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Trial · NCT07486934

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

NCT07486934, Phase 3, Recruiting, Dyne Therapeutics

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1. Trials, record NCT07486934. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07486934

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1
NCT number
NCT07486934
Status
Recruiting
Phases
Phase 3
Enrollment
150 participants, estimated
Lead sponsor
Dyne Therapeutics
Conditions
Myotonic Dystrophy Type 1 (DM1), DM1, Myotonic Dystrophy, Steinert Disease, Steinert
Interventions
zeleciment basivarsen (DYNE-101), Placebo
First posted
2026-03-23
Last updated
2026-11-06

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary5 Times Sit-To-Stand (5×STS) TimeBaseline, Week 49
SecondaryVideo Hand Opening Time (vHOT) [Middle Finger]Baseline, Week 49
SecondaryQuantitative Muscle Testing (QMT) TotalBaseline, Week 49
SecondaryClinician Global Impression of Change (CGI-C)Week 49
Secondary10-Meter Walk/Run Test (10-MWRT) Velocity (m/s)Baseline, Week 49
SecondaryPatient Global Impression of Change (PGI-C)Week 49
SecondaryDM1-ACTIV^C Total ScoreBaseline, Week 49
SecondaryMyotonic Dystrophy Health Index (MDHI) TotalBaseline, Week 49
SecondaryPatient Global Impression of Severity (PGI-S)Baseline, Week 49
SecondaryClinician Global Impression of Severity (CGI-S)Baseline, Week 49

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07486934

GET https://conductscience.org/api/trials/v1/NCT07486934/registered?page=2