Trial · NCT02579239
Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD)
NCT02579239, Phase 1, Phase 2, Completed, aTyr Pharma, Inc.; results first posted 2023-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD). Trials, record NCT02579239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02579239
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD)
- NCT number
- NCT02579239
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- aTyr Pharma, Inc.
- Conditions
- Limb-Girdle Muscular Dystrophies, Facioscapulohumeral Muscular Dystrophy
- Interventions
- ATYR1940, Placebo
- First posted
- 2015-10-19
- Last updated
- 2023-10-19
- Other registries' IDs
- eudract:2015-001910-88
- Results first posted
- 2023-10-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to End of Study (up to Week 25) | TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. An AE was defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. An SAE was defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section. |
| Primary | Number of Participants With a Clinically Significant Electrocardiogram (ECG) Abnormality Leading to a TEAE | Up to End of Study (up to Week 25) | ECG parameters that were evaluated included heart rate, PR, and QR and QT intervals. A clinically significant ECG abnormality was based upon the Investigator's discretion. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Primary | Number of Participants With a Clinically Significant Pulmonary Function Event Resulting in a TEAE | Up to End of Study (up to Week 25) | Pulmonary evaluations included pulmonary function tests and pulse oximetry. Clinically significant changes were to be reported as adverse events. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Primary | Number of Participants With a Clinical Laboratory Abnormality Leading to an AE | Up to End of Study (up to Week 25) | Laboratory parameters included hematology (hematocrit, hemoglobin, red blood cell count, white blood cell count with differential \[neutrophils, lymphocytes, monocytes, eosinophils, basophils\], and platelet count); serum chemistries (blood urea nitrogen, creatinine, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, total protein, sodium, potassium, bicarbonate, calcium, chloride, magnesium, inorganic phosphate, creatine kinase, lactate dehydrogenase, erythrocyte sedimentation rate, C-reactive protein, troponin, myoglobin, insulin-like growth factor 1, and cholesterol \[(nonfasting\]); urinalysis (color, pH, specific gravity, protein, glucose, ketones, and blood). Clinically significant laboratory abnormalities were based upon Investigator's discretion. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Primary | Number of Participants With Vital Sign Abnormality Resulting in a TEAE | Up to End of Study (Up to Week 25) | The vital sign parameters that were evaluated included heart rate, systolic and diastolic blood pressure, and respiration rate as well as temperature. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Secondary | Percent Change From Baseline in Manual Muscle Testing (MMT) Score at Week 14 | Baseline, Week 14 | MMT (muscle strength) was graded on a scale from 0 (no contraction palpable) to 5 (normal strength). Decreased muscle strength was indicated by a decreased score. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to End of Study (up to Week 25) | Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Clinically Significant Electrocardiogram (ECG) Abnormality Leading to a TEAE | Up to End of Study (up to Week 25) | Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Clinically Significant Pulmonary Function Event Resulting in a TEAE | Up to End of Study (up to Week 25) | Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Clinical Laboratory Abnormality Leading to an AE | Up to End of Study (up to Week 25) | Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Sign Abnormality Resulting in a TEAE | Up to End of Study (Up to Week 25) | Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Manual Muscle Testing (MMT) Score at Week 14 | Baseline, Week 14 | Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Here, 'Overall Number of Participants Analyzed' (N) signifies number of participants evaluable for this outcome measure. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Group A - FSHD | TEAEs | 4 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Group B - LGMD2B and FSHD | TEAEs | 14 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Group A - FSHD | SAEs | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Group B - LGMD2B and FSHD | SAEs | 0 | Participants | |
| Number of Participants With a Clinically Significant Electrocardiogram (ECG) Abnormality Leading to a TEAE | Group A - FSHD | 0 | Participants | ||
| Number of Participants With a Clinically Significant Electrocardiogram (ECG) Abnormality Leading to a TEAE | Group B - LGMD2B and FSHD | 0 | Participants | ||
| Number of Participants With a Clinically Significant Pulmonary Function Event Resulting in a TEAE | Group A - FSHD | 0 | Participants | ||
| Number of Participants With a Clinically Significant Pulmonary Function Event Resulting in a TEAE | Group B - LGMD2B and FSHD | 0 | Participants | ||
| Number of Participants With a Clinical Laboratory Abnormality Leading to an AE | Group A - FSHD | 0 | Participants | ||
| Number of Participants With a Clinical Laboratory Abnormality Leading to an AE | Group B - LGMD2B and FSHD | 4 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A - FSHD | 4 | |
| Overall Study | STARTED | Group B - LGMD2B and FSHD | 14 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Group A - FSHD | 4 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Group B - LGMD2B and FSHD | 14 | |
| Overall Study | COMPLETED | Group A - FSHD | 4 | |
| Overall Study | COMPLETED | Group B - LGMD2B and FSHD | 14 | |
| Overall Study | NOT COMPLETED | Group A - FSHD | 0 | |
| Overall Study | NOT COMPLETED | Group B - LGMD2B and FSHD | 0 |
Source ClinicalTrials.gov
Adverse events108
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 | Headache | Nervous system disorders | Group A - FSHD | 2 | 4 | |
| other | Headache | Nervous system disorders | Group B - LGMD2B and FSHD | 7 | 14 | |
| other | Presyncope | Nervous system disorders | Group A - FSHD | 0 | 4 | |
| other | Presyncope | Nervous system disorders | Group B - LGMD2B and FSHD | 2 | 14 | |
| other | Asthenia | General disorders | Group A - FSHD | 1 | 4 | |
| other | Asthenia | General disorders | Group B - LGMD2B and FSHD | 2 | 14 | |
| other | Fatigue | General disorders | Group A - FSHD | 2 | 4 | |
| other | Fatigue | General disorders | Group B - LGMD2B and FSHD | 1 | 14 | |
| other | Pyrexia | General disorders | Group A - FSHD | 0 | 4 | |
| other | Pyrexia | General disorders | Group B - LGMD2B and FSHD | 2 | 14 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A - FSHD | ||
| Total, all-cause mortality | Group B - LGMD2B and FSHD | ||
| Total, other adverse events | Group A - FSHD | 4 | 4 |
| Total, other adverse events | Group B - LGMD2B and FSHD | 14 | 14 |
| Total, serious adverse events | Group A - FSHD | 0 | 4 |
| Total, serious adverse events | Group B - LGMD2B and FSHD | 0 | 14 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A - FSHD vs Group B - LGMD2B and FSHD: Number of Participants With Vital Sign Abnormality Resulting in a TEAE | Trial comparisons |
| Group A - FSHD vs Group B - LGMD2B and FSHD: Number of Participants With a Clinical Laboratory Abnormality Leading to an AE | Trial comparisons |
| Group A - FSHD vs Group B - LGMD2B and FSHD: Number of Participants With a Clinically Significant Pulmonary Function Event Resulting in a TEAE | Trial comparisons |
| Group A - FSHD vs Group B - LGMD2B and FSHD: Number of Participants With a Clinically Significant Electrocardiogram (ECG) Abnormality Leading to a TEAE | Trial comparisons |
| Group A - FSHD vs Group B - LGMD2B and FSHD: serious adverse events | Trial comparisons |
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/NCT02579239
GET https://conductscience.org/api/trials/v1/NCT02579239/events?page=2