscular Diseases (NMD), Nervous System Diseases, Genetic Diseases +6 more
Enrollment 70 participants
Start Date 2026-08
Primary Completion 2029-05 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-11