Phase 2 Muscular Dystrophy Trial, Recruiting NCT05481879 Sponsor: Dyne Therapeutics Condition: Muscular Dystrophy
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Phase 2 Muscular Dystrophy Trial, Recruiting

NCT05481879
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with a type of Myotonic Dystrophy Type 1 (DM1) where the genetic repeat causing the condition is larger than 100 repeats.
  • Your muscle symptoms from DM1 started when you were 12 years old or older.
  • You have noticeable muscle stiffness (myotonia), meaning it takes you at least 2 seconds to fully open your hand, as assessed by the study doctor.
  • You have measurable strength in your hand grip and in lifting your foot upward at the ankle.
  • You are able to walk a short distance, climb and descend stairs (for certain groups in the study), and stand up from a chair 5 times in a row — all without using walking aids like canes, walkers, or leg braces.

Who may not be able to join:

  • You have had a major surgery in the last 12 weeks, or you are expected to have one (such as having a heart device implanted) during the study.
  • You have a history of a severe allergic reaction (anaphylaxis).
  • You have another health condition, unrelated to DM1, that significantly affects your ability to walk or take part in physical assessments.
  • You have recently taken medications that can reduce muscle stiffness (myotonia), within a certain timeframe before your screening visit (confirm with trial site).
  • Your heart's electrical activity (measured by an ECG) shows certain abnormalities, including a reading above specific limits or a significant heart conduction problem, as judged by the study doctor.
  • Your lung function test shows that your breathing capacity is below 50% of what is expected for someone your age and size.
  • You have had a biopsy of a specific muscle in your lower leg (tibialis anterior) within the past 3 months, or you plan to have one during the study for reasons unrelated to this trial.
  • You have had a history of suicidal behaviour, a suicide attempt, or certain levels of suicidal thoughts within the past 6 months, or the study doctor considers you to be at significant risk.
  • You have recently taken certain diabetes or weight-management medications (such as semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide) within a specific timeframe before your screening visit.
  • Significant weight loss during the study may affect your eligibility or continued participation, as it could impact how the medication is dosed and how results are measured (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Note: This is not a complete list — additional criteria may apply. This information is provided for general understanding only and is not medical advice.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +1-781-317-1919

Australian sites

St. Vincent's Hospital, Fitzroy, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Dyne Therapeutics
Registry
ClinicalTrials.gov
Start date
5 September 2022
Est. completion
1 July 2029

Where this trial is recruiting

🇦🇺 Australia 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇿 New Zealand 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

MAD Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); Dose Expansion Cohorts: Change From Baseline in Myotonia as Measured by Video Hand Opening Time (vHOT)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov