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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 is a Phase 1 study that has completed, run by Edgewise Therapeutics. The registered enrollment target is 12 participants.

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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.

Interventions

  • DRUG Sevasemten

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2021-12-28
Est. Completion 2024-03-01
Phase Phase 1

Sponsor

Edgewise Therapeutics

15 total trials

What the Registry Record Tells You About NCT05160415

The ClinicalTrials.gov registry entry for NCT05160415 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edgewise Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Sevasemten is the first listed.

NCT05160415 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.