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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