Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) (NCT06814145) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
United States, Belgium, Canada130 participantsStarted 2025-04-16
Plain-language summary
Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF).
Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time.
The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
\- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
* Has had a study intervention interruption
* Is pregnant or breastfeeding
* Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
* Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
* Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
* Anticipated or undergone heart transplant or ventricular assist device implantation
* Has had prior exposure to luspatercept
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an extension study for sotatercept, does my history with the drug or my current treatment plan make me a candidate worth discussing for this kind of continued-treatment study?
2The trial is no longer enrolling new participants — does that mean there's no realistic path for me to access sotatercept through this specific study, and what other options might exist?
3The main things being tracked in this trial are adverse events and treatment discontinuations due to side effects — what kinds of safety concerns have already shown up with sotatercept that I should know about before deciding if this approach is right for me?
4Since this is a Phase 2 extension study, how does that affect what we know about long-term safety and whether the benefits seen so far would likely hold up over time for someone in my situation?
5Given that this trial focuses on pulmonary hypertension, how does my specific type and severity of pulmonary hypertension compare to what this study is designed to evaluate, and would standard approved treatments be a more appropriate starting point for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experience an Adverse Event (AE)
Timeframe: Up to approximately 187 weeks
2
Number of Participants Who Discontinue Study Treatment Due to an AE