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

NCT07008469 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-04-23

No results posted yet for this study

Summary

A Global Phase 3 Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Intravenous Delpacibart Etedesiran (abbreviated del-desiran, formerly AOC 1001) for the Treatment of Myotonic Dystrophy Type 1

Conditions

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

Interventions

DRUG

Del-desiran (AOC 1001)

Del-desiran will be administered by intravenous (IV) infusion.

Sponsors & Collaborators

  • Avidity Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2030-08-31
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07008469 on ClinicalTrials.gov