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

• ClinicalTrials.gov Identifier: NCT04945460
• Recruitment Status: Recruiting
• First Posted: June 30, 2021
• Last Update Posted: April 26, 2024
• Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
• Information provided by (Responsible Party): Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Hypertension, Pulmonary	Drug: Sotatercept 0.3 mg/kg; Drug: Placebo; Drug: Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg	Phase 2

Detailed Description:

Participants enrolled in the study will have a diagnosis of Cpc-PH due to HFpEF with New York Heart Association (NYHA) functional class (FC) II or III. Participants will be randomly assigned in a 1:1:1 ratio to 1 of the 3 treatment groups (placebo, 0.3mg/kg sotatercept and 0.7mg/kg sotatercept) during the placebo-controlled Treatment Period. In the extension phase, sotatercept-treated participants will continue on their current dose. Placebo participants will be re-randomized in a 1:1 ratio to one of the two sotatercept treatment groups utilized in the placebo-controlled Treatment Period. Each participant will be enrolled in the study for up to 114 weeks, including a 28-day Screening Period, a 24-week, double-blind, placebo-controlled Treatment Period, an 18-month Extension Period, and an 8-week Follow-up Period.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Each eligible participant will be randomly assigned in a 1:1:1 ratio to 1 of the 3 treatment groups during the Treatment Period:

Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 3 weeks (Q3W) for 24 weeks

Arm 2: Treatment Group 2: Sotatercept SC at a dose level of 0.3 mg/kg Q3W for 24 weeks

Arm 3: Treatment Group 3: Sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and Q3W for the remainder of the 24-week Treatment Period

• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: December 29, 2021
• Estimated Primary Completion Date: October 31, 2025
• Estimated Study Completion Date: February 20, 2027

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Delivered subcutaneously (SC) every 3 weeks (Q3W) for 24 weeks in the placebo-controlled treatment period. After completion of the placebo-controlled treatment period, placebo participants will enter into 1 of the 2 sotatercept dose groups in an extension period.	Drug: Placebo; Administered by subcutaneous injection
Experimental: Sotatercept 0.3 mg/kg; Participants will receive sotatercept SC at a dose level of 0.3 mg/kg Q3W for 24 weeks in the placebo-controlled treatment period. After completion of the placebo-controlled treatment period, participants will continue to receive sotatercept SC at a dose level of 0.3 mg/kg Q3W in an extension period for up to 18 months.	Drug: Sotatercept 0.3 mg/kg; Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.; Other Name: ACE-011
Experimental: Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg; Sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and Q3W for the remainder of the 24-week treatment Period.	Drug: Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg; Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.; Other Name: ACE-011
Experimental: Extension Period: Placebo Crossed Over to Sotatercept 0.3 mg/kg; After the placebo-controlled treatment period, placebo participants will cross over to receive sotatercept SC at a dose of 0.3 mg/kg Q3W for up to 18 months in an extension period.	Drug: Sotatercept 0.3 mg/kg; Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.; Other Name: ACE-011
Experimental: Extension Period: Placebo Crossed Over to Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg; After the placebo-controlled treatment period, placebo participants will cross over to receive sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and then Q3W for up to 18 months in an extension period.	Drug: Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg; Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.; Other Name: ACE-011

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 [ Time Frame: Baseline and Week 24 ]
   PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC).

Secondary Outcome Measures :

1. Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 24 [ Time Frame: Baseline and Week 24 ]
   The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity.
2. Time to First Clinical Worsening Event (TTCW) at Weeks 24 [ Time Frame: Week 24 ]

   Clinical Worsening events are defined as the number of weeks from first dose date to any of the following:

