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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 Mar 2026

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At a glance

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

Most Recent Events

  • 02 Mar 2026 According to a Dyne Therapeutics media release, company have added seven new sites since September to the ACHIEVE trial of z-basivarsen in DM1 and completion of enrollment is expected in the second quarter. 60 participants will be enrolled till second quarter of 2026.
  • 23 Feb 2026 According to a Dyne Therapeutics media release, data from this study will be presented at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference being held March 8-11, 2026, in Orlando, FL, and virtually.
  • 05 Nov 2025 According to a Dyne Therapeutics media release, Dyne intends to use data from the REC and from the already enrolled patients in the multiple ascending dose (MAD) and ongoing long-term extension portions of the ACHIEVE trial to support a potential submission for Accelerated Approval in the U.S. in early Q3 2027.

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