Pulmonary HypertensionPhase 3CHORUSNCT07839585

A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041)

A Phase 3 study testing Sotatercept in people with Pulmonary Hypertension, run by Merck Sharp & Dohme LLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Pulmonary Hypertension
What is being tested?: Sotatercept
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 352 participants
Where: No sites listed yet
Study dates: 26 Nov 2026to 14 Jun 2030
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The main inclusion criteria include but are not limited to the following:
Has clinical diagnosis of HF with preserved ejection fraction on optimized guideline-directed medical therapy
Has CpcPH confirmed by right-heart catheterization
Has NYHA FC II or III

Who cannot join

The main exclusion criteria include but are not limited to the following:
Has a diagnosis of PH in World Health Organization Group 1, 3, 4, or 5
Has CV comorbidities:
History of surgical or transcatheter correction of mitral or aortic stenosis or regurgitation within 12 months before Screening
More than one valve replacement or repair (mechanical or bioprosthetic), or anticipated valve replacement or repair during the study
History of serious, life-threatening, or hemodynamically significant arrhythmia, long corrected QT interval syndrome, or Brugada syndrome

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History of hypertrophic cardiomyopathy, infiltrative cardiomyopathy (including, but not limited to, cardiac amyloidosis), dilated cardiomyopathy, arrhythmogenic ventricular cardiomyopathy, or restrictive cardiomyopathy
History or evidence of chronic liver disease
Has a current diagnosis of end-stage renal disease
History of organ transplantation (except corneal transplant) or bone marrow transplantation ≤5 years before Screening or has a life expectancy of <12 months
History of malignancy ≤5 years before Screening, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or ≤2 squamous cell carcinomas of the skin
Has any noncardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits their ability to perform the 6-minute walk test
Has moderate or severe obstructive sleep apnea
Has a body mass index ≥50 kg/m^2
Has been treated with any approved pulmonary arterial hypertension-specific medications within 30 days of Randomization
Has background medication with the following agents: sodium-glucose cotransporter-2 inhibitor, renin-angiotensin-aldosterone system inhibitors, mineralocorticoid receptor antagonists, diuretics, and beta-blockers, that is not a stable dose for ≥30 days before Randomization

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sotatercept in Adults With Combined Postcapillary and Precapillary Pulmonary Hypertension (CpcPH) and Heart Failure With Preserved Ejection Fraction (HFpEF)

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.

Read the detailed description

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.

Conditions: Pulmonary Hypertension
Being tested: Sotatercept, Placebo
Medical subject headings: Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SotaterceptBiological
Also called MK-7962, WINREVAIR™, ACE-011
SC injection administered every 3 weeks.
PlaceboBiological
SC injection administered every 3 weeks.

Study groups in NCT07839585
Study group	Role	What they receive
Sotatercept	Experimental	Participants will receive sotatercept 0.3 mg/kg via subcutaneous (SC) injection every 3 weeks until end of study (up to approximately 37 months). Receives: Biological: Sotatercept
Placebo	Placebo comparator	Participants will receive matching placebo via SC injection every 3 weeks until end of study (up to approximately 37 months). Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to ~37 months

Secondary outcomes (11)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to ~37 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 202614 Jun 2030

First posted24 Sep 2026
Study start26 Nov 2026 (estimated)
Primary completion8 Jan 2030 (estimated)
Study completion14 Jun 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 352 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07839585
Sponsor's protocol ID: 7962-041
Other IDs: MK-7962-041, 2025-524634-25-00, U1111-1331-4324, 2025
Acronym: CHORUS
Status last verified: Oct 2026
First submitted: 18 Sep 2026
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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