Clinical Trial

Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-251 in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

Study acronym: DELIVER
Active, Not Recruiting Phase 1/2
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Summary
The primary purpose of this study is to evaluate the safety, tolerability, and dystrophin protein levels in muscle tissue following multiple intravenous (IV) doses of DYNE-251 in participants with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The study consists of 3 periods: a multiple-ascending dose (MAD) / placebo-controlled period (24 weeks), an open-label period (24 weeks) and a long-term extension (LTE) period (288 weeks).
Protocol Amendment History 2 changes
notable Primary completion pushed: 2029-11 -> 2031-09 2026-08-12
minor Completion pushed: 2029-11 -> 2031-09 2026-08-12
Trial Details
NCT Number NCT05524883
Lead Sponsor Dyne Therapeutics
Conditions Duchenne Muscular Dystrophy (DMD)
Enrollment 86 participants
Start Date 2022-08-12
Primary Completion 2031-09 (estimated)
Study Completion 2031-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-11