Print

Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Weight-based sotatercept dosing 		Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
  • Biological: Sotatercept
    SC administered every 3 weeks.
    Other names:
    • MK-7962
  • Biological: Background PAH Therapy
    Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists
Experimental
Weight-banded sotatercept dosing 		Participants will receive sotatercept via SC injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
  • Biological: Sotatercept
    SC administered every 3 weeks.
    Other names:
    • MK-7962
  • Biological: Background PAH Therapy
    Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists

Recruiting Locations

University of Kansas Medical Center ( Site 1928)
Kansas City, Kansas 66160
Contact:
Study Coordinator
913-588-6045

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.