Trial · NCT05160415
A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy
NCT05160415, Phase 1, Completed, Edgewise Therapeutics, Inc.; results first posted 2025-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy. Trials, record NCT05160415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05160415
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy
- NCT number
- NCT05160415
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- Edgewise Therapeutics, Inc.
- Conditions
- Becker Muscular Dystrophy
- Interventions
- Sevasemten
- First posted
- 2021-12-16
- Last updated
- 2025-06-24
- Results first posted
- 2025-06-24
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Treated With Sevasemten Experiencing AEs | From first dose of study drug to 25 months | 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 experiencing at least one AE after first dose of study drug up to 25 months. |
| Primary | Frequency of AEs in Those Treated With Sevasemten | From first dose of study drug to 25 months | 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 endpoint is the cumulative total number of AEs occurring after first dose of study drug up to 25 months among participants who received at least one dose of study drug. |
| Primary | Number of Participants Treated With Sevasemten With AEs by Maximum Severity | From first dose of study drug to 25 months | 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 severity of an AE is graded, according to the study protocol definitions of AE severity/intensity, as "mild", "moderate" or "severe". Participants who reported multiple AEs are counted only once at the highest severity reported. |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Abnormal Clinical Chemistry Test Results | From first dose of study drug to 25 months | Treatment-emergent defined as any event that occurs after the start of study drug or was present at baseline and worsened after taking study drug. The numerator of the percentage is the number of participants experiencing at least one treatment-emergent abnormal clinical chemistry test result after first dose of study drug up to 25 months. |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Abnormal Hematology Test Results | From first dose of study drug to 25 months | Treatment-emergent defined as any event that occurs after the start of study drug or was present at baseline and worsened after taking study drug. The numerator of the percentage is the number of participants experiencing at least one treatment-emergent abnormal hematology test result after first dose of study drug up to 25 months. |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Abnormal Coagulation Test Results | From first dose of study drug to 25 months | Treatment-emergent defined as any event that occurs after the start of study drug or was present at baseline and worsened after taking study drug. The numerator of the percentage is the number of participants experiencing at least one treatment-emergent abnormal coagulation test result after first dose of study drug up to 25 months. |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Abnormal Urinalysis Test Results | From first dose of study drug to 25 months | Treatment-emergent defined as any event that occurs after the start of study drug or was present at baseline and worsened after taking study drug. The numerator of the percentage is the number of participants experiencing at least one treatment-emergent abnormal urinalysis test result after first dose of study drug up to 25 months. |
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Chemistry | From first dose of study drug to 24 months | Refer to Protocol for list of clinical chemistry tests that were performed. Clinically significant changes in clinical chemistry are defined as adverse events related to clinical chemistry tests or investigator identified results reported from first dose of study drug up to 24 months. Only clinically significant changes were counted. |
| Secondary | Number of Participants With Clinically Significant Changes in Hematology | From first dose of study drug to 24 months | Refer to Protocol for list of hematology tests that were performed. Clinically significant changes in hematology are defined as adverse events related to hematology tests or investigator identified results reported from first dose of study drug up to 24 months. Only clinically significant changes were counted. |
| Secondary | Number of Participants With Clinically Significant Changes in Coagulation | From first dose of study drug to 24 months | Refer to Protocol for list of coagulation tests that were performed. Clinically significant changes in coagulation are defined as adverse events related to coagulation tests or investigator identified results reported from first dose of study drug up to 24 months. Only clinically significant changes were counted. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Treated With Sevasemten Experiencing AEs | From first dose of study drug to 25 months | Participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Frequency of AEs in Those Treated With Sevasemten | From first dose of study drug to 25 months | Participants who received at least one dose of study drug. | Count of Events | NUMBER |
| PRIMARY | Number of Participants Treated With Sevasemten With AEs by Maximum Severity | From first dose of study drug to 25 months | Participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Experiencing Treatment-Emergent Abnormal Clinical Chemistry Test Results | From first dose of study drug to 25 months | Participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Treatment-Emergent Abnormal Hematology Test Results | From first dose of study drug to 25 months | Participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Treatment-Emergent Abnormal Coagulation Test Results | From first dose of study drug to 25 months | Participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Treatment-Emergent Abnormal Urinalysis Test Results | From first dose of study drug to 25 months | Participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Changes in Clinical Chemistry | From first dose of study drug to 24 months | Participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Hematology | From first dose of study drug to 24 months | Participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Coagulation | From first dose of study drug to 24 months | Participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Treated With Sevasemten Experiencing AEs | Treatment | 100 | percentage of participants | ||
| Frequency of AEs in Those Treated With Sevasemten | Treatment | 95 | Count of Events | ||
| Number of Participants Treated With Sevasemten With AEs by Maximum Severity | Treatment | Mild | 10 | Participants | |
| Number of Participants Treated With Sevasemten With AEs by Maximum Severity | Treatment | Moderate | 2 | Participants | |
| Number of Participants Treated With Sevasemten With AEs by Maximum Severity | Treatment | Severe | 0 | Participants | |
| Percentage of Participants Experiencing Treatment-Emergent Abnormal Clinical Chemistry Test Results | Treatment | 0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Abnormal Hematology Test Results | Treatment | 0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Abnormal Coagulation Test Results | Treatment | 0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Abnormal Urinalysis Test Results | Treatment | 0 | percentage of participants | ||
| Number of Participants With Clinically Significant Changes in Clinical Chemistry | Treatment | 0 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 12 | |
| Overall Study | COMPLETED | Treatment | 9 | |
| Overall Study | NOT COMPLETED | Treatment | 3 |
Source ClinicalTrials.gov
Adverse events43
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Treatment | 5 | 12 | |
| other | Influenza | Infections and infestations | Treatment | 3 | 12 | |
| other | Nasopharyngitis | Infections and infestations | Treatment | 3 | 12 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Treatment | 3 | 12 | |
| other | Sinusitis | Infections and infestations | Treatment | 2 | 12 | |
| other | Gastroenteritis viral | Infections and infestations | Treatment | 1 | 12 | |
| other | Herpes zoster | Infections and infestations | Treatment | 1 | 12 | |
| other | Pharyngitis streptococcal | Infections and infestations | Treatment | 1 | 12 | |
| other | Fall | Injury, poisoning and procedural complications | Treatment | 4 | 12 | |
| other | Procedural pain | Injury, poisoning and procedural complications | Treatment | 3 | 12 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 0 | 12 |
| Total, other adverse events | Treatment | 12 | 12 |
| Total, serious adverse events | Treatment | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05160415
GET https://conductscience.org/api/trials/v1/NCT05160415/registered?page=2