Actively Recruiting
Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1
Led by Dyne Therapeutics · Updated on 2026-05-06
150
Participants Needed
5
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myotonic dystrophy type 1 confirmed by genetic testing with trinucleotide repeat size greater than 100
- Ability to walk 10 meters and complete 5 times sit to stand independently (supports below the ankle allowed)
- Body mass index (BMI) less than 35 kg/m²
You will not qualify if you...
- Known diagnosis of congenital myotonic dystrophy
- History of major surgery within 12 weeks prior to screening, except for implanted pacemaker or defibrillator
- Use of glucagon-like peptide 1 (GLP-1) agonist medications including semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide within 5 half-lives before screening assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Rare Disease Research, LLC
Atlanta, Georgia, United States, 30329
Actively Recruiting
2
Rare Disease Research, LLC
Hillsborough, North Carolina, United States, 27278
Actively Recruiting
3
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
4
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka-Shi, Osaka, Japan, 560-8552
Actively Recruiting
5
Yamaguchi University Hospital
Ube-Shi, Yamaguchi, Japan, 755-8505
Actively Recruiting
Research Team
D
Dyne Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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