NCT07486934 Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1
| NCT ID | NCT07486934 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Dyne Therapeutics |
| Condition | Myotonic Dystrophy Type 1 (DM1) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-05-14 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2026-05-14 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07486934 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Myotonic Dystrophy Type 1 (DM1). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07486934 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT07486934 currently recruiting?
Yes, NCT07486934 is actively recruiting participants. Contact the research team at clinicaltrials@dyne-tx.com for enrollment information.
Where is the NCT07486934 trial being conducted?
This trial is being conducted at La Jolla, United States, Los Angeles, United States, Palo Alto, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT07486934 clinical trial?
NCT07486934 is sponsored by Dyne Therapeutics. The trial plans to enroll 150 participants.