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NCT05291091 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)

A Phase 2 study of Becker Muscular Dystrophy, sponsored by Edgewise Therapeutics.

Active
Registry status
Phase 2
Development phase
244
Enrollment target
20
Study locations

NCT05291091: Active Phase 2 study of Becker Muscular Dystrophy, sponsored by Edgewise Therapeutics.

NCT05291091 is a Phase 2 study of Becker Muscular Dystrophy that is active but no longer recruiting, run by Edgewise Therapeutics. The registered enrollment target is 244 participants, below the 1,376-participant average among 12 other Becker Muscular Dystrophy trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05291091, a Phase 2 study of Becker Muscular Dystrophy, is active but no longer recruiting, sponsored by Edgewise Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
244 participants
Enrollment target
20
Study locations

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.

Primary Outcome

All participants

Conditions Studied

Becker Muscular Dystrophy

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

FieldValue
Enrollment Target 244 participants
Start Date 2022-11-10
Est. Completion 2026-09
Phase Phase 2
Edgewise Therapeutics

15 total trials

What the registry record for NCT05291091 still lists

NCT05291091 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 1,376-participant average among 12 other Becker Muscular Dystrophy trials with a reported enrollment target (82% lower).

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.

NCT05291091 names 20 study sites across 16 states, led by California, Arkansas, Colorado.

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.

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).

Who is sponsoring clinical trial NCT05291091?

This trial is sponsored by Edgewise Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Becker Muscular Dystrophy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05291091's enrollment target sits among peer trials

244 6th of 12 higher than 7 of 12 other Becker Muscular Dystrophy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Becker Muscular Dystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05291091, the US trial registry maintained by the National Library of Medicine. NCT05291091 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.