   • Hospitalization due to a cardiopulmonary indication (a non-elective hospitalization lasting at least 24 hours in duration caused by clinical conditions directly related to Pulmonary Hypertension and/or Heart Failure)
   • Administration of intravenous diuretics or subcutaneous (SC) furosemide
   • Death (all causes)
   • Decrease in 6 minute walk distance (6MWD) by ≥ 15% from baseline confirmed by 2 tests at least 4 hours, but no more than 1 week apart.
3. Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 24 [ Time Frame: Baseline and Week 24 ]
   mPAP is calculated from systolic and diastolic pulmonary artery pressure measured by right heart catheterization.
4. Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 24 [ Time Frame: Baseline and Week 24 ]
   PCWP is an indirect estimate of left atrial pressure measured in right heart catheterization.
5. Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 24 [ Time Frame: Baseline and Week 24 ]
   TAPSE is an echocardiographic measurement of tricuspid valve annulus movement, as an indicator of right heart function.
6. Change From Baseline in Right Ventricular Fractional Area Change (RVFAC) at Week 24 [ Time Frame: Baseline and Week 24 ]
   RVFAC is an echocardiographic measurement of percent change between right ventricular area during diastole and systole, as an indicator of right heart function.
7. Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 24 [ Time Frame: Baseline and Week 24 ]
   LVEF is an echocardiographic measurement of percent change between left ventricular volume during diastole and systole, as an indicator of left heart function.
8. Change From Baseline in Isovolumic Relaxation Time (IVRT) at Week 24 [ Time Frame: Baseline and Week 24 ]
   IVRT is an echocardiographic measurement of the interval between closure of the aortic valve, to onset of filling by opening of the mitral valve. It is used as an indicator of diastolic dysfunction.
9. Change From Baseline in ratio of mitral inflow velocity I to mitral annular velocity'(e') (E/e' ratio) at Week 24 [ Time Frame: Baseline and Week 24 ]
   E/e' is a ratio measured in echocardiography as an indicator of diastolic function.
10. Change From Baseline in the Ratio of the Peak Velocity Flow of the E Wave in Early Diastole to Peak Velocity Flow of the A Wave in Late Diastole (E/A Ratio) at Week 24 [ Time Frame: Baseline and Week 24 ]
    E/A is a ratio measured in echocardiography as an indicator of diastolic function.
11. Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 24 [ Time Frame: Baseline and Week 24 ]
    NT-proBNP is a circulating biomarker that reflects myocardial stretch.
12. Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 24 [ Time Frame: Baseline and Week 24 ]
    NYHA FC classifies the extent of heart failure.
13. Change From Baseline in Dyspnea Score As Assessed by Borg Category Ratio 10 Scale® at Week 24 [ Time Frame: Baseline and Week 24 ]
    The Borg Category Ratio 10 Scale assesses the severity of shortness of breath as perceived by the participant. The scale is from 0-10 with a higher number indicating more severe dyspnea.
14. Change From Baseline in Myocardial Contraction Fraction (MCF) at Week 24 [ Time Frame: Baseline and Week 24 ]
    MCF is an echocardiographic measurement that determines the ratio of left ventricular stroke volume to myocardial volume and is an indicator of left ventricular systolic function.
15. Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48 [ Time Frame: Baseline and Week 48 ]
    The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity.
16. Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48 [ Time Frame: Baseline and Week 48 ]
    PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization.
17. Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 48 [ Time Frame: Baseline and Week 48 ]
    mPAP is calculated from systolic and diastolic pulmonary artery pressure measured by right heart catheterization.
18. Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 48 [ Time Frame: Baseline and Week 48 ]
    PCWP is an indirect estimate of left atrial pressure measured in right heart catheterization.
19. Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 48 [ Time Frame: Baseline and Week 48 ]
    TAPSE is an echocardiographic measurement of tricuspid valve annulus movement, as an indicator of right heart function.
20. Change From Baseline in Right Ventricular Fractional Area Change (RVFAC) at Week 48 [ Time Frame: Baseline and Week 48 ]
    RVFAC is an echocardiographic measurement of percent change between right ventricular area during diastole and systole, as an indicator of right heart function.
21. Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 48 [ Time Frame: Baseline and Week 48 ]
    LVEF is an echocardiographic measurement of percent change between left ventricular volume during diastole and systole, as an indicator of left heart function.
22. Change From Baseline in Isovolumic Relaxation Time (IVRT) at Week 48 [ Time Frame: Baseline and Week 48 ]
    IVRT is an echocardiographic measurement of the interval between closure of the aortic valve, to onset of filling by opening of the mitral valve. It is used as an indicator of diastolic dysfunction.
23. Change From Baseline in E/e' (Early Mitral Inflow Velocity E and Mitral Annular Early Diastolic Velocity e') Ratio at Week 48 [ Time Frame: Baseline and Week 48 ]
    E/e' is a ratio measured in echocardiography as an indicator of diastolic function.
24. Change From Baseline in the Ratio of the Peak Velocity Flow of the E Wave in Early Diastole to Peak Velocity Flow of the A Wave in Late Diastole (E/A Ratio) at Week 48 [ Time Frame: Baseline and Week 48 ]
    E/A is a ratio measured in echocardiography as an indicator of diastolic function.
25. Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48 [ Time Frame: Baseline and Week 48 ]
    NT-proBNP is a circulating biomarker that reflects myocardial stretch.
26. Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48 [ Time Frame: Baseline and Week 48 ]
    NYHA FC classifies the extent of heart failure.
27. Change From Baseline in Myocardial Contraction Fraction (MCF) at Week 48 [ Time Frame: Baseline and Week 48 ]
    MCF is an echocardiographic measurement that determines the ratio of left ventricular stroke volume to myocardial volume and is an indicator of left ventricular systolic function.
28. Change From Baseline in Pulmonary Vascular Resistance (PVR) for the Placebo Crossed Over to Sotatercept Cohorts at Week 48 of the Extension Period [ Time Frame: Baseline and Week 48 of the Extension Period ]
    PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization.
29. Change From Baseline in the 6-minute walk distance (6MWD) for the Placebo Crossed Over to Sotatercept Cohorts at Week 48 of the Extension Period [ Time Frame: Baseline and Week 48 of the Extension Period ]
    The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity.
30. Change From Baseline in New York Heart Association Functional Class (NYHA FC) for the Placebo Crossed Over to Sotatercept Cohorts at Week 48 of the Extension Period [ Time Frame: Baseline and Week 48 of the Extension Period ]
    NYHA FC classifies the extent of heart failure.
31. Change in Pulmonary Vascular Resistance (PVR) for the Placebo Crossed Over to Sotatercept Cohorts From Week 24 to Week 48 of the Extension Period [ Time Frame: From Week 24 to Week 48 of the Extension Period ]
    PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization.
32. Change in 6-minute Walk Distance (6MWD) for the Placebo Crossed Over to Sotatercept Cohorts From Week 24 to Week 48 of the Extension Period [ Time Frame: From Week 24 to Week 48 of the Extension Period ]
    The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity.
33. Change in New York Heart Association Functional Class (NYHA FC) for the Placebo Crossed Over to Sotatercept Cohorts From Week 24 to Week 48 of the Extension Period [ Time Frame: From Week 24 to Week 48 of the Extension Period ]
    NYHA FC classifies the extent of heart failure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Participants must meet the following criteria to be enrolled in this proof-of-concept study:

