Trial · NCT05818137
A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)
NCT05818137, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2025-02-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020). Trials, record NCT05818137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05818137
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)
- NCT number
- NCT05818137
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 46 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Sotatercept
- First posted
- 2023-04-18
- Last updated
- 2026-06-10
- Results first posted
- 2025-02-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24 | Baseline and Week 24 | PVR was the resistance against blood flow from the pulmonary artery to the left atrium. PVR was measured in dyn\*sec/cm\^5 by right heart catheterization (RHC). RHC was performed during the screening period (baseline) and Week 24. Per protocol, the change in PVR from baseline at Week 24 was reported for the primary treatment period. |
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | Up to ~24 weeks | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who experienced an AE were reported for the primary treatment period. |
| Primary | Number of Participants Who Discontinued Study Intervention Due to AEs | Up to ~24 weeks | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who discontinued study treatment due to AEs were reported for the primary treatment period. |
| Secondary | Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24 | Baseline and Week 24 | The 6MWD was the distance walked in 6 minutes as a measure of functional capacity was measured during the screening period (baseline) and at Week 24. This was assessed using the 6-minute walk test (6MWT). Per protocol, the change from baseline in 6MWD at Week 24 was reported for the primary treatment period. |
| Secondary | Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24 | Baseline and Week 24 | The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Per protocol, the percentage of participants with improvement in WHO FC at Week 24 were presented for the primary treatment period. |
| Secondary | Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24 | Baseline and Week 24 | NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP was measured at Day 1 (baseline) and at Week 24. The change from baseline in NT-proBNP at Week 24 was reported for the primary treatment period. |
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 | Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24 | Baseline and Week 24 | All participants who received at least one dose of study intervention in the primary treatment period. | dynes*sec/cm^5 | MEDIAN |
| PRIMARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to ~24 weeks | All participants who received at least one dose of study intervention in the primary treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Study Intervention Due to AEs | Up to ~24 weeks | All participants who received at least one dose of study intervention in the primary treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24 | Baseline and Week 24 | All participants who received at least one dose of study intervention in the primary treatment period. | Meter | MEDIAN |
| SECONDARY | Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24 | Baseline and Week 24 | All participants who received at least one dose of study intervention in the primary treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24 | Baseline and Week 24 | All participants who received at least one dose of study intervention in primary treatment period. | pg/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24 | Sotatercept - Primary Treatment Period | 417.2 | Full Range 235.2 to 812.8 | dynes*sec/cm^5 | |
| Number of Participants Who Experienced an Adverse Event (AE) | Sotatercept - Primary Treatment Period | 43 | Participants | ||
| Number of Participants Who Discontinued Study Intervention Due to AEs | Sotatercept - Primary Treatment Period | 0 | Participants | ||
| Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24 | Sotatercept - Primary Treatment Period | 462.0 | Full Range 305.0 to 560.0 | Meter | |
| Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24 | Sotatercept - Primary Treatment Period | 19.6 | 95% Confidence Interval 9.4 to 33.9 | Percentage of participants | |
| Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24 | Sotatercept - Primary Treatment Period | 18.5 | Full Range 18.5 to 1471.0 | pg/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Treatment Period | STARTED | Sotatercept | 46 | |
| Primary Treatment Period | COMPLETED | Sotatercept | 46 | |
| Primary Treatment Period | NOT COMPLETED | Sotatercept | 0 | |
| Extension Treatment Period | STARTED | Sotatercept | 45 | |
| Extension Treatment Period | COMPLETED | Sotatercept | 0 | |
| Extension Treatment Period | NOT COMPLETED | Sotatercept | 45 |
Source ClinicalTrials.gov
Adverse events40
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 | Vertigo | Ear and labyrinth disorders | Sotatercept - Primary Treatment Period | 3 | 46 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Sotatercept - Extension Treatment Period | 0 | 45 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Sotatercept - Primary Treatment Period | 3 | 46 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Sotatercept - Extension Treatment Period | 0 | 45 | 0 |
| other | Malaise | General disorders | Sotatercept - Primary Treatment Period | 3 | 46 | 3 |
| other | Malaise | General disorders | Sotatercept - Extension Treatment Period | 0 | 45 | 0 |
| other | Pyrexia | General disorders | Sotatercept - Primary Treatment Period | 3 | 46 | 3 |
| other | Pyrexia | General disorders | Sotatercept - Extension Treatment Period | 0 | 45 | 0 |
| other | COVID-19 | Infections and infestations | Sotatercept - Primary Treatment Period | 3 | 46 | 3 |
| other | COVID-19 | Infections and infestations | Sotatercept - Extension Treatment Period | 0 | 45 | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sotatercept - Primary Treatment Period | 0 | 46 |
| Total, all-cause mortality | Sotatercept - Extension Treatment Period | 0 | 45 |
| Total, other adverse events | Sotatercept - Primary Treatment Period | 36 | 46 |
| Total, other adverse events | Sotatercept - Extension Treatment Period | 12 | 45 |
| Total, serious adverse events | Sotatercept - Primary Treatment Period | 6 | 46 |
| Total, serious adverse events | Sotatercept - Extension Treatment Period | 2 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41618947 | 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 - Primary Treatment Period vs Sotatercept - Extension Treatment Period: deaths from any cause | Trial comparisons |
| Sotatercept - Primary Treatment Period vs Sotatercept - Extension Treatment 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/NCT05818137
GET https://conductscience.org/api/trials/v1/NCT05818137/events?page=2