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NCT Number: NCT07218029

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.

Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.

This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.

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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 3

Primary location

Instituto de Investigaciones Clinicas Quilmes ( Site 1903), Quilmes, Buenos Aires, Argentina

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About this study

LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.

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 their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
  • Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
  • Must have the ability to understand and provide documented informed consent

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Did not participate in a sotatercept PAH parent study
  • Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
  • Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
  • Is a female who is pregnant or breastfeeding
  • Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
  • Is currently enrolled in another investigational product study other than a sotatercept study
  • Is incapacitated

Treatment and study plan

Sotatercept

Biological

Sotatercept SC injection every 3 weeks

Other names: MK-7962, ACE-011, ActRIIA-IgG1Fc, WINREVAIR®

Primary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 90 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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 86 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 treatment due to an AE will be reported.

  3. Number of Participants with Detectable Anti-Drug Antibodies (ADAs)

    Time frame: Up to approximately 88 months

    ADAs will be detected in serum. The number of participants with detectable ADAs will be reported.

  4. Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin

    Time frame: Up to approximately 88 months

    Blood samples will be collected to determine the concentration of platelets and hemoglobin.

  5. Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT)

    Time frame: Up to approximately 86 months

    Blood samples will be collected to determine the concentration of creatinine, total bilirubin, and ALT.

  6. Change From Baseline in Body Weight

    Time frame: Baseline and up to approximately 86 months

    Change from baseline in body weight will be reported.

  7. Change From Baseline in Blood Pressure

    Time frame: Baseline and up to approximately 86 months

    Change from baseline in systolic and diastolic blood pressure will be reported.

  8. Change From Baseline in Electrocardiogram (ECG)

    Time frame: Baseline and up to approximately 86 months

    Change from baseline in ECG (12-lead) for the determination of Fridericia's corrected QT interval (QTcF) will be reported.

Secondary outcomes

  1. Change From Baseline in 6-Minute Walk Distance (6MWD)

    Time frame: Baseline and up to approximately 48 months

    The 6MWD is the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD will be reported.

  2. Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels

    Time frame: Baseline and up to approximately 48 months

    NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP levels will be reported.

  3. Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/ World Health Organization Classification of Functional Status (WHO FC)

    Time frame: Baseline and up to approximately 48 months

    The severity of participant's PAH symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform physical activity without any symptoms, dyspnea at rest). Participants will be classified as "Improved", "No change", or "Worsened". Improved = reduction in WHO FC; No Change = no change in WHO FC; Worsened = increase in WHO FC. The change from baseline in the percentage of participants who improve or show maintenance in WHO FC will be reported.

  4. Change From Baseline in Pulmonary Vascular Resistance (PVR)

    Time frame: Baseline and up to approximately 48 months

    PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization. The change from baseline in PVR will be reported.

  5. Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator

    Time frame: Baseline and up to approximately 48 months

    The simplified French Risk scoring system is based on the 2015 European Society of Cardiology/European Respiratory Society guidelines for the diagnosis and treatment of pulmonary hypertension (PH). Noninvasive parameters (WHO FC, 6MWD, NT-proBNP levels) will be used to determine the score. 'Low risk' is defined as maintaining or achieving all 3 low-risk criteria: WHO FC I or II, 6MWD >440 meters, and NT-proBNP <300 ng/L. The change from baseline in percentage of participants who maintain or achieve a low risk simplified French Risk score will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

Acronym: SOTERIA

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Oct 20, 2025
Registry last updated
Jul 28, 2026

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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