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

Merck Sharp & Dohme (MSD)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Background PAH Therapy; Biological: Sotatercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT06925750

7962-031

2024-518687-12 (Registry Identifier)

MK-7962-031 (Other Identifier)

U1111-1314-0614 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 prior exposure to luspatercept and/or is planning to begin treatment with luspatercept while enrolled in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Weight-banded sotatercept dosing

Experimental group

Description:

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.

Treatment:

Biological: Sotatercept

Drug: Background PAH Therapy