🏛️ Verified NIH Record • Updated 2026-08-14

Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1 (NCT07486934)

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

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Dyne Therapeutics

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: UCSD - Altman Clinical and Translational Research Institute — La Jolla, California

Age range: 16 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (34 Sites)

Showing the first 25 of 34 sites.

  • UCSD - Altman Clinical and Translational Research Institute — La Jolla, California
  • UCLA Medical Center (Department of Neurology) — Los Angeles, California
  • Rare Disease Research, LLC — Atlanta, Georgia
  • IU Health Neuroscience Center — Indianapolis, Indiana
  • Roy Blunt NextGen Precision Health Institute — Columbia, Missouri
  • Rare Disease Research, LLC — Hillsborough, North Carolina
  • The University of Texas Health Science Center at San Antonio — San Antonio, Texas
  • University of Utah Clinical Neurosciences Center — Salt Lake City, Utah
  • Virginia Commonwealth University - Biotech One — Richmond, Virginia
  • UZA — Edegem,
  • UZ Leuven — Leuven,
  • Rigshospitalet, (Neuromuscular Clinic and Research Unit, Department 8077) — Copenhagen,
  • AP-HP, Hôpital Raymond-Poincaré — Garches,
  • CHU Marseille - Hôpital de la Timone (APHM) — Marseille,
  • CHU de Nantes - Hôtel-Dieu — Nantes,
  • Pitié-Salpêtrière Hospital — Paris,
  • CHU de Toulouse - Hôpital Pierre-Paul Riquet — Toulouse,
  • LMU Klinikum der Universität München Neurologische Klinik und Poliklinik Friedrich-Baur-Institut Campus Innenstadt — Munich, Bavaria
  • Universitätsklinikum Bonn AöR Zentrum für Neurologie Klinik für Neuroimmunologie und Neuromuskuläre Erkrankungen — Bonn, North Rhine-Westphalia
  • Charité Universitätsmedizin Berlin Campus-Buch Muscle Research Unit — Berlin, State of Berlin
  • Centro Clinico Nemo Brescia, Fondazione Serena ETS — Gussago, Brescia
  • Centro Clinico Nemo Milano, Fondazione Serena ETS — Milan, Milano
  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Department of Women's, Child and Public Health Sciences - UOC Neuropsichiatria Infantile — Roma, Roma
  • Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Neurologia — Roma, Roma
  • Niigata National Hospital, National Hospital Organization — Kashiwazaki, Niigata

📞 Contact the Study Coordinator

Phone: (781) 317-1919

Email: clinicaltrials@dyne-tx.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