1. Age 18 to 85 years

2. Clinical diagnosis of HFpEF:

   • Left ventricular ejection fraction ≥50%, with no history of LVEF below 45% in more than two consecutive measurements under stable conditions

3. Demonstrated Cpc-PH by all of the following:

   • Baseline RHC performed within 28 days of randomization documenting a minimum PVR of ≥320 dyn•sec/cm5 (4 wood units)
   • Mean pulmonary arterial pressure (mPAP) of >20 mmHg
   • Pulmonary capillary wedge pressure (PCWP) >15 mmHg but < 30 mmHg
4. New York Heart Association FC of II or III
5. Six-minute Walk Distance ≥100 m repeated twice during Screening and both values within 15% of each other, calculated from the highest value
6. Chronic medication for HF or for any underlying condition, administered at a stable (per investigator) dose for ≥30 days prior to Visit 1. Diuretics and/or anticoagulants are excepted from this rule but should not be newly started or stopped within 30 days of Visit 1, and a prescribed dose change should not occur within 7 days of Visit 1. Anticoagulation may be suspended for RHC if necessary.

7. Women of childbearing potential must:

   • Have 2 negative urine or serum pregnancy tests as verified by the investigator during the Screening Period; must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
   • If sexually active with a male partner: use highly effective contraception without interruption for at least 28 days prior to starting the investigational product AND agree to use the same highly effective contraception in combination with a barrier method during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment
   • Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug

8. Male participants must:

   • Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
   • Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug
9. Ability to adhere to the study visit schedule and understand and comply with all protocol requirements
10. Agreement to not participate in any other trials of investigational drugs/devices while enrolled in the A011-16 study
11. Ability to understand and provide documented consent for participation

Exclusion Criteria:

Participants will be excluded from the study if any of the following criteria are met:

1. A diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5

2. Documented significant lung disease:

   • Chronic obstructive pulmonary disease with post-bronchodilator forced expiratory volume in the first second (FEV1) <60% predicted
   • Restrictive lung disease with total lung capacity <70% predicted
   • More than mild interstitial lung disease (ILD), with FVC<70% or FEV1<60% predicted (still appropriate if absence of more than mild ILD, fibrosis, or COPD on computed tomography [CT] imaging)

