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Completed Phase 2 Interventional Results available

A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

ClinicalTrials.gov ID: NCT04945460

Public ClinicalTrials.gov record NCT04945460. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

Study identification

NCT ID
NCT04945460
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
165 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 29, 2021 (Actual)
Primary completion
Sep 5, 2025 (Actual)
Completion
Apr 9, 2026 (Actual)
Last update posted
Sep 23, 2026

2021 – 2026

United States locations

U.S. sites
56
U.S. states
32
U.S. cities
49
Facility City State ZIP Site status
PULMONARY ASSOCIATES, P.A. ( Site 1008) Phoenix Arizona 85032 —
University of Arizona ( Site 1006) Tucson Arizona 85724-0001 —
Scripps Clinic ( Site 4001) La Jolla California 92037-1205 —
Cedars Sinai Medical Center ( Site 1082) Los Angeles California 90048 —
University of California Irvine ( Site 1086) Orange California 92868 —
Jeffrey S.Sager MD Medical Corporation ( Site 1060) Santa Barbara California 93105-5311 —
Stanford University ( Site 1024) Stanford California 94305 —
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028) Torrance California 90502 —
University Of Colorado ( Site 1013) Aurora Colorado 80045 —
South Denver Cardiology Associates ( Site 1091) Littleton Colorado 80120 —
Winchester Chest Clinic ( Site 1093) New Haven Connecticut 06519-1304 —
The George Washington University Medical Faculty Associates ( Site 1025) Washington D.C. District of Columbia 20037-3201 —
Bay Area Cardiology ( Site 1071) Brandon Florida 33511 —
Mayo Clinic Jacksonville - PPDS ( Site 1045) Jacksonville Florida 32224 —
AdventHealth Orlando ( Site 1058) Orlando Florida 32803 —
Tampa General Hospital ( Site 1043) Tampa Florida 33606 —
Piedmont Atlanta Hospital ( Site 1085) Atlanta Georgia 30309-1281 —
Emory University ( Site 1030) Atlanta Georgia 30322-1013 —
Saint Alphonsus Regional Medical Center ( Site 1097) Boise Idaho 83704-8880 —
University of Illinois Hospital ( Site 1095) Chicago Illinois 60612 —
IU Health Advanced Heart and Lung Care ( Site 1092) Indianapolis Indiana 46202-1218 —
Ascension Medical Group St. Vincent ( Site 1076) Indianapolis Indiana 46260 —
University of Iowa Hospital and Clinics ( Site 1050) Iowa City Iowa 52242 —
University of Kansas Medical Center ( Site 1020) Kansas City Kansas 66160 —
Norton Pulmonary Specialists ( Site 1066) Louisville Kentucky 40202 —
University of Louisville ( Site 1099) Louisville Kentucky 40202 —
University Medical Center New Orleans ( Site 1057) New Orleans Louisiana 70112 —
Tufts Medical Center - PPDS ( Site 1012) Boston Massachusetts 02111 —
Brigham and Women's Hospital [Boston, MA] ( Site 1014) Boston Massachusetts 02115 —
University of Michigan ( Site 1011) Ann Arbor Michigan 48109 —
University of Minnesota Hospitals ( Site 1062) Minneapolis Minnesota 55455 —
Washington University School of Medicine [Saint Louis, MO] ( Site 1022) St Louis Missouri 63110 —
University of Nebraska Medical Center ( Site 1053) Omaha Nebraska 68198 —
Pulmonary Health Physicians ( Site 1080) Liverpool New York 13088 —
Weill Cornell Medical College ( Site 1046) New York New York 10021-9800 —
University of Rochester Medical Center - PPDS ( Site 1039) Rochester New York 14642 —
Duke University Medical Center ( Site 1026) Durham North Carolina 27710-4000 —
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) Cincinnati Ohio 45219 —
University Hospitals Cleveland Medical Center ( Site 1005) Cleveland Ohio 44106 —
Cleveland Clinic Foundation ( Site 1065) Cleveland Ohio 44195 —
The Ohio State University Wexner Medical Center ( Site 1032) Columbus Ohio 43210 —
University of Toledo Medical Center ( Site 1070) Toledo Ohio 43614 —
Oregon Health Science University ( Site 1054) Portland Oregon 97126 —
Allegheny General Hospital ( Site 1088) Pittsburgh Pennsylvania 15212-4737 —
Lankenau Institute for Medical Research ( Site 1089) Wynnewood Pennsylvania 19096 —
Rhode Island Hospital ( Site 1033) Providence Rhode Island 02903 —
Medical University of South Carolina - PPDS ( Site 1003) Charleston South Carolina 29425-0001 —
Statcare Pulmonary Consultants - Knoxville ( Site 1031) Knoxville Tennessee 37919 —
Baylor University Medical Center ( Site 1096) Dallas Texas 75246 —
University of Texas Southwestern Medical Center ( Site 4002) Dallas Texas 75390 —
Intermountain Medical Center ( Site 1079) Murray Utah 84107 —
Inova Heart and Vascular Institute ( Site 1078) Falls Church Virginia 22042 —
Bon Secours St. Mary's Hospital ( Site 1069) Richmond Virginia 23226 —
West Virginia University ( Site 1081) Morgantown West Virginia 26506 —
Aurora St Luke's Medical Center ( Site 1083) Milwaukee Wisconsin 53215 —
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051) Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04945460, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 23, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04945460 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →