🔎 Trials Near Me

Home › Myotonic Dystrophy › NCT07486934

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

RecruitingPhase 3

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

Who can join

Ages 16 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Diagnosis of DM1 confirmed by molecular genetics with trinucleotide repeat size greater than (\>) 100. Historical results from clinical testing are acceptable.
* Able to walk 10 meters and complete 5 times sit to stand independently (inserts or supports that don't go above the ankle are allowed).
* Body mass index (BMI) less than (\<) 35 kilograms per meter square (kg/m\^2).

Exclusion Criteria:

* A known diagnosis of congenital DM1.
* History of major surgical procedure (based on Investigator judgment) within 12 weeks prior to the start of screening, with the exception of implanted pacemaker or defibrillator.
* Use of glucagon-like peptide 1 (GLP-1) agonist/incretin medications including semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide within a period of 5 half-lives of the medication prior to performing screening assessments.

Note: Other inclusion and exclusion criteria may apply.

About the study

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).

What is being tested

Sponsor: Dyne Therapeutics · Participants: 150 · Started: May 14, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07486934

Locations in the U.S.

CaliforniaUCSD - Altman Clinical and Translational Research Institute, La Jolla
UCLA Medical Center (Department of Neurology), Los Angeles
Stanford Neuroscience Health Center, Palo Alto
GeorgiaRare Disease Research, LLC, Atlanta
IndianaIU Health Neuroscience Center, Indianapolis
MissouriRoy Blunt NextGen Precision Health Institute, Columbia
New YorkUniversity of Rochester Medical Center, Rochester
North CarolinaRare Disease Research, LLC, Hillsborough
TexasThe University of Texas Health Science Center at San Antonio, San Antonio
UtahUniversity of Utah Clinical Neurosciences Center, Salt Lake City
VirginiaVirginia Commonwealth University - Biotech One, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.