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RecruitingPhase 3

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

Dyne Therapeutics · NCT07486934

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
150
US sites recruiting
14
Study start
May 14, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: zeleciment basivarsen (DYNE-101); Placebo

Conditions: Myotonic Dystrophy Type 1 (DM1); DM1; Myotonic Dystrophy; Steinert Disease; Steinert

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • UCSD - Altman Clinical and Translational Research Institute

    La Jolla, CA 92037

    Site contact: Christian Farfan · cfarfan@health.ucsd.edu

  • UCLA Medical Center (Department of Neurology)

    Los Angeles, CA 90095

    Site contact: Dennis Fernando · 310-825-3264 · defernando@mednet.ucla.edu

  • Stanford Neuroscience Health Center

    Palo Alto, CA 94304

    Site contact: Anita Chacko · 650-272-8986 · neuromuscularresearch@stanford.edu

  • UF Health: University of Florida Clinical Research Center

    Gainesville, FL 32610

    Site contact: Debbye Landers · 352-273-6181 · debralanders@ufl.edu

  • Rare Disease Research, LLC

    Atlanta, GA 30329

    Site contact: Julia Zhu · 678-883-6897 · julia.zhu@rarediseaseresearch.com

  • IU Health Neuroscience Center

    Indianapolis, IN 46202

    Site contact: Jennifer Terrell · 317-278-6266 · jkramey@iu.edu

  • Kennedy Krieger Institute

    Baltimore, MD 21205

    Site contact: Demaya Starkes · 443-923-3832 · starkesd@kennedykrieger.org

  • Roy Blunt NextGen Precision Health Institute

    Columbia, MO 65211

    Site contact: Heather McHatton · 573-882-7619 · heathermchatton@health.missouri.edu

  • University of Rochester Medical Center

    Rochester, NY 14642

    Site contact: Emily Verdaasdonk · 716-274-3385 · Emily_verdaasdonk@urmc.rochester.edu

  • Rare Disease Research, LLC

    Hillsborough, NC 27278

    Site contact: Hannah Nation · 984-314-2252 · hannah.nation@rarediseaseresearch.com

  • Houston Methodist Neurological Institute

    Houston, TX 77030

    Site contact: Estefania Porras · 346-238-2398 · eporras@houstonmethodist.org

  • The University of Texas Health Science Center at San Antonio

    San Antonio, TX 78229

    Site contact: Tonya D Randolph · 210-450-8460 · Randolpht@uthscsa.edu

  • University of Utah Clinical Neurosciences Center

    Salt Lake City, UT 84132

    Site contact: Michael Papadakis · 8015814474 · m.papadakis@utah.edu

  • Virginia Commonwealth University - Biotech One

    Richmond, VA 23298

    Site contact: Levi Headrick · levi.headrick@vcuhealth.org

Study contacts (from the official record)

  • Dyne Clinical Trials · +1-781-317-1919 · clinicaltrials@dyne-tx.com
Efficacy, Safety, and Tolerability of Zeleciment Basivarsen… (NCT07486934) | Bored Studies