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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) (NCT06814145) is a Phase 2 interventional studying Hypertension, Pulmonary, sponsored by Merck Sharp & Dohme LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF). Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time. The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hypertension, Pulmonary and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 130 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Hypertension, Pulmonary subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: The main inclusion criteria include but are not limited to the following: \- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE) Who Should NOT Join This Trial: The main exclusion criteria include but are not limited to the following: - 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 - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * 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 * 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

Treatments Being Tested

BIOLOGICAL

Sotatercept

subcutaneous injection

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California, United States
Stanford University Medical Center ( Site 1024)
Stanford, California, United States
South Denver Cardiology Associates ( Site 1091)
Littleton, Colorado, United States
Yale New Haven Hospital ( Site 1093)
New Haven, Connecticut, United States
AdventHealth Orlando ( Site 1058)
Orlando, Florida, United States
The Emory Clinic ( Site 1030)
Atlanta, Georgia, United States
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States
University Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States
Weill Cornell Medical Center ( Site 1046)
New York, New York, United States
Duke University Medical Center ( Site 1026)
Durham, North Carolina, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation. ( Site 1065)
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio, United States
Allegheny General Hospital ( Site 1088)
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center ( Site 1089)
Wynnewood, Pennsylvania, United States
Rhode Island Hospital ( Site 1039)
Providence, Rhode Island, United States
Medical University of South Carolina ( Site 1003)
Charleston, South Carolina, United States
Statcare Pulmonary Consultants ( Site 1031)
Knoxville, Tennessee, United States
Intermountain Medical Center ( Site 1079)
Murray, Utah, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06814145), the sponsor (Merck Sharp & Dohme LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06814145 clinical trial studying?

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF). Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept a… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06814145?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06814145?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06814145. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06814145. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.