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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Pulmonary Arterial Hypertension

Treatments: Biological: Sotatercept; Biological: Background PAH Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06664801

U1111-1304-7985 (Other Identifier)

7962-024

jRCT2061240077 (Registry Identifier)

2024-512278-92 (Registry Identifier)

MK-7962-024 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Weight-based sotatercept dosing

Experimental group

Description:

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.

Treatment:

Biological: Background PAH Therapy

Biological: Sotatercept

Weight-banded sotatercept dosing

Experimental group

Description:

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.

Treatment:

Biological: Background PAH Therapy

Biological: Sotatercept