Satellos announced the commencement of a Phase 2A trial of SAT-3247 (NCT07287189) in ambulatory patients with Duchenne aged 7 to 10 years. In this trial, two doses of SAT-3247 will be studied over 12 weeks in a randomized, double-blind, placebo-controlled, intraweek regimen to determine the optimal dose, safety, tolerance, and preliminary efficacy. Learn More: Satellos Receives FDA and International Clearance to Commence Pediatric Phase 2 Testing of SAT-3247 for Duchenne Muscular Dystrophy
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What is SAT-3247 Phase 2A Clinical Trial?
This is a global phase 2a trial of SAT-3247 in ambulatory DMD patients aged ≥ 7 and < 10 years. The trial will study two doses of SAT-3247 in a randomized, double-blind, placebo-controlled weekday regimen for 12 weeks to determine the optimal dose, safety, tolerability, and preliminary efficacy. One dose of SAT-3247 and placebo will be studied in the US and Canada; two doses of SAT-3247 and placebo will be studied in UK, EU, Serbia, and Australia.
Enrollment of up to 51 ambulatory DMD participants aged ≥ 7 and < 10 years of age is planned globally. Randomization will be stratified by baseline corticosteroid regimen and prior DMD concomitant medications.
Each participant will receive once daily doses of SAT-3247 or matched placebo for 12 weeks.
Participants will be screened within 28 days before initiating dosing of investigational product at Baseline. Following the Screening period, participants will complete a Baseline visit (Visit 2), a follow-up phone call at Week 1, and visits at Week 4 (Visit 3), Week 8 (Visit 4), and Week 12 (Visit 5).
SAT-3247 Phase 2A – NCT07287189
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Dose Comparison and Exploratory Efficacy Study of Orally Administered SAT-3247 in Ambulatory DMD Patients.
Study Start (Actual): 2025-12-08
Primary Completion (Estimated): 2026-03-31
Study Completion (Estimated): 2026-06-30
Number of Participants (Estimated): 51
Study Type: Interventional
Location: USA, Australia, Canada, Serbia, United Kingdom
Ages Eligible for Study: 7 Years to 9 Years (Male Child)
Principal inclusion and exclusion criteria. – NCT07287189 –
How to Participate in the SAT-3247 Phase 2A Clinical Trial
To participate in the SAT-3247 Phase 2A clinical trial, you can use the contact information below. Learn More: How to Participate in Clinical Trials for Duchenne (DMD)?
Contact information for individuals who can answer questions about participating in the study, as well as information about where the study is being conducted, will be published.
Read More: Clinical Trials for Duchenne (List of All Researches)
