Recruiting
Phase 2

PGN-EDODM1

Sponsor:

PepGen Inc

Code:

NCT07220603

Conditions

Myotonic Dystrophy 1

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

PGN-EDODM1

Study Details

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.

Conditions

Myotonic Dystrophy 1

Study ID

NCT07220603

Start date

Dec 23, 2025

Status verified date

Mar, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PGN-EDODM1

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

Interventions

PGN-EDODM1

Administered by intravenous (IV) infusion

Primary outcome measure

  • Safety and tolerability as assessed by number of participants with Adverse Events (AEs) [ Time Frame: Baseline through Week 108 ]

Central Contacts and Locations

Central contacts

PepGen Patient Advocacy

781-797-0979clinicaltrials@pepgen.com

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Patient Advocacy

781-797-0979clinicaltrials@pepgen.com

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada

Contacts

Patient Advocacy

clinicaltrials@pepgen.com

CIUSSS du Saguenay-Lac-Saint-Jean

Recruiting

Saguenay, Canada

Contacts

Patient Advocacy

clinicaltrials@pepgen.com

More Information

Sponsor

PepGen Inc

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by PepGen Inc on 2026-03-30.