Actively Recruiting

Phase 2
Age: 16Years - 65Years
All Genders
NCT06667453

A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1

Led by PepGen Inc · Updated on 2026-04-28

24

Participants Needed

8

Research Sites

115 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to learn about the effects of an investigational medicine, PGN-EDODM1, to see how safe and tolerable multiple administrations of PGN-EDODM1 are for people with myotonic dystrophy type 1 (DM1) compared to placebo.

CONDITIONS

Official Title

A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1

Who Can Participate

Age: 16Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of myotonic dystrophy type 1 with at least 100 CTG repeats in the DMPK gene
  • Presence of muscle stiffness (myotonia)
  • Sufficient muscle mass in both tibialis anterior muscles to safely perform a needle biopsy
  • Body mass index (BMI) below 35.0 kg/m²
Not Eligible

You will not qualify if you...

  • Congenital myotonic dystrophy type 1
  • Any clinically significant condition affecting study safety assessments
  • Clinically significant abnormal lab tests at screening
  • Use of medications specifically for myotonia within 2 weeks prior to screening
  • Forced vital capacity (FVC) under 40%
  • Use of any investigational drug, device, or product within 30 days or 5 half-lives of the study drug before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

University of Calgary

Calgary, Alberta, Canada, T2N 4Z6

Actively Recruiting

2

Ottawa Hospital Research Institute (OHRI)

Ottawa, Ontario, Canada

Actively Recruiting

3

CIUSSS du Saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Actively Recruiting

4

Montreal Neurological Institute

Montreal, Quebec, Canada, H3A 2B4

Actively Recruiting

5

Pacific Clinical Research Network Auckland

Takapuna, Auckland, New Zealand, 0622

Active, Not Recruiting

6

Salford Royal Hospital

Salford, England, United Kingdom

Actively Recruiting

7

University College London Hospitals NHS Foundation Trust

London, UK, United Kingdom

Actively Recruiting

8

Newcastle Upon Tyne Hospitals

Newcastle upon Tyne, United Kingdom, NE7 7DN

Actively Recruiting

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Research Team

P

PepGen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 | DecenTrialz