Clinical Trial

Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment basivarsen (DYNE-101) for the treatment of myotonic dystrophy 1 (DM1).
Protocol Amendment History 6 changes
notable Trial sites expanded: 25 -> 33 locations 2026-08-15
notable Trial sites expanded: 21 -> 24 locations 2026-07-31
notable Trial sites expanded: 11 -> 14 locations 2026-07-01
notable Trial sites expanded: 6 -> 11 locations 2026-06-30
critical Recruitment opened 2026-04-17
notable Trial sites expanded: 0 -> 4 locations 2026-04-17
Trial Details
NCT Number NCT07486934
Lead Sponsor Dyne Therapeutics
Conditions Myotonic Dystrophy Type 1 (DM1), DM1, Myotonic Dystrophy, Steinert Disease, Steinert
Enrollment 150 participants
Start Date 2026-05-14
Primary Completion 2028-07 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-14