A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07600723
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sotatercept — BIOLOGICAL
    Administered as SC injection
  • Background PAH Therapy — DRUG
    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 Details

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.

Key Dates

First listed
May 22, 2026
Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Apr 3, 2028
Completion
Apr 3, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sotatercept
    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.

Primary Outcome Measure

Number of participants who experience an adverse event (AE) [ Time Frame: Up to approximately 37 weeks ]

Central Contacts

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