Trial · NCT03738150
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension
NCT03738150, Phase 2, Completed, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA; results first posted 2023-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension. Trials, record NCT03738150. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03738150
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension
- NCT number
- NCT03738150
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Sotatercept, SOC
- First posted
- 2018-11-13
- Last updated
- 2024-08-27
- Results first posted
- 2023-02-10
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Peak Oxygen Uptake (VO2 Max) at 24 Weeks | Baseline and 24 weeks | Each participant's VO2 max was measured by an invasive cardiopulmonary exercise test (iCPET) at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular Stroke Volume (RV SV) at 24 Weeks | Baseline and 24 weeks | Each participant's RV SV was measured by cardiac MRI at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular End-Systolic Volume (RV ESV) at 24 Weeks | Baseline and 24 weeks | Each participant's RV ESV was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular End-Diastolic Volume (RV EDV) at 24 Weeks | Baseline and 24 weeks | Each participant's RV EDV was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Percent Change From Baseline in Right Ventricular Ejection Fraction (RV EF) at 24 Weeks | Baseline and 24 Weeks | Each participant's RV EF was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular Stroke Volume Index (RV SVI) at 24 Weeks | Baseline and 24 weeks | Each participant's RV SVI was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular (RV) Mass at 24 Weeks | Baseline and 24 weeks | Each participant's RV mass was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Ventilatory Efficiency (VE/VCO2 Slope) at 24 Weeks | Baseline and 24 weeks | VE/VCO2 slope refers to the slope of the regression line of Minute Ventilation (VE) in liters/minute in the Y-axis and corresponding carbon dioxide production per minute (VCO2) in liters/minute in the X-axis plotted with multiple measurements taken during exercise. Each participant's VE/VCO2 slope at peak exercise was measured by an iCPET at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Cardiac Index at 24 Weeks | Baseline and 24 weeks | Each participant's cardiac index at peak exercise was measured by iCPET at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Mean Pulmonary Arterial Pressure at 24 Weeks | Baseline and 24 weeks | Each participant's pulmonary arterial pressure at peak exercise was measured by iCPET at baseline and at 24 weeks. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Peak Oxygen Uptake (VO2 Max) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at End Of Treatment (EOT), with no major protocol deviations. | mL/min/kg | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular Stroke Volume (RV SV) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | mL | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular End-Systolic Volume (RV ESV) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | mL | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular End-Diastolic Volume (RV EDV) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | mL | MEAN |
| SECONDARY | Percent Change From Baseline in Right Ventricular Ejection Fraction (RV EF) at 24 Weeks | Baseline and 24 Weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | Percent change | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular Stroke Volume Index (RV SVI) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | mL/m^2 | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular (RV) Mass at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | grams | MEAN |
| SECONDARY | Change From Baseline in Ventilatory Efficiency (VE/VCO2 Slope) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | Unitless | MEAN |
| SECONDARY | Change From Baseline in Cardiac Index at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations; and who had data for Change from Baseline in Cardiac Index at 24 Weeks. | Liter/min/m^2 | MEAN |
| SECONDARY | Change From Baseline in Mean Pulmonary Arterial Pressure at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations; and who had data for Change from Baseline in Mean Pulmonary Arterial Pressure at 24 Weeks. | mmHg | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Peak Oxygen Uptake (VO2 Max) at 24 Weeks | Sotatercept | 1.28 | Standard Deviation 2.628 | mL/min/kg | |
| Change From Baseline in Right Ventricular Stroke Volume (RV SV) at 24 Weeks | Sotatercept | -27.306 | Standard Deviation 26.5786 | mL | |
| Change From Baseline in Right Ventricular End-Systolic Volume (RV ESV) at 24 Weeks | Sotatercept | -39.151 | Standard Deviation 22.5544 | mL | |
| Change From Baseline in Right Ventricular End-Diastolic Volume (RV EDV) at 24 Weeks | Sotatercept | -66.459 | Standard Deviation 37.3311 | mL | |
| Percent Change From Baseline in Right Ventricular Ejection Fraction (RV EF) at 24 Weeks | Sotatercept | -1.3 | Standard Deviation 8.48 | Percent change | |
| Change From Baseline in Right Ventricular Stroke Volume Index (RV SVI) at 24 Weeks | Sotatercept | -15.073 | Standard Deviation 14.8219 | mL/m^2 | |
| Change From Baseline in Right Ventricular (RV) Mass at 24 Weeks | Sotatercept | -6.240 | Standard Deviation 13.3558 | grams | |
| Change From Baseline in Ventilatory Efficiency (VE/VCO2 Slope) at 24 Weeks | Sotatercept | -8.87 | Standard Deviation 12.298 | Unitless | |
| Change From Baseline in Cardiac Index at 24 Weeks | Sotatercept | 0.411 | Standard Deviation 1.1944 | Liter/min/m^2 | |
| Change From Baseline in Mean Pulmonary Arterial Pressure at 24 Weeks | Sotatercept | -14.9 | Standard Deviation 13.22 | mmHg |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Base Study | STARTED | Sotatercept | 21 | |
| Base Study | COMPLETED | Sotatercept | 20 | |
| Base Study | NOT COMPLETED | Sotatercept | 1 | |
| Extension Study | STARTED | Sotatercept | 20 | |
| Extension Study | COMPLETED | Sotatercept | 19 | |
| Extension Study | NOT COMPLETED | Sotatercept | 1 |
Source ClinicalTrials.gov
Adverse events66
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 | Polycythaemia | Blood and lymphatic system disorders | Sotatercept Treatment Period | 3 | 21 | 9 |
| other | Polycythaemia | Blood and lymphatic system disorders | Sotatercept Extension Period | 5 | 20 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Sotatercept Treatment Period | 1 | 21 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Sotatercept Extension Period | 2 | 20 | 2 |
| other | Nausea | Gastrointestinal disorders | Sotatercept Treatment Period | 2 | 21 | 2 |
| other | Nausea | Gastrointestinal disorders | Sotatercept Extension Period | 4 | 20 | 4 |
| other | Vomiting | Gastrointestinal disorders | Sotatercept Treatment Period | 2 | 21 | 2 |
| other | Vomiting | Gastrointestinal disorders | Sotatercept Extension Period | 2 | 20 | 2 |
| other | Chest pain | General disorders | Sotatercept Treatment Period | 0 | 21 | 0 |
| other | Chest pain | General disorders | Sotatercept Extension Period | 4 | 20 | 4 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sotatercept Treatment Period | 0 | 21 |
| Total, all-cause mortality | Sotatercept Extension Period | 0 | 20 |
| Total, other adverse events | Sotatercept Treatment Period | 14 | 21 |
| Total, other adverse events | Sotatercept Extension Period | 18 | 20 |
| Total, serious adverse events | Sotatercept Treatment Period | 4 | 21 |
| Total, serious adverse events | Sotatercept Extension Period | 2 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38572639 | RESULT |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sotatercept Treatment Period vs Sotatercept Extension Period: deaths from any cause | Trial comparisons |
| Sotatercept Treatment Period vs Sotatercept Extension Period: 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/NCT03738150
GET https://conductscience.org/api/trials/v1/NCT03738150/registered?page=2