---
title: An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
nct_id: NCT07220603
overall_status: RECRUITING
phase: PHASE2
sponsor: PepGen Inc
study_type: INTERVENTIONAL
primary_condition: Myotonic Dystrophy 1
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07220603.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07220603"
ct_last_update_post_date: 2026-03-30
last_seen_at: "2026-05-12T06:16:17.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)

**Official Title:** An Open-Label Extension Study Evaluating Safety and Pharmacokinetics in Participants With Myotonic Dystrophy Type 1 (FREEDOM-OLE)

**NCT ID:** [NCT07220603](https://clinicaltrials.gov/study/NCT07220603)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 48
- **Lead Sponsor:** PepGen Inc
- **Conditions:** Myotonic Dystrophy 1
- **Start Date:** 2025-12-23
- **Completion Date:** 2029-01
- **CT.gov Last Update:** 2026-03-30

## Brief 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.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Participant has completed a prior study with PGN-EDODM1

Exclusion Criteria:

* 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
```

## Arms

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

## Interventions

- **PGN-EDODM1** (DRUG) — Administered by intravenous (IV) infusion

## Primary Outcomes

- **Safety and tolerability as assessed by number of participants with Adverse Events (AEs)** _(time frame: Baseline through Week 108)_

## Locations (3)

- University of Calgary, Calgary, Alberta, Canada — _RECRUITING_
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada — _RECRUITING_
- CIUSSS du Saguenay-Lac-Saint-Jean, Saguenay, Canada — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of calgary|calgary|alberta|canada` — added _(2026-05-12)_
- `locations.ottawa hospital research institute|ottawa|ontario|canada` — added _(2026-05-12)_
- `locations.ciusss du saguenay-lac-saint-jean|saguenay||canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07220603.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07220603*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*