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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sotatercept

Biological

SC injection administered every 3 weeks

Other names: MK-7962, ACE-011

Background PAH Therapy

Drug

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

Primary outcomes

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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

Acronym: LIGHTRAY EXT

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Apr 13, 2025
Registry last updated: Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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