Clinical trial
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of…
NCT05096221 · Sarepta Therapeutics, Inc., Industry · Completed
Key facts
| NCT number | NCT05096221 |
|---|---|
| Title | A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD) |
| Official title | A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK) |
| Acronym | EMBARK |
| Lead sponsor | Sarepta Therapeutics, Inc., Industry |
| Collaborators | Hoffmann-La Roche Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Duchenne Muscular Dystrophy |
| Intervention type | Genetic |
| Interventions | delandistrogene moxeparvovec, placebo |
| Enrollment | 126 |
| Start date | Oct 27, 2021 |
| Primary completion | Oct 4, 2023 |
| Completion | Oct 25, 2024 |
| First posted | Oct 27, 2021 |
| Last update posted | Jul 8, 2025 |
| Countries | Belgium, Germany, Hong Kong, Italy, Japan, Spain, Taiwan, United Kingdom, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: