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NCT07220603
An Open-Label Extension Study Evaluating Safety and Pharmacokinetics in Participants With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
Phase 2 trial testing PGN-EDODM1 in Myotonic Dystrophy 1 in 48 participants. Currently enrolling.
1 January 2029
Quick facts
| Lead sponsor | PepGen Inc |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 23 December 2025 |
| Primary completion | 1 January 2029 |
| Estimated completion | 1 January 2029 |
| Sites | 3 locations across Canada |
Drugs / interventions tested
- PGN-EDODM1 — full drug profile →
Conditions studied
- Myotonic Dystrophy 1 — all drugs for Myotonic Dystrophy 1 →
Sponsor
PepGen Inc — full company profile →
Who can join
Eligibility, any sex, with Myotonic Dystrophy 1. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and tolerability as assessed by number of participants with Adverse Events (AEs)
Time frame: Baseline through Week 108
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07220603
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Myotonic Dystrophy 1
Currently open trials in the same condition.
- NCT07385443 — The Spanish National Registry for Myotonic Dystrophy Type 1 · recruiting
- NCT06378216 — Myotonic Dystrophy Type 1 Congenital and Juvenile Form: From Diagnosis to Rehabilitation [MDCJ-NeuBeRe] · recruiting
- NCT03981575 — Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1) · recruiting
Other PepGen Inc trials
Trials by the same sponsor.
- NCT06833931 — A Study of PGN-EDO51 or Placebo in People With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment · Phase 2 · withdrawn
- NCT06079736 — A Study Of PGN-EDO51 In Participants With Duchenne Muscular Dystrophy Amenable To Exon 51-Skipping Treatment · Phase 2 · terminated
- NCT06204809 — Safety, Tolerability, PK, and PD Study of PGN-EDODM1 in Participants With Myotonic Dystrophy Type 1 · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07220603 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PepGen Inc
- Last refreshed: 26 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07220603.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing