Safety, Tolerability, PK, and PD Study of PGN-EDODM1 in Participants With Myotonic Dystrophy Type 1
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
24actual
Sites
12
Countries
Canada, United Kingdom, 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 | 2023-12-12 | actual | When the study began enrolling |
| Primary completion | 2025-10-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-28 | actual | The whole study's end, after follow-up |
| First posted | 2024-01-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-13 | 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 1
Interventions
- Drug: PGN-EDODM1 for infusion
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFNumber of participants with Adverse Events, Serious Adverse Events, with abnormal Clinical Laboratory tests, abnormal ECGs, and abnormal Vital Signs
measured Baseline to Week 16
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