Hypertension, PulmonaryPhase 4NCT07899905
A Clinical Study of MK-7962 in Chinese Participants With Pulmonary Arterial Hypertension (MK-7962-022)
A Phase 4 study testing Sotatercept in people with Hypertension, Pulmonary, run by Merck Sharp & Dohme LLC.
Trial summary
Researchers are looking for ways to treat people with a type of high blood pressure in the lungs called pulmonary arterial hypertension (PAH). This study focuses on Chinese participants who are already taking stable, standard-of-care medications for their PAH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Sotatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 21 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a documented diagnosis of Pulmonary Arterial Hypertension (PAH, WHO Group 1), classified as WHO Functional Class (FC) II or III.
- Must be on stable doses of background PAH therapy for at least 90 days prior to screening.
- Screening evaluation must show a 6-Minute Walk Distance (6MWD) between 150 and 500 meters.
- Hemodynamic assessment via Right Heart Catheterization (RHC) must confirm a Pulmonary Vascular Resistance (PVR) of ≥5 Wood units.
Who cannot join
- Participants with Pulmonary Hypertension from WHO Groups 2, 3, 4, or 5 are excluded.
- Excludes specific PAH subtypes, including those associated with: portal hypertension, Schistosomiasis-associated PAH, pulmonary veno-occlusive disease, and HIV.
- Participants with significant left-sided heart disease (e.g., LVEF <45%) or certain cardiomyopathies are excluded.
- Participants with a history of certain bleeding risks or very low platelet counts (<50,000/mm³).
- Participants with any prior exposure to sotatercept or luspatercept are excluded.
About this study
Official title: An Open-Label, Single-Arm, Multi-Center, Post-Marketing Study to Evaluate the Efficacy and Safety of Sotatercept (MK-7962) Add-on to Background Therapy in Chinese Participants With Pulmonary Arterial Hypertension (PAH)
Researchers are looking for ways to treat people with a type of high blood pressure in the lungs called pulmonary arterial hypertension (PAH). This study focuses on Chinese participants who are already taking stable, standard-of-care medications for their PAH. Researchers want to know if adding the study treatment, sotatercept, to their current background treatment can help treat people with PAH.
Participants in this study will start a new treatment regimen where they will receive sotatercept as an add-on therapy, and researchers will monitor their health.
The main goals of this study are to learn if sotatercept is safe, if participants tolerate it well, and how effective it is at improving their exercise capacity and physical health when added to their ongoing PAH treatment.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Sotatercept
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptBiological
Also called ACE-011
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept | Experimental | Sotatercept will be administered subcutaneous (SC) starting at a dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks (Q3W) plus background Pulmonary Arterial Hypertension (PAH) therapy. Receives: Biological: Sotatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 24.
The 6MWD is a clinical test that measures the distance, in meters, that a participant can walk on a flat, hard surface in a period of 6 minutes. This test evaluates the participant's integrated response to exercise (functional capacity). An increase in the distance walked represents an improvement in functional exercise capacity. The change from baseline is calculated by subtracting the baseline distance from the Week 24 distance.
Measured: Baseline and Week 24
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 37 weeks.
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 21 weeks.
Secondary outcomes (3)
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from baseline in PVR at Week 24 will be presented.
Measured: Baseline and Week 24
Percentage of Participants with Improvement in World Health Organization (WHO) Functional Class (FC) at Week 24
The WHO FC is a 4-category scale (Class I, II, III, or IV) that assesses the severity of a participant's disease based on symptoms and physical limitations. A lower class indicates less severe disease. Improvement is defined as a decrease of at least one functional class from Baseline to Week 24. Maintenance of WHO FC II is defined as remaining in WHO FC II from Baseline to Week 24. The percentage of participants who demonstrate improvement or maintenance of WHO FC II at Week 24 will be reported.
Measured: Baseline and Week 24
Change from Baseline in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) at Week 24
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 24. The change from baseline in NT-proBNP at Week 24 will be presented.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion21 Mar 2028 (estimated)
- Study completion21 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899905
- Sponsor's protocol ID
- 7962-022
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multi-Center, Post-Marketing Study to Evaluate the Efficacy and Safety of Sotatercept (MK-7962) Add-on to Background Therapy in Chinese Participants With Pulmonary Arterial Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT07899905
- Acronym / sponsor ID
- 7962-022
- Conditions
- Hypertension, Pulmonary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 21 Mar 2028 (estimated)
- Study completion
- 21 Mar 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for ways to treat people with a type of high blood pressure in the lungs called pulmonary arterial hypertension (PAH). This study focuses on Chinese participants who are already taking stable, standard-of-care medications for their PAH. Researchers want to know if adding the study treatment, sotatercept, to their current background treatment can help treat people with PAH.
Participants in this study will start a new treatment regimen where they will receive sotatercept as an add-on therapy, and researchers will monitor their health.
The main goals of this study are to learn if sotatercept is safe, if participants tolerate it well, and how effective it is at improving their exercise capacity and physical health when added to their ongoing PAH treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sotatercept | Experimental | Biological: SotaterceptSotatercept will be administered subcutaneous (SC) starting at a dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks (Q3W) plus background Pulmonary Arterial Hypertension (PAH) therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have a documented diagnosis of Pulmonary Arterial Hypertension (PAH, WHO Group 1), classified as WHO Functional Class (FC) II or III.
- Must be on stable doses of background PAH therapy for at least 90 days prior to screening.
- Screening evaluation must show a 6-Minute Walk Distance (6MWD) between 150 and 500 meters.
- Hemodynamic assessment via Right Heart Catheterization (RHC) must confirm a Pulmonary Vascular Resistance (PVR) of ≥5 Wood units.
Key exclusion criteria (5 listed)
- Participants with Pulmonary Hypertension from WHO Groups 2, 3, 4, or 5 are excluded.
- Excludes specific PAH subtypes, including those associated with: portal hypertension, Schistosomiasis-associated PAH, pulmonary veno-occlusive disease, and HIV.
- Participants with significant left-sided heart disease (e.g., LVEF <45%) or certain cardiomyopathies are excluded.
- Participants with a history of certain bleeding risks or very low platelet counts (<50,000/mm³).
- Participants with any prior exposure to sotatercept or luspatercept are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotaterceptAlso: ACE-011subcutaneous injection | Biological | Sotatercept |
Primary outcome
Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 24.
Time frame: Baseline and Week 24
The 6MWD is a clinical test that measures the distance, in meters, that a participant can walk on a flat, hard surface in a period of 6 minutes. This test evaluates the participant's integrated response to exercise (functional capacity). An increase in the distance walked represents an improvement in functional exercise capacity. The change from baseline is calculated by subtracting the baseline distance from the Week 24 distance.
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 37 weeks.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 21 weeks.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
3 secondary outcomes
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24
Time frame: Baseline and Week 24
Percentage of Participants with Improvement in World Health Organization (WHO) Functional Class (FC) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) at Week 24
Time frame: Baseline and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sotatercept in people with Hypertension, Pulmonary, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 24. (time frame: Baseline and Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.