NCT07839585Not yet recruitingPhase 3
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, 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)
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 352 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- 26 Nov 2026
- Primary completion date
- 8 Jan 2030
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT07839585
- EU CT number
- 2025-524634-25-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 352
- From 26 Nov 2026 to the primary completion date, 8 Jan 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has been treated with any approved pulmonary arterial hypertension-specific medications within 30 days of Randomization
Other illness
- History or evidence of chronic liver disease
- Has a current diagnosis of end-stage renal disease
- Has any noncardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits their ability to perform the 6-minute walk test
Lab values
- 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
- History of hypertrophic cardiomyopathy, infiltrative cardiomyopathy (including, but not limited to, cardiac amyloidosis), dilated cardiomyopathy, arrhythmogenic ventricular cardiomyopathy, or restrictive cardiomyopathy
- 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
Age
- 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
Other
- 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 moderate or severe obstructive sleep apnea
- Has a body mass index ≥50 kg/m\^2
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.