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)

NCT07839585 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 7962-041MK-7962-041
• Study Type: interventional
• Target: 352
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to ~37 weeks

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

  Up to ~37 weeks

• Time to First Event of CV Death or Hospitalization Due to Worsening HF or PH

  Up to ~37 weeks

• Change From Baseline in 6MWD at Week 24

  Baseline and Week 24

• Time to the Date of Death Due to Any Cause

  Up to ~37 weeks

• Time to First Hospitalization Due to Worsening HF or PH

  Up to ~37 weeks

Study Arms (2)

Sotatercept

EXPERIMENTAL

Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg until end of study (up to approximately 37 months).

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).

Biological: Placebo

Interventions

Sotatercept BIOLOGICAL

SC injection administered every 3 weeks.

Also known as: MK-7962, WINREVAIR™, ACE-011

Sotatercept

Placebo BIOLOGICAL

SC injection administered every 3 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): November 26, 2026
• Primary Completion (Estimated): January 8, 2030
• Study Completion (Estimated): June 14, 2030
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share