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

Recruiting now · Phase 2

Conditions studied: Myotonic Dystrophy 1

In brief

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.

Key facts

Study ID

NCT07220603

Run by

PepGen Inc

People needed

48

Starts

2025-12-23

Expected to finish

2029-01-01

Last updated by the study team

2026-03-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has completed a prior study with PGN-EDODM1

You may not qualify if…

• Abnormal laboratory tests at screening considered clinically significant by the Investigator
• Use of an investigational 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

Where it is running

• University of Calgary — Calgary, Alberta, Canada (enrolling)
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
• CIUSSS du Saguenay-Lac-Saint-Jean — Saguenay, Canada (enrolling)

Full record on ClinicalTrials.gov

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