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

RecruitingPhase 3Ages 16 Years - anyAllDyne Therapeutics
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • zeleciment basivarsen (DYNE-101)
  • Placebo
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Where

43 sites
UCSD - Altman Clinical and Translational Research Institute
La Jolla, United States
UCLA Medical Center (Department of Neurology)
Los Angeles, United States
Stanford Neuroscience Health Center
Palo Alto, United States
UF Health: University of Florida Clinical Research Center
Gainesville, United States
Rare Disease Research, LLC
Atlanta, United States
IU Health Neuroscience Center
Indianapolis, United States
Kennedy Krieger Institute
Baltimore, United States
Roy Blunt NextGen Precision Health Institute
Columbia, United States

โ€ฆand 35 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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