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Long-term sotatercept treatment for people with pulmonary arterial hypertension

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)

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT07218029

This follow-up study will test whether long-term sotatercept is safe and tolerable for people with pulmonary arterial hypertension who completed earlier sotatercept studies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment815 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations107 sites (Phoenix, Arizona and 106 other locations)
Trial IDNCT07218029 on ClinicalTrials.gov

What this trial studies

This long-term follow-up enrolls people who completed prior sotatercept PAH trials to continue receiving sotatercept alongside their standard PAH medicines. Participants will attend regular clinic visits for monitoring of adverse events, laboratory tests, and overall tolerability over an extended period. The primary aim is to collect long-term safety and tolerability data rather than to compare efficacy against a control. Enrollment is restricted to those who did not discontinue their parent study and who meet routine eligibility checks such as pregnancy status and recent dosing history.

Who should consider this trial

Good fit: Ideal candidates are people with pulmonary arterial hypertension who completed a prior sotatercept parent study without early discontinuation and can attend scheduled follow-up visits.

Not a fit: People who did not participate in a sotatercept parent study, who had serious sotatercept-related adverse events, missed more than four consecutive doses before entry, or who are pregnant or breastfeeding are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the study could confirm that sotatercept is safe and tolerable when taken long-term with standard PAH treatments, supporting its use as a durable therapy option.

How similar studies have performed: Earlier clinical trials of sotatercept in PAH reported promising clinical effects, but long-term safety and tolerability data are still being gathered.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 106 other locations

+57 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Arterial Hypertension
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.