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Phase 2 Study of SAT-3247 for Duchenne Muscular Dystrophy

This study is testing a drug called SAT-3247 in boys with Duchenne Muscular Dystrophy (DMD) who are still able to walk. SAT-3247 is designed to help muscle regeneration and improve muscle function. We are looking for boys aged 7 to 9 years old who have a confirmed DMD diagnosis and are on a stable dose of steroids. The main goals are to see if SAT-3247 is safe and well-tolerated, and to find the best dose. We will also look at whether it helps improve muscle strength. The study plans to enroll up to 51 participants globally, but the current recruitment status is unclear.

Study design
This is a Phase 2a study, meaning it's an early-stage trial. It's randomized, double-blind (neither you nor the doctors will know if you're getting SAT-3247 or a placebo), and placebo-controlled, involving up to 51 participants.
What's involved
You would take SAT-3247 or a matching placebo as an oral tablet once daily for 12 weeks. There will be a screening visit, a baseline visit, a phone call at Week 1, and in-person visits at Week 4, Week 8, and Week 12.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for safety, tolerability, and muscle strength are measured at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07287189

Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients

Recruiting
PHASE2Ages 7–9InterventionalTreatment
Satellos Bioscience, Inc.
~51 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:SAT-3247Placebo

At a glance

Recruiting sites
18 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of SAT-3247
Measured over 12 weeks in Part 1 and up to 12 months in part 2
+2 more outcomes measured

Conditions

Duchenne Muscular Dystrophy
Duchenne
DMD
Neuromuscular Diseases
Muscular Dystrophies

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Duchenne Muscular Dystrophy

NCT07287189

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital at Westmead

    Westmead, New South Wales, Australiastudy coordinator listed

    Recruiting

  • Children's Hospital Eastern Ontario

    Ottawa, Ontario, Canadastudy coordinator listed

    Recruiting

  • Clinic of Neurology and Psychiatry for Children and Youth

    Belgrade, Serbia, Serbiastudy coordinator listed

    Not yet recruiting

  • Colorado Children's

    Aurora, Coloradostudy coordinator listed

    Recruiting

  • Great Ormond Street

    London, UK, United Kingdomstudy coordinator listed

    Recruiting

  • Hôpital De La Citadelle (CHR)

    Liège, Liège, Belgiumstudy coordinator listed

    Recruiting

  • Hospital Infantil i Hospital de la Dona

    Barcelona, Spainstudy coordinator listed

    Recruiting

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Basque Country, Spainstudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Satellos Chief Medical Officer · STUDY_DIRECTOR · Satellos Bioscience, Inc.

Who to contact

Satellos Medical Information
[email protected]
+1 647-660-1780
Email the study team

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Eligibility criteria

Inclusion

Has a definitive diagnosis of DMD based on documented clinical findings and prior genetic testing with a confirmed mutation in the DMD gene.
Male DMD patients who are ambulatory and aged ≥ 7 to \< 10 years at the time of screening.
Stable dose of systemic glucocorticoids (i.e., prednisolone, deflazacort, or vamorolone) according to the standard of care for ≥ 3 months prior to the Screening Visit and for the duration of the trial. Patients who are not receiving glucocorticosteroids are also eligible if stopped ≥ 3 months prior to the Screening Visit.
Stable doses of prescription medicines including ACE inhibitors, β-blockers, and diuretics (excluding glucocorticosteroids) and over-the-counter medicines and/or herbal supplements for supportive care ≥ 1 month prior to the Screening Visit and for the duration of the trial.
Participants that have previously received delandistrogene moxeparvovec (brand name Elevidys) either in a prior clinical trial or in the commercial setting \> 18 months prior to screening whose muscle function tests have stabilized or demonstrated decline ≥ 3 months prior to Screening, as determined by investigator and documented in chart notes, will be eligible.
Participants that have previously received an exon skipper \> 6 months prior to Screening whose muscle function tests have stabilized or demonstrated decline ≥ 3 months prior to Screening, as determined by investigator and documented in chart notes, will be eligible.
Participants receiving a stable dose of givinostat (brand name Duvyzat) for at least 18 months or longer prior to the Screening Visit will be eligible. Participants unable to tolerate givinostat who discontinued treatment before 18 months are eligible to enroll if date of last dose is ≥ 30 days from the Screening date. Givinostat should not be discontinued, if tolerated, to meet study entry criteria.
Participants that have received prior treatment with an investigational gene therapy product (other than delandistrogene moxeparvovec) ≥ 24 months prior to the Screening Visit.
If participating in a physical therapy/strength training regimen, must be stable for ≥ 2 months prior to the Screening Visit and for the duration of the trial.

Exclusion

Ambulatory patients expected to experience loss of ambulation within ≤ 12 months.
Participants for whom MRI or open muscle biopsy are contraindicated.
Evidence of significant hepatic dysfunction, defined as GLDH \> 2X upper limit of normal (ULN) at the Screening Visit.
Impaired cardiac function defined as a left ventricular ejection fraction of \< 50% on screening cardiac assessments (echocardiogram or MRI) or evidence of symptomatic cardiomyopathy.
A forced vital capacity \< 60% predicted at the Screening Visit.
Ongoing participation in any other therapeutic clinical trial or follow-up study for a therapeutic intervention
Consumption of grapefruit juice or grapefruit containing products
Severe behavioural or cognitive problems that preclude participation in the study, in the opinion of the investigator.

What this trial measures

  • Safety of SAT-324712 weeks in Part 1 and up to 12 months in part 2

    Occurrence of treatment emergent adverse events and relationship to investigational product

  • Tolerability of SAT-324712 weeks in Part 1 and up to 12 months in Part 2

    occurrence of clinically significant changes in physical exam, clinical laboratory measures, vital signs, and ECG

  • SAT-3247 effects on muscle strength12 weeks in Part 1 and up to 12 months in Part 2

    change from baseline in muscle force as determined by dynamometry