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NCT05160415 · ClinicalTrials.gov registry record · Phase 1
A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy
A Phase 1 study, sponsored by Edgewise Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT05160415: Completed Phase 1 study, sponsored by Edgewise Therapeutics.
NCT05160415 is a Phase 1 study that has completed, run by Edgewise Therapeutics. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05160415, a Phase 1 study, has completed, sponsored by Edgewise Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The ARCH study was an open-label, single-center, Phase 1b study of sevasemtem (EDG-5506) to assess the safety and pharmacokinetics (PK) of sevasemten in adults with Becker muscular dystrophy (BMD). Sevasemten is an investigational product intended to protect and improve function of dystrophic muscle fibers.
Primary Outcome
An AE is any untoward medical occurrence in a patient administered a medicinal product. The AE does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The numerator of the percentage is the number of participants experiencin
Interventions
- DRUG Sevasemten
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-12-28 |
| Est. Completion | 2024-03-01 |
| Phase | Phase 1 |
What the finished NCT05160415 record still lists
NCT05160415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Sevasemten is the first listed.
NCT05160415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05160415 about?
NCT05160415 is a clinical study titled "A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy". The ARCH study was an open-label, single-center, Phase 1b study of sevasemtem (EDG-5506) to assess the safety and pharmacokinetics (PK) of sevasemten in adults with Becker muscular dystrophy (BMD). Sevasemten is an investigational product intended to protect and improve function of dystrophic muscl...
What is the current status of trial NCT05160415?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-12-28. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT05160415?
The interventions under investigation include: Sevasemten (DRUG).
Who is sponsoring clinical trial NCT05160415?
This trial is sponsored by Edgewise Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05160415's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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