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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) (NCT07218029) is a Phase 3 interventional studying Pulmonary Arterial Hypertension, sponsored by Merck Sharp & Dohme LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Pulmonary Arterial Hypertension, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 815 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

Sotatercept

Sotatercept SC injection every 3 weeks

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
University of California San Diego Health ( Site 1002)
La Jolla, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
San Francisco, California, United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
Torrance, California, United States
University of Colorado Hospital ( Site 1013)
Aurora, Colorado, United States
Mayo Clinic Jacksonville ( Site 1045)
Jacksonville, Florida, United States
AdventHealth Orlando ( Site 1058)
Orlando, Florida, United States
University of Kansas Medical Center ( Site 1020)
Kansas City, Kansas, United States
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States
Tufts Medical Center ( Site 1012)
Boston, Massachusetts, United States
University Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States
Weill Cornell Medical Center ( Site 1046)
New York, New York, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
University of Cincinnati Medical Center ( Site 1035)
Cincinnati, Ohio, United States
Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio, United States
Oregon Health & Science University ( Site 1054)
Portland, Oregon, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
Houston, Texas, United States
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes, Buenos Aires, Argentina
Instituto Médico Río Cuarto ( Site 1907)
Río Cuarto, Córdoba Province, Argentina

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07218029), the sponsor (Merck Sharp & Dohme LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07218029 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07218029?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07218029?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07218029. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07218029. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.