Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1
← catalyst calendarNCT07486934 · readout ≤ 712 d
Sponsored by Dyne Therapeutics (industry) · DYN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
150estimated
Sites
34
Countries
Belgium, Denmark, France +7
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 | 2026-05-14 | actual | When the study began enrolling |
| Primary completion | Jul 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Myotonic Dystrophy Type 1 (DM1)
- DM1
- Myotonic Dystrophy
- Steinert Disease
- Steinert
Interventions
- Drug: zeleciment basivarsen (DYNE-101)
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OF5 Times Sit-To-Stand (5×STS) Time
measured Baseline, Week 49
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