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

NCT07600723 | Not Yet Recruiting Phase 4

• 2 other identifiers: 7962-037MK-7962-037
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately 21 weeks

Study Arms (1)

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.

Biological: Sotatercept; Drug: Background PAH Therapy

Interventions

Sotatercept BIOLOGICAL

Administered as SC injection

Also known as: MK-7962, ACE-011

Sotatercept

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

Sotatercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 24, 2026
• Primary Completion (Estimated): April 3, 2028
• Study Completion (Estimated): April 3, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share