A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)

Phase 2

Recruiting

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Biological: Sotatercept; Drug: Background PAH Therapy

• Registration Number: NCT06925750
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH.

A past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. One of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight.

This is an extension study, which means people who took part in MK-7962-024 (LIGHTRAY) may be able to join this study. In this extension study, people will get weight-banded doses of sotatercept. The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Study First Posted: 2025-04-13
• Study Start: 2025-05-12
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-19
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

• Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION)
• Has not started treatment with commercially available sotatercept

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

- Has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weight-banded sotatercept dosing	Sotatercept	Participants will receive sotatercept via subcutaneous (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 and will continue treatment for up to 24 months. All eligible participants will receive weight-banded dosing at the dosing level (initial or maintenance) at which they finished MK-7962-024 (LIGHTRAY). Participants will continue to take their background PAH therapy during the study.
Weight-banded sotatercept dosing	Background PAH Therapy	Participants will receive sotatercept via subcutaneous (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 and will continue treatment for up to 24 months. All eligible participants will receive weight-banded dosing at the dosing level (initial or maintenance) at which they finished MK-7962-024 (LIGHTRAY). Participants will continue to take their background PAH therapy during the study.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience One or More Adverse Events (AEs)	Up to approximately 28 months	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.
Number of Participants who Discontinue Study Intervention Due to an AE	Up to approximately 24 months	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.

Trial Locations

Locations (73)

University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930); 🇺🇸 Aurora, Colorado, United States

University of Kansas Medical Center ( Site 1928); 🇺🇸 Kansas City, Kansas, United States

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

Centro Medico Capital ( Site 0002); 🇦🇷 La Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006); 🇦🇷 Mar del Plata, Buenos Aires, Argentina

Instituto Medico Rio Cuarto ( Site 0010); 🇦🇷 Río Cuarto, Córdoba Province, Argentina

Instituto de Cardiologia Juana F. Cabral ( Site 0008); 🇦🇷 Corrientes, Argentina

Hospital Provincial Jose Maria Cullen ( Site 0005); 🇦🇷 Santa Fe, Argentina

Royal Prince Alfred Hospital ( Site 0103); 🇦🇺 Camperdown, New South Wales, Australia

Westmead Hospital ( Site 0100); 🇦🇺 Westmead, New South Wales, Australia

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