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

Launched by MERCK SHARP & DOHME LLC · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called sotatercept for people with Pulmonary Arterial Hypertension (PAH), a condition where the blood vessels in the lungs become narrow, making it difficult for blood to flow. The researchers want to find out how different doses of sotatercept work in the body and whether a new way of giving the medication, based on weight bands rather than exact weight, is effective. They are also interested in learning about the safety of sotatercept and how well patients tolerate it.

To participate in the trial, you need to have a confirmed diagnosis of PAH and experience symptoms classified as Class II or III, meaning you may have some limitations in physical activity. However, there are specific eligibility criteria, such as being at least 35 kg in weight and not having certain other health conditions. If you join the study, you will receive sotatercept and be monitored closely for any side effects or changes in your condition. This trial is currently recruiting participants of all genders aged 65 to 74, so if you or someone you know might be interested, it could be a chance to contribute to important research in PAH treatment.

Gender

ALL

Eligibility criteria

• 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