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Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)
NCT05291091 · View on ClinicalTrials.gov ↗
Study Summary
A study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. CANYON and GRAND CANYON are fully enrolled.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sevasemten 10 mg
- DRUG Sevasemten 5 mg
- DRUG Sevasemten 12.5 mg
Study Locations (20)
California
- UC San Diego — La Jolla
- UCLA Medical Center — Los Angeles
- UC Irvine Medical Center — Orange
- Stanford Neuroscience Health Center — Palo Alto
- UC Davis Medical Center — Sacramento
Arkansas
- Arkansas Children's Hospital — Little Rock
Colorado
- UC Denver — Aurora
Florida
- University of Florida — Gainesville
Georgia
- Rare Disease Research — Atlanta
Illinois
- Northwestern University — Chicago
Indiana
- Indiana University School of Medicine — Indianapolis
Iowa
- University of Iowa — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2022-11-10 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05291091
The ClinicalTrials.gov registry entry for NCT05291091 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edgewise Therapeutics, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Becker Muscular Dystrophy appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05291091 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Arkansas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05291091 about?
NCT05291091 is a clinical study titled "Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)". A study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, pla...
What is the current status of trial NCT05291091?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2022-11-10. Estimated completion is 2026-09.
What conditions does trial NCT05291091 study?
This clinical trial studies the following conditions: Becker Muscular Dystrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05291091?
The interventions under investigation include: Placebo (DRUG), Sevasemten 10 mg (DRUG), Sevasemten 5 mg (DRUG), Sevasemten 12.5 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05291091?
This trial is sponsored by Edgewise Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05291091 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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