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Extension Study of Sotatercept for Pulmonary Hypertension

This study is for people with a type of pulmonary hypertension (high blood pressure in the lungs) called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH) caused by heart failure with preserved ejection fraction (HFpEF). Researchers are studying sotatercept, given as a subcutaneous injection (under the skin), to see if it can treat Cpc-PH. This is an extension study, meaning you can join if you previously participated in a specific sotatercept study (MK-7962-007 or MK-7962-041) and completed it without stopping the treatment. The main goal is to track how many participants experience side effects or stop treatment due to side effects over a long period, up to approximately 10 years. The study is currently recruiting 440 participants.

Study design
This is an interventional extension study for people who previously participated in a sotatercept study. It plans to enroll 440 participants.
What's involved
You would receive sotatercept via subcutaneous injection and your health will be followed for up to approximately 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 10 years to monitor adverse events and treatment discontinuation.

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NCT06814145

Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~440 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Sotatercept

At a glance

Recruiting sites
0 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience an Adverse Event (AE)
Measured over Up to approximately 10 years
+1 more outcome measured

Conditions

Hypertension, Pulmonary

Explore related trials

Pulmonary Hypertension

Where it's being run

57 sites across 43 states
Israel5
Spain4
California3
Ohio3
Pennsylvania2
Virginia2
Italy2
Arizona1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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 and has an ongoing SAE that occurred during parent study and is suspected to be related to study intervention
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

What this trial measures

  • Number of Participants Who Experience an Adverse Event (AE)Up to approximately 10 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  • Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 10 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.