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Completed

NCT Number: NCT06664801

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)

Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs.

The goal of the study is to learn:

* What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. * About the safety of sotatercept and if people tolerate it

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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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
  • Has symptomatic PAH classified as WHO Functional Class II or III

Exclusion criteria

  • Has a weight of <35 kg
  • Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
  • Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
  • Has uncontrolled systemic hypertension
  • Has a history of pneumonectomy
  • Has a history of known pericardial constriction
  • Has a history of restrictive cardiomyopathy
  • Has history of atrial septostomy (within 180 days prior to study start)
  • Has personal or family history of long QT syndrome
  • Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
  • Has a cerebrovascular accident (within 3 months prior to study start)
  • Has significant (>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
  • Has untreated more than mild obstructive sleep apnea
  • Has known malignancy that is progressing or has required active treatment within the past 5 years
  • Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
  • Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device

Treatment and study plan

Sotatercept

Biological

SC administered every 3 weeks.

Other names: MK-7962

Background PAH Therapy

Biological

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

  1. Steady-State Average Serum Concentrations of Sotatercept (Cavg)

    Time frame: Predose and at designated time points post-dose (up to 24 weeks)

    Steady-state Cavg of sotatercept will be reported.

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

    Time frame: Up to 37 weeks

    An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.

  3. Number of Participants who Discontinue Study Treatment due to an Adverse Event

    Time frame: Up to 21 weeks

    An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.

Secondary outcomes

  1. Initial Dose Average Serum Concentrations of Sotatercept (Cavg)

    Time frame: Predose and at designated time points post-dose (up to 3 weeks)

    Initial dose Cavg of sotatercept will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

Acronym: LIGHTRAY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
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.

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