A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)

Description

Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. The goal of the study is to learn: * What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. * About the safety of sotatercept and if people tolerate it

Conditions

Pulmonary Arterial Hypertension

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Study Overview

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Study Details

Study overview

Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. The goal of the study is to learn: * What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. * About the safety of sotatercept and if people tolerate it

A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)

Condition
Pulmonary Arterial Hypertension
Intervention / Treatment

-

Contacts and Locations

Phoenix

Pulmonary Associates, PA ( Site 1903), Phoenix, Arizona, United States, 85032

Indianapolis

Indiana University Health Methodist Hospital ( Site 1905), Indianapolis, Indiana, United States, 46202

Louisville

Norton Pulmonary Specialists ( Site 1935), Louisville, Kentucky, United States, 40202

Albuquerque

University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916), Albuquerque, New Mexico, United States, 87131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
  • * Has symptomatic PAH classified as WHO Functional Class II or III
  • * Has a weight of \<35 kg
  • * Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
  • * Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
  • * Has uncontrolled systemic hypertension
  • * Has a history of pneumonectomy
  • * Has a history of known pericardial constriction
  • * Has a history of restrictive cardiomyopathy
  • * Has history of atrial septostomy (within 180 days prior to study start)
  • * Has personal or family history of long QT syndrome
  • * Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
  • * Has a cerebrovascular accident (within 3 months prior to study start)
  • * Has significant (\>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
  • * Has untreated more than mild obstructive sleep apnea
  • * Has known malignancy that is progressing or has required active treatment within the past 5 years
  • * Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
  • * Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2026-07-10