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

Phase 2Active Not RecruitingNCT06925750

Merck Sharp & Dohme LLC130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Pulmonary Arterial Hypertension

Interventions

Background PAH TherapyDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

Number of Participants Who Experience One or More Adverse Events (AEs)

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.

Time frame: Up to approximately 28 months

Number of Participants who Discontinue Study Intervention Due to an AE

Time frame: Up to approximately 24 months