Recruiting

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

ClinicalTrials.gov IDNCT07218029

PhasePHASE3

Enrollment815

SponsorMerck Sharp & Dohme LLC

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Pulmonary Arterial Hypertension

About this study

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.

Interventions

Biological: Sotatercept — Sotatercept SC injection every 3 weeks

Primary outcomes

Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 90 months)
Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 86 months)
Number of Participants with Detectable Anti-Drug Antibodies (ADAs) (Up to approximately 88 months)
Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin (Up to approximately 88 months)
Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT) (Up to approximately 86 months)
Change From Baseline in Body Weight (Baseline and up to approximately 86 months)
Change From Baseline in Blood Pressure (Baseline and up to approximately 86 months)
Change From Baseline in Electrocardiogram (ECG) (Baseline and up to approximately 86 months)

Eligibility information

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

Study locations

Pulmonary Associates, PA ( Site 1008), Phoenix, Arizona 85032 United States
Arizona Pulmonary Specialists ( Site 1010), Scottsdale, Arizona 85258 United States
University of Arizona ( Site 1006), Tucson, Arizona 85724-0001 United States
University of California San Diego Health ( Site 1002), La Jolla, California 92039 United States
UC Irvine Health Medical Center ( Site 1086), Orange, California 92868 United States
UC Davis - Medial Center ( Site 1064), Sacramento, California 95817 United States
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019), San Francisco, California 94143 United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060), Santa Barbara, California 93105-5316 United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028), Torrance, California 90502 United States
University of Colorado Hospital ( Site 1013), Aurora, Colorado 80045 United States

Showing 10 of 137 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.