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

Condition(s) studied

Investigational drug(s) / intervention(s)

Sotatercept: SC injection administered every 3 weeks

Background PAH Therapy: 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

Study 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.

Eligibility

Primary outcome measure(s)

• 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 sites (73)

+ 33 more sites — see the full list on the official registry below.