Pulmonary Arterial HypertensionPhase 4NCT07600723
A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037)
A Phase 4 study testing Sotatercept and Background PAH Therapy in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 1 site in India.
Trial summary
Researchers are looking for other ways to treat people in India with pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH). In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Sotatercept and Background PAH Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 8 Oct 2026to 3 Apr 2028
- Phase
- Phase 4
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
- The main inclusion criteria include but are not limited to the following:
- Has documented historical diagnostic right heart catheterization (RHC), with the diagnosis of pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH), in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, and PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
- Has been on stable doses of PAH background therapies and diuretics (if applicable)
- Has symptomatic PAH classified as World Health Organization (WHO) Functional Classification (FC) II or III
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of Groups 2, 3, 4, or 5 PH
- Has a diagnosis of the following PAH (Group 1 PH) subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, PAH diagnosed with pulmonary veno occlusive disease (PVOD) or pulmonary capillary hemangiomatosis (PCH)
- Has uncontrolled systemic hypertension
- Has a history of full or partial pneumonectomy
- Has untreated more than mild obstructive sleep apnea
Show all 10Show fewer
- Has known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C
- Has a history of restrictive, constrictive, or congestive cardiomyopathy
- Has significant mitral regurgitation or aortic regurgitation valvular disease, mitral stenosis, and more than mild aortic valve stenosis
- Has known malignancy that is progressing or has required active treatment within the past 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
KLES Dr. Prabhakar Kore Hospital & M.R.C ( Site 0013)
Belagavi, Karnataka, 590010
Study Coordinator, 08312473777
About this study
Official title: A Phase 4, Prospective, Open-label, Single-Arm Study to Evaluate the Safety of Sotatercept in Adults With Pulmonary Arterial Hypertension (PAH) in India
Researchers are looking for other ways to treat people in India with pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH). In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. This causes high blood pressure in the lungs and can overwork the heart. PAH can make it hard to breathe and be active.
Researchers want to learn if sotatercept, the study medicine, can be given with standard treatment to help treat PAH. The standard treatment (the usual treatment) for PAH includes one or multiple medicines. However, these may not fully work or treat the symptoms of PAH in some people.
The goal of this study is to learn about the safety and tolerability of sotatercept when it is given with standard treatment to people in India.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Sotatercept, Background PAH Therapy
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptBiological
Also called MK-7962, ACE-011
Administered as SC injection
Background PAH TherapyDrug
Background PAH therapy refers to approved PAH-specific medications and may consist of a single, double, or triple combination of therapy with Endothelin Receptor Antagonists (ERAs), Phosphodiesterase Type 5 Inhibitors (PDE5), soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept | Experimental | Participants receive a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy. Receives: Biological: Sotatercept; Drug: Background PAH Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 intervention 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 intervention due to an AE will be reported.
Measured: Up to approximately 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start8 Oct 2026
- Primary completion3 Apr 2028 (estimated)
- Study completion3 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- 30 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
- NCT07600723
- Sponsor's protocol ID
- 7962-037
- Other IDs
- MK-7962-037
- Status last verified
- Oct 2026
- First submitted
- 15 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf