Trial Outcomes & Findings for A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) (NCT NCT05818137)
NCT ID: NCT05818137
Last Updated: 2026-01-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
46 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2026-01-14
Participant Flow
All allocated participants.
Participant milestones
| Measure |
Sotatercept
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants received sotatercept at the same dose and schedule in the extension treatment period Week 24 to Week 42.
|
|---|---|
|
Primary Treatment Period
STARTED
|
46
|
|
Primary Treatment Period
COMPLETED
|
46
|
|
Primary Treatment Period
NOT COMPLETED
|
0
|
|
Extension Treatment Period
STARTED
|
45
|
|
Extension Treatment Period
COMPLETED
|
0
|
|
Extension Treatment Period
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Sotatercept
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants received sotatercept at the same dose and schedule in the extension treatment period Week 24 to Week 42.
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|---|---|
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Extension Treatment Period
Withdrawal by Subject
|
1
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|
Extension Treatment Period
Ongoing participants
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44
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Baseline Characteristics
A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)
Baseline characteristics by cohort
| Measure |
Sotatercept
n=46 Participants
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants received sotatercept at the same dose and schedule in the extension treatment period Week 24 to Week 42.
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|---|---|
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Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 16.3 • n=14 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
46 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Pulmonary Vascular Resistance (PVR) at Baseline
≤800 dyn*sec/cm^5
|
43 Participants
n=14 Participants
|
|
Pulmonary Vascular Resistance (PVR) at Baseline
>800 dyn*sec/cm^5
|
3 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: All participants who received at least one dose of study intervention in the primary treatment period.
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.
Outcome measures
| Measure |
Sotatercept - Primary Treatment Period
n=46 Participants
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks.
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|---|---|
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Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24
|
417.2 dynes*sec/cm^5
Interval 235.2 to 812.8
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PRIMARY outcome
Timeframe: Up to ~24 weeksPopulation: All participants who received at least one dose of study intervention in the primary treatment period.
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.
Outcome measures
| Measure |
Sotatercept - Primary Treatment Period
n=46 Participants
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks.
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|---|---|
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Number of Participants Who Experienced an Adverse Event (AE)
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43 Participants
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PRIMARY outcome
Timeframe: Up to ~24 weeksPopulation: All participants who received at least one dose of study intervention in the primary treatment period.
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.
Outcome measures
| Measure |
Sotatercept - Primary Treatment Period
n=46 Participants
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks.
|
|---|---|
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Number of Participants Who Discontinued Study Intervention Due to AEs
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0 Participants
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SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants who received at least one dose of study intervention in the primary treatment period.
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.
Outcome measures
| Measure |
Sotatercept - Primary Treatment Period
n=46 Participants
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks.
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|---|---|
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Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24
|
462.0 Meter
Interval 305.0 to 560.0
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SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants who received at least one dose of study intervention in the primary treatment period.
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.
Outcome measures
| Measure |
Sotatercept - Primary Treatment Period
n=46 Participants
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks.
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|---|---|
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Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24
|
19.6 Percentage of participants
Interval 9.4 to 33.9
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SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants who received at least one dose of study intervention in primary treatment period.
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.
Outcome measures
| Measure |
Sotatercept - Primary Treatment Period
n=46 Participants
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks.
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|---|---|
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Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24
|
18.5 pg/mL
Interval 18.5 to 1471.0
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Adverse Events
Sotatercept - Primary Treatment Period
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Sotatercept - Extension Treatment Period
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sotatercept - Primary Treatment Period
n=46 participants at risk
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks.
|
Sotatercept - Extension Treatment Period
n=45 participants at risk
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks from Week 24 to Week 42.
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|---|---|---|
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Gastrointestinal disorders
Large intestine polyp
|
2.2%
1/46 • Number of events 1 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Infections and infestations
Bacteraemia
|
2.2%
1/46 • Number of events 1 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Infections and infestations
Catheter site infection
|
2.2%
1/46 • Number of events 2 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/46 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
2.2%
1/45 • Number of events 1 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.2%
1/46 • Number of events 1 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Nervous system disorders
Loss of consciousness
|
2.2%
1/46 • Number of events 1 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Product Issues
Device physical property issue
|
2.2%
1/46 • Number of events 1 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/46 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
2.2%
1/45 • Number of events 1 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
Other adverse events
| Measure |
Sotatercept - Primary Treatment Period
n=46 participants at risk
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks.
|
Sotatercept - Extension Treatment Period
n=45 participants at risk
Participants on background PAH therapy received sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks from Week 24 to Week 42.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
6.5%
3/46 • Number of events 3 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Ear and labyrinth disorders
Vertigo
|
6.5%
3/46 • Number of events 3 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
3/46 • Number of events 3 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
General disorders
Malaise
|
6.5%
3/46 • Number of events 3 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
General disorders
Pyrexia
|
6.5%
3/46 • Number of events 3 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
30.4%
14/46 • Number of events 15 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
15.6%
7/45 • Number of events 8 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Investigations
Haemoglobin increased
|
17.4%
8/46 • Number of events 8 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
6.7%
3/45 • Number of events 3 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
3/46 • Number of events 3 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Nervous system disorders
Headache
|
21.7%
10/46 • Number of events 10 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
2.2%
1/45 • Number of events 1 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.4%
8/46 • Number of events 12 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
11.1%
5/45 • Number of events 5 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
3/46 • Number of events 3 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
6.5%
3/46 • Number of events 3 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
0.00%
0/45 • Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42)
All-cause mortality was reported on all allocated participants. Serious and nonserious AEs were reported in all participants who received a dose of study intervention.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER