Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)
← catalyst calendarNCT05291091 · readout ≤ 42 d
Sponsored by Edgewise Therapeutics, Inc. (industry) · EWTX — their whole pipeline →. With Medpace, Inc., ImagingNMD, SYSNAV.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
244actual
Sites
51
Countries
Australia, Belgium, Denmark +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-11-10 | actual | When the study began enrolling |
| Primary completion | Sep 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2022-03-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Becker Muscular Dystrophy
Interventions
- Drug: Sevasemten 10 mg
- Drug: Sevasemten 5 mg
- Drug: Sevasemten 12.5 mg
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of adverse events in those treated with sevasemten or placebo
measured 12 months (CANYON Cohorts 1, 2, 4, 5), 18 months (GRAND CANYON Cohort 6)
Severity of adverse events in those treated with sevasemten or placebo
measured 12 months (CANYON Cohorts 1, 2, 4, 5), 18 months (GRAND CANYON Cohort 6)
Change from Baseline in serum Creatine Kinase
measured 12 Months (CANYON Cohorts 1, 2)
Change from Baseline in the North Star Ambulatory Assessment scale
measured 18 months (GRAND CANYON Cohort 6)
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