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

Study acronym: DELIVER
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 9 months later Nov 2029 → Sep 2031
See other at-risk trials from Dyne Therapeutics

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Nov 2029 to Sep 2031
    • Secondary endpoints revised (24)
    v29
  2. 2 versions Re-verified since Jul 7, 2025, no change to tracked fieldsv27-v28
  3. Study sites: 33 to 30v26
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 88 to confirmed 86
    • Site details revised at 33 of 33 sites
    v25
  5. Study sites: 30 to 33v24
Show 22 earlier versionsHide 22 earlier versions
  1. Primary and study completion dates: Nov 2026 to Nov 2029
    • Eligibility criteria revised
    • Secondary endpoints revised (24)
    v23
  2. Study sites: 29 to 30v22
  3. Study sites: 28 to 29v21
  4. Site contacts updated at 1 of 28 sitesv20
  5. Study sites: 26 to 28v19
  6. Study sites: 25 to 26v18
  7. Site contacts updated at 1 of 25 sitesv17
  8. Enrollment target: 48 to 88
    • Study sites: 24 to 25
    • Secondary endpoints: 20 to 24
    • Eligibility criteria expanded, about 5 words
    v16
  9. Study sites: 21 to 24v15
  10. Study sites: 20 to 21v14
  11. Study sites: 19 to 20v13
  12. Study sites: 18 to 19v12
  13. Study sites: 17 to 18v11
  14. Study sites: 16 to 17v10
  15. Study sites: 14 to 16
    • Secondary endpoints revised (20)
    v9
  16. Study sites: 13 to 14v8
  17. Enrollment target: 46 to 48
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: 19 to 20
    v7
  18. Study sites: 10 to 13v6
  19. Site contacts updated at 1 of 10 sitesv5
  20. Study sites: 5 to 10v4
  21. Study sites: 3 to 5v3
  22. Study sites: 2 to 3v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05524883
Lead Sponsor Dyne Therapeutics
Conditions
(from sponsor)		 Duchenne Muscular Dystrophy (DMD)
Related terms Muscular Dystrophy, Duchenne
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov