A Phase 3 interventional study of Sotatercept and Placebo in Pulmonary Hypertension, sponsored by Merck Sharp & Dohme LLC. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
Researchers are looking for other ways to treat people with combined postcapillary and precapillary pulmonary hypertension (CpcPH). This trial focuses on CpcPH that is related to heart failure with preserved ejection fraction (HFpEF). The goal of the study is to learn if participants who receive sotatercept live longer without their CpcPH-HFpEF getting worse than those who receive placebo.
Participants will have the option to continue or start treatment with sotatercept in the extension study, MK-7962-023 (NCT06814145), after completing the End of Treatment visit.
1,091 studies on the registry are indexed under Hypertension, Pulmonary; 243 are open to participants now.
This study's planned enrollment of 352 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 502 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has CV comorbidities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive sotatercept 0.3 mg/kg via subcutaneous (SC) injection every 3 weeks until end of study (up to approximately 37 months).
Biological: Sotatercept
Participants will receive matching placebo via SC injection every 3 weeks until end of study (up to approximately 37 months).
Biological: Placebo
SC injection administered every 3 weeks.
Also known as: MK-7962, WINREVAIR™, ACE-011
SC injection administered every 3 weeks.
Time to Clinical Worsening (TTCW)
TTCW was defined as time to first occurrence of any of the following events: cardiovascular (CV) death, hospitalization due to worsening heart failure (HF) or pulmonary hypertension (PH), urgent visits due to worsening HF or PH, or deterioration in exercise capacity (≥15% decrease from baseline in 6-minute walk distance \[6MWD\], confirmed by 2 tests) due to worsening HF or PH. CV deaths are defined as any deaths with a primary CV cause, including acute myocardial infarction (MI), sudden cardiac death, HF, PH worsening, stroke, and other CV causes.
Time frame: Up to ~37 months
Time to First Event of CV Death, Hospitalization Due to Worsening HF or PH, or Urgent Visit Due to Worsening HF or PH
CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to first event of CV death, hospitalization due to worsening HF or PH, or urgent visit due to worsening HF or PH will be presented.
Time frame: Up to ~37 months
Time to First Event of CV Death or Hospitalization Due to Worsening HF or PH
CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to first event of CV death or hospitalization due to worsening HF or PH will be presented.
Time frame: Up to ~37 months
Change From Baseline in 6MWD at Week 24
The 6MWD tests the distance walked in 6 minutes as an assessment of exercise capacity. The baseline value for 6MWD is the average of the 2 values collected during Screening. The change from baseline in 6MWD at Week 24 will be presented.
Time frame: Baseline and Week 24
Time to the Date of Death Due to Any Cause
The time to date of death (all causes) will be presented.
Time frame: Up to ~37 months
Time to First Hospitalization Due to Worsening HF or PH
The time to first hospitalization due to worsening HF or PH will be presented.
Time frame: Up to ~37 months
Time to First Urgent Visit Due to Worsening HF or PH
The time to first urgent visit due to worsening HF or PH will be presented.
Time frame: Up to ~37 months
Percentage of Participants Maintaining and/or Improving New York Heart Association (NYHA) Functional Class (FC) at Week 24
NYHA FC classifies the extent of heart failure. The percentage of participants maintaining and/or improving NYHA FC at Week 24 will be presented.
Time frame: Week 24
Change From Baseline in N-Terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Levels at Week 24
NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP levels at Week 24 will be presented.
Time frame: Baseline and Week 24
Number of Participants Who Experience One or More Adverse Events (AEs)
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 presented.
Time frame: Up to ~37 months
Number of Participants Who Discontinue Study Intervention Due to an AE
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 presented.
Time frame: Up to ~37 months
Time to CV Death
CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to CV death will be presented.
Time frame: Up to ~37 months
No study locations are listed for this record.
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Start is estimated for Nov 2026; primary completion for Jan 2030, 37 months later.
Of 31 phase 3 interventional studies under Hypertension, Pulmonary, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 83. This study's planned 37 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sotatercept