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NCT07008469

Global Open-Label Extension Study of Del-desiran for the Treatment of DM1

Enrolling by Invitation
PHASE3Ages 16+InterventionalTreatment
Avidity Biosciences, Inc.
~230 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Del-desiran (AOC 1001)

At a glance

Recruiting sites
0 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
TEAEs
Measured over From enrollment to the end of treatment at 4 years

Conditions

Myotonic Dystrophy Type 1
DM1
Myotonic Dystrophy
Myotonia
Myotonic Dystrophy 1
Myotonic Disorders
Steinert Myotonic Dystrophy
Steinert Disease

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Where it's being run

35 sites across 26 states
Japan3
California2
Florida2
North Carolina2
Ohio2
Denmark2
Netherlands2
United Kingdom2

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Completion of any prior AOC 1001 studies with satisfactory completion of dosing and follow-up assessments and satisfactory compliance with the protocol requirements of the parent study, as determined by the Investigator.
Clinical and genetic diagnosis of DM1 and clinically significant hand myotonia.

Exclusion

Breastfeeding, pregnancy, or intent to become pregnant during the study.
Unwilling to comply with contraceptive requirements.
Any new conditions or worsening of existing condition that in the opinion of the Investigator would make the participant unsuitable for the study.
Breastfeeding, pregnancy, or intent to become pregnant during the study
Unwilling to comply with contraceptive requirements
Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study
Diabetes that is not adequately controlled
History of decompensated heart failure within 3 months of screening. Participants with preexisting pacemaker/ICD are not excluded
Body Mass Index \> 35 kg/m2 at Screening
Recently treated with an investigational drug or biological agent

What this trial measures

  • TEAEsFrom enrollment to the end of treatment at 4 years

    Incidence of treatment emergent adverse events