AOC 1044

DRUG4 trials

Sponsors

Avidity Biosciences Inc., Avidity Biosciences, Inc.

Conditions

CongenitalDMDDuchene Muscular DystrophyDuchenneDuchenne Muscular DystrophyDuchenne muscular dystrophyExon 44Genetic Diseases

Phase 1

Study of AOC 1044 in Healthy Adult Volunteers and Participants With Duchenne Muscular Dystrophy (DMD) Mutations Amenable to Exon 44 Skipping

CompletedNCT05670730

Avidity Biosciences, Inc.Duchenne Muscular Dystrophy, Exon 44

Start: 2022-11-09End: 2024-11-25Updated: 2025-07-14

Phase 2

Ph2 Open-label Study of AOC 1044 in Duchenne Muscular Dystrophy Participants With Mutations Amenable to Exon44 Skipping

Active, not recruitingNCT06244082

Avidity Biosciences, Inc.DMD, Duchenne, Duchenne Muscular Dystrophy +1

Start: 2024-01-22End: 2027-04-30Updated: 2026-07-30

Phase 3

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

RecruitingNCT07587242

Avidity Biosciences, Inc.Congenital, DMD, Duchene Muscular Dystrophy +11

Start: 2026-09-01End: 2030-07-01Target: 70Updated: 2026-09-15

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (delpacibart zotadirsen) for the Treatment of DMD with Gene Mutations Amenable to Exon 44 Skipping

Not yet recruitingCTIS2025-523087-20-00

Avidity Biosciences Inc.Duchenne muscular dystrophy

Target: 26Updated: 2026-05-20