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NOT YET RECRUITING
NCT07486934
PHASE3
Efficacy, Safety, and Tolerability of DYNE-101 in Participants With Myotonic Dystrophy Type 1
Sponsor: Dyne Therapeutics
View on ClinicalTrials.gov
Summary
The purpose of the study is to assess the efficacy, safety, and tolerability of DYNE-101 for the treatment of myotonic dystrophy 1 (DM1).
Official title: A Phase 3, Randomized, Double-Blind, 48-Week Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-04
Completion Date
2029-01
Last Updated
2026-03-23
Healthy Volunteers
No
Interventions
DRUG
DYNE-101
Administered by IV infusion
DRUG
Placebo
Administered by IV infusion