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A Randomized, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1

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Trial Profile

A Randomized, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Sep 2026

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At a glance

  • Drugs Zeleciment basivarsen (Primary)
  • Indications Myotonic dystrophy
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms ACHIEVE
  • Sponsors Dyne Therapeutics

Most Recent Events

  • 08 Sep 2026 According to Dyne Therapeutics media release, Topline data from the ACHIEVE REC are planned for Q1 2027.
  • 08 Sep 2026 According to Dyne Therapeutics media release, data from this trial will be presented at the 31st Annual International Congress of the World Muscle Society (WMS) being held September 29, 2026, through October 3, 2026, virtually and in Hiroshima, Japan, as well as the 2026 Annual Meeting of the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) being held September 29, 2026, through October 2, 2026, virtually and in Orlando, Florida.
  • 03 Jun 2026 According to Dyne Therapeutics media release, company announced the completion of enrollment in the registrational expansion cohort (REC) of this Phase 1/2 ACHIEVE trial.

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