Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1
← catalyst calendarNCT05481879 · readout ≤ 1,077 d
Sponsored by Dyne Therapeutics (industry) · DYN — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
116estimated
Sites
20
Countries
Australia, France, Germany +5
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 | 2022-09-05 | actual | When the study began enrolling |
| Primary completion | Jul 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2022-08-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myotonic Dystrophy Type 1 (DM1)
Interventions
- Drug: DYNE-101
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFMAD Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
measured Through study completion, up to Week 217
Dose Expansion Cohorts: Change From Baseline in Myotonia as Measured by Video Hand Opening Time (vHOT)
measured Baseline up to Week 25
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