Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)
← catalyst calendarNCT07608432 · readout ≤ 1,594 d
Sponsored by Dyne Therapeutics (industry) · DYN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
90estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Jun 2026 | estimated | When the study began enrolling |
| Primary completion | Dec 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Duchenne Muscular Dystrophy (DMD)
- Muscular Dystrophy, Duchenne
- Muscular Dystrophy (DMD)
- DMD
- Muscular Dystrophies
- Muscular Dystrophy in Children
- Muscular Dystrophy, Duchenne Type
- Muscular Dystrophy, Duchenne and Becker Types
- Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)
- Genetic Disease, Inborn
- Genetic Disease, X-Linked
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Neuromuscular Diseases (NMD)
Interventions
- Drug: Zeleciment Rostudirsen (DYNE-251)
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFRise From Floor (RFF) velocity
measured Baseline, Week 73
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