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AOC 1044

Phase 3

Muscular Dystrophies | Small molecule | Rare Disease |Avidity Biosciences, Inc.|Last Updated: Jul 13, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical trial landscape

AOC 1044 · 1 trial · 14 indications

Phase 3 1
NCT07587242A 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 SkippingMuscular Dystrophies
NOT YET_RECRUITING70 Analytics
PHASE3NOT YET_RECRUITING
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
Muscular Dystrophies
NCT0758724270
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Study Endpoints
Primary Endpoints
Change from Baseline in Time to Rise (TTR) Velocity at Week 54
Baseline, Week 54
Secondary Endpoints
Change from Baseline in Creatine Kinase (CK) at Week 54
Baseline, Week 54
Change from Baseline in 4-Stair Climb (4SC) Velocity at Week 54
Baseline, Week 54
Change from Baseline in 10-Meter Walk/Run Test (10MWRT) Velocity at Week 54
Baseline, Week 54
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AOC 1044EXPERIMENTALParticipants will receive AOC 1044 intravenously (IV) every 6 weeks (Q6W) during the 54-week double-blind treatment period, followed by a 54-week open-label treatment period in which the same participants will continue to receive AOC 1044 IV Q6W
PlaceboPLACEBO_COMPARATORParticipants will receive placebo (saline) IV Q6W during the 54-week double-blind treatment period, followed by a 54-week open-label treatment period in which all participants will then receive AOC 1044 IV Q6W
Interventions
NameTypeDescription
AOC 1044DRUGAOC 1044 will be administered by intravenous (IV) infusion
PlaceboDRUGPlacebo will be administered by intravenous (IV) infusion
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Eligibility Criteria
Age Range7 Years to 16 Years
SexMALE
Healthy VolunteersNo

Key Inclusion Criteria: * Ambulatory males with clinical and genetic diagnosis of DMD * Acceptable genetic test confirming dystrophin gene mutation amenable to exon 44 skipping * 7 to 16 years of age at time of consent * TTR and NSAA assessment completed within the protocol specified parameters at ...

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Recent Changes (Last 90 Days)
LOWJul 13, 2026NCT07587242lastUpdatePostDate: changed
LOWJul 13, 2026NCT07587242lastUpdatePostDate: changed
LOWMay 26, 2026NCT07587242primaryCompletionDate: changed
LOWMay 24, 2026NCT07587242studyFirstPostDate: changed
LOWMay 21, 2026NCT07587242NEW_TRIAL: changed
LOWMay 21, 2026NCT07587242NEW_TRIAL: changed