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An Open-label Long-term Follow-up Study of SAT-3247 for Participants With Duchenne Muscular Dystrophy Including Those Who Participated in SAT-3247-CL-101

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Aug 30, 2026 → Sep 30, 2027
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Satellos Bioscience, Inc.

Record History

  1. Minor Secondary endpoints: details revised at 4 of 4 entries
  2. Notable Primary and study completion pushed from Aug 30, 2026 to Sep 30, 2027 Primary endpoint(s) modified · Enrollment increased: 10 → 30 participants · Trial sites expanded: 2 → 5 locations · 2 more Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 10 → 30 participants
    • Trial sites expanded: 2 → 5 locations
    • Eligibility criteria expanded, about 293 words
    • Secondary endpoints: 3 to 4
  3. Minor Study sites: 1 to 2 Study title expanded, about 8 wordsv4 Show 1 more changeShow less
    • Study title expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  4. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Jul 15, 2025 to Aug 20, 2025 · Site contact updatedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jul 15, 2025 to Aug 20, 2025
    • Site contact updated
  5. Notable Start date: May 1, 2025 to Jul 15, 2025 Primary endpoint revised · Primary and study completion dates: Jun 30, 2026 to Aug 30, 2026v2 Show 2 more changesShow less
    • Primary endpoint revised
    • Primary and study completion dates: Jun 30, 2026 to Aug 30, 2026

    See this version in full on ClinicalTrials.gov ↗

  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an open-label long-term safety and efficacy study of orally administered SAT-3247 in patients with DMD including those who previously participated in SAT-3247-CL-101. The study will assess the long-term safety, tolerability and potential efficacy of long-term dosing of orally administered SAT-3247 60 mg in a 5-days on/2-days off (i.e. weekday dosing) regimen in an open-label design through 11 months (Group A) or 12 months (Group B), respectively. The study will enroll up to 30 participants, including up to 5 who previously participated in the SAT-3247-CL-101 study.
Trial Details
NCT Number NCT06867107
Lead Sponsor Satellos Bioscience, Inc.
Conditions Duchenne Muscular Dystrophy (DMD)
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov