ClinicalTrials.gg
RecruitingNCT07220603Updated Mar 30, 2026

An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)

A Phase 2 interventional study of PGN-EDODM1 in Myotonic Dystrophy 1, sponsored by PepGen Inc. Recruiting at 3 sites in Canada. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by PepGen Inc · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Sex
All
01

Study summary

The purpose of this study is to learn about the long-term safety and tolerability of PGN-EDODM1 in participants with myotonic dystrophy type 1 (DM1) who have completed a prior study with PGN-EDODM1.

02

Conditions studied

  • Myotonic Dystrophy 1

Keywords

  • DM1
  • Myotonic Dystrophy 1
  • Myotonic Dystrophy
  • PepGen
  • PGN-EDODM1
  • Myotonic Muscular Dystrophy
  • Steinhert's Disease
  • Myotonic Dystrophies
  • Genetic Diseases, Inborn
  • Neuromuscular Diseases
  • Nervous System Diseases
  • Musculoskeletal Diseases
  • Myotonic Disorders
  • Muscular Disorders, Atrophic
  • Heredodegenerative Disorders, Nervous System
  • Muscular Diseases
03

In context

Myotonic Dystrophy

126 studies on the registry are indexed under Myotonic Dystrophy; 50 are open to participants now.

This study's planned enrollment of 48 is above the median of 40 across 67 interventional studies indexed under Myotonic Dystrophy.

Browse Myotonic Dystrophy studies →

Lead sponsor

PepGen Inc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant has completed a prior study with PGN-EDODM1

Exclusion criteria

Exclusion Criteria:

  • Abnormal laboratory tests at screening considered by the Investigator
  • Use of an drug (other than PGN-EDODM1), device, or product, within 30 days or 5 half-lives of the study drug (whichever is longer) prior to study entry
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    PGN-EDODM1

    Participants will receive doses of PGN-EDODM1 once every 4 weeks (Q4W)

    Drug: PGN-EDODM1

Interventions

  • DrugPGN-EDODM1

    Administered by intravenous (IV) infusion

06

What researchers measure

Primary outcomes

  1. Safety and tolerability as assessed by number of participants with Adverse Events (AEs)

    Time frame: Baseline through Week 108

07

Study locations

3 of 3 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for Jan 2029, 37 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2025
First posted
Oct 24, 2025
StartActual
Dec 23, 2025
Primary completionEst.
Jan 2029
CompletionEst.
Jan 2029
Last update
Mar 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07220603
Lead sponsor
PepGen Inc
Responsible party
Sponsor
First posted
Oct 24, 2025
Start date
Dec 23, 2025
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Mar 30, 2026

Study contacts

PepGen Patient Advocacy
Contact
clinicaltrials@pepgen.com
781-797-0979

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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