A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
Recruiting
Phase 3Interventional Study
Pulmonary Arterial Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
815 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for
This trial is looking for people who have completed a previous study with sotatercept for pulmonary arterial hypertension (PAH). Participants will be monitored for the long-term safety and tolerance of sotatercept along with their usual PAH treatments.
Are You a Good Fit for This Trial?
You may be able to join if
I have completed my previous PAH sotatercept study.
I am willing to attend all study visits.
I can understand and provide my consent.
You may not be able to join if
I did not participate in a parent study for sotatercept.
I missed more than 4 doses after my last study.
I have an ongoing serious health issue related to sotatercept.
I am pregnant or breastfeeding.
I am or have a family member who works with this study.
I am enrolled in another investigational product study.
I am incapacitated.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 s…
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.
Trial Locations
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Eligibility 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 w…
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
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