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Clinical Trials in India / NCT07600723
Recruiting Phase 4

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

NCT07600723 · tracked via the Priya Life Science India tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 4
Started
2026-10-08
Last updated
2026-10-22

Condition(s) studied

Pulmonary Arterial Hypertension

Investigational drug(s) / intervention(s)

Sotatercept →Background PAH Therapy

Sotatercept: Administered as SC injection

Background PAH Therapy: 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 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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 Exclusion Criteria: 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 * 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

Primary outcome measure(s)

  • Number of participants who experience an adverse event (AE) — 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 intervention due to an AE — 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 intervention due to an AE will be reported.

Trial sites (1)

FacilityCityRegionStatus
KLES Dr. Prabhakar Kore Hospital & M.R.C ( Site 0013) Belagavi Karnataka Recruiting

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Other trials for the same condition

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07600723 on ClinicalTrials.gov ↗ ← All trials in India