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

Phase 3 Recruiting 150 enrolled Dyne Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2026-05-14
Primary completion: 2028-07
Completion: 2029-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	zeleciment basivarsen	Protein / enzyme biologic	—	Intravenous

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

Summary

Timeline

Drugs

Indications