3. Cardiovascular co-morbidities, which include any of the following:

   • History of more than mild mitral or aortic stenosis
   • Ongoing more than mild mitral or aortic regurgitation
   • More than one valve replacement or repair (mechanical or biomechanical) or anticipation of any valve replacement or repair
   • Severe tricuspid regurgitation due to primary valvular disease
   • Occurrence of myocardial infarction, acute coronary syndrome, coronary artery bypass graft or percutaneous coronary intervention within 180 days of Visit 1
   • History of serious life-threatening or hemodynamically significant arrhythmia
   • History of or anticipated heart transplant or ventricular assist device implantation
   • History of implantable cardioverter defibrillator placement or anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening
   • Anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening or history of implantable cardioverter defibrillator placement
   • Occurrence of myocardial infarction within 180 days of Visit 1
   • History of known pericardial constriction, hypertrophic cardiomyopathy, sarcoidosis, or amyloid cardiomyopathy
   • Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mmHg or sitting diastolic blood pressure >110 mmHg during Screening after a period of rest
   • Systemic hypotension as evidenced by sitting systolic blood pressure <90 mmHg or sitting diastolic blood pressure <50 mmHg during Screening
   • Resting heart rate of <45 bpm or >115 bpm
   • Stroke within 90 days of Visit 1
   • Acutely decompensated HF that required hospitalization within 30 days of Visit 1
   • Electrocardiogram during Screening Period with Fridericia's corrected QT interval (QTcF) >470 msec for males or >480 msec for females, or >500 msec if a ventricular conduction defect (right bundle branch block; left bundle branch block; or interventricular conduction delay) is present
   • Personal or family history of Brugada syndrome, sudden cardiac arrest or unexplained sudden cardiac death or arrest
   • Personal or family history of long QT syndrome unless the participant's ECG shows a normal QTc
   • Arrhythmogenic right ventricular dysplasia (ARVD) unless the participant has a recent cardiac MRI that shows no evidence of this diagnosis
4. Hospitalization for any worsening of medical conditions or any significant surgery per investigator within 30 days of Visit 1
5. Received any approved PAH-specific therapies (i.e., endothelin receptor antagonists, prostacyclin analogs, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators) within 30 days of Visit 1
6. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin,or levosimendan) within 30 days of Visit 1
7. Received erythropoietin within 6 months of Visit 1.The use of an oral phosphodiesterase type 5 inhibitor, if only indicated for erectile dysfunction, is permitted, if not administered within 48 hours of a study visit or procedure.
8. Known history of chronic liver disease, including untreated hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), with severe hepatic impairment and/or cirrhosis (e.g., hepatic encephalopathy)
9. Prior exposure to sotatercept or luspatercept
10. Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented consent
11. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days of Visit 1 or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)

12. Any of the following clinical laboratory values prior to Visit 1 as specified:

    • Hemoglobin (Hgb) above the gender-specific upper limit of normal (ULN) per local laboratory test within 28 days of Visit 1or <10 g/dL per local laboratory within 28 days of Visit 1
    • Serum alanine aminotransferase or aspartate aminotransferase levels >3× ULN or total bilirubin >3× ULN within 28 days of Visit 1
    • Estimated glomerular filtration rate <30 ml/min/1.73 m2 (4-variable Modification of Diet in Renal Disease equation) within 28 days of Visit 1 or required renal replacement therapy within 90 days of Visit 1
    • Glycated hemoglobin (HbA1c) >10% within 28 days of Visit 1
    • Platelet count < 75,000/mm3 within 28 days of Visit 1
13. History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in the investigational product
14. Major surgery within 60 days of Visit 1. Participants must have completely recovered from any previous surgery prior to Visit 1
15. Prior heart-lung transplants or life expectancy of <12 months
16. Pregnancy or breastfeeding in females
17. History of active malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or ≤ 2 squamous cell carcinomas of the skin
18. History of clinically significant (as determined by the investigator) endocrine, hematologic, hepatic, (auto)immune, infectious (requiring chronic antibiotics), metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or another disease that may limit participation in the study
19. Body mass index ≥50 kg/m2
20. Untreated or more than mild obstructive sleep apnea
21. Any non-cardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits the ability to perform 6-minute walk test (6MWT)

Contacts and Locations

Contacts

Contact: Toll Free Number; 1-888-577-8839; Trialsites@merck.com

Locations

United States, Arizona

PULMONARY ASSOCIATES, P.A. ( Site 1008); Recruiting

Phoenix, Arizona, United States, 85032

Contact: Study Coordinator 602-258-4951

University of Arizona ( Site 1006); Recruiting

Tucson, Arizona, United States, 85724-0001

Contact: Study Coordinator 520-626-8000

United States, California

Cedars Sinai Medical Center ( Site 1082); Recruiting

Los Angeles, California, United States, 90048

Contact: Study Coordinator 310-423-3713

University of California Irvine ( Site 1086); Recruiting

Orange, California, United States, 92868

Contact: Study Coordinator 949-824-6256

Jeffrey S.Sager MD Medical Corporation ( Site 1060); Recruiting

Santa Barbara, California, United States, 93105-5311

Contact: Study Coordinator 805-845-1500

Stanford University ( Site 1024); Active, not recruiting

Stanford, California, United States, 94305

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028); Recruiting

Torrance, California, United States, 90502

Contact: Study Coordinator 310-222-3560

United States, Colorado

University Of Colorado ( