Recruiting
Phase 3

Sotatercept

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07218029

Conditions

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sotatercept

Study Details

Brief summary:

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.

Conditions

Pulmonary Arterial Hypertension

Study ID

NCT07218029

Start date

May 12, 2021

Status verified date

Sep, 2026

Completion date

Dec 7, 2028

Anticipated

Primary completion date

Dec 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

815 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sotatercept

Participants enrolling from blinded PAH sotatercept studies will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection and can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study. Participants enrolling from unblinded PAH sotatercept studies will continue sotatercept at their current dose and, if at a dose <0.7 mg/kg, can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study.

Interventions

Sotatercept

Sotatercept SC injection every 3 weeks

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Arizona Pulmonary Specialists ( Site 1010)

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Study Coordinator

602-271-0832

UC Davis - Medial Center ( Site 1064)

Recruiting

Sacramento, California, United States, 95817

Contacts

Study Coordinator

916-734-1554

The Emory Clinic ( Site 1030)

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Study Coordinator

404-712-8204

Brigham and Women's Hospital ( Site 1014)

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Study Coordinator

617-525-9733

St. Joseph's Healthcare Hamilton ( Site 2105)

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Study Coordinator

905-522-1155

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.