RecruitingPhase 3NCT07486934

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

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


Sponsor

Dyne Therapeutics

Enrollment

150 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called zeleciment basivarsen (DYNE-101) for people with dm1, myotonic dystrophy, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 16 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGzeleciment basivarsen (DYNE-101)

Administered by IV infusion

DRUGPlacebo

Administered by IV infusion


Locations(6)

Rare Disease Research, LLC

Atlanta, Georgia, United States

Roy Blunt NextGen Precision Health Institute

Columbia, Missouri, United States

Rare Disease Research, LLC

Hillsborough, North Carolina, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka-Shi, Osaka, Japan

Yamaguchi University Hospital

Ube-Shi, Yamaguchi, Japan

View Full Details on ClinicalTrials.gov

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NCT07486934


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