Sotatercept for Pulmonary Arterial Hypertension
(LIGHTRAY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called sotatercept for individuals with pulmonary arterial hypertension (PAH). PAH causes the blood vessels in the lungs to thicken and narrow, hindering blood flow. The study will compare two dosing methods of sotatercept to determine which is more effective and safer. Individuals with PAH who experience symptoms like reduced exercise capacity or shortness of breath may be suitable for this trial. Participants will continue their current PAH treatments while receiving sotatercept injections every three weeks. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that sotatercept is generally well-tolerated by people with pulmonary arterial hypertension (PAH). In earlier studies, adding sotatercept to other PAH treatments improved exercise capacity and reduced the likelihood of symptom worsening. Long-term studies indicate that the benefits of sotatercept outweigh the downsides.
Safety data from past research shows that researchers have carefully monitored sotatercept, and a safety committee has reviewed the results to ensure its safety. While no treatment is completely free of side effects, testing suggests that sotatercept is safe for most people when added to existing PAH treatments. Prospective participants should always consult a doctor about what to expect when considering joining a trial.12345Why are researchers excited about this trial's treatment for PAH?
Researchers are excited about sotatercept for pulmonary arterial hypertension (PAH) because it introduces a novel approach by targeting the transforming growth factor-beta (TGF-β) superfamily, which is different from the standard therapies like endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclins. Most current treatments focus on relaxing blood vessels and improving blood flow, but sotatercept works by potentially reducing the excessive proliferation of blood vessel cells, addressing a root cause of the disease. Additionally, sotatercept is administered via subcutaneous injection every three weeks, which could offer a more convenient dosing schedule compared to some existing treatments. These unique features have sparked interest in its potential to offer improved outcomes for PAH patients.
What evidence suggests that sotatercept might be an effective treatment for pulmonary arterial hypertension?
Studies have shown that sotatercept can help treat pulmonary arterial hypertension (PAH) by improving exercise capacity and reducing the likelihood of symptom worsening. In this trial, participants will receive sotatercept using one of two dosing methods: weight-based or weight-banded, alongside their regular PAH medications. Earlier trials demonstrated that patients who took sotatercept with their regular PAH medications experienced overall improvement. The drug aids the blood vessels in the lungs, which can become thick and narrow in PAH, allowing blood to flow more easily. Early and ongoing research indicates that sotatercept offers a good balance of benefits and risks for people with PAH.12345
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for people with Pulmonary Arterial Hypertension (PAH) who have had a specific heart catheterization test. It's open to those with various PAH types, including idiopathic, heritable, drug-induced or associated with other conditions. Participants should be experiencing symptoms and classified as WHO Functional Class II or III.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sotatercept via subcutaneous injection every 3 weeks using either a weight-based or weight-banded method during a 24-week treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sotatercept
Sotatercept is already approved in European Union, United States for the following indications:
- Pulmonary arterial hypertension (PAH, WHO Group 1)
- Pulmonary arterial hypertension (PAH, WHO Group 1)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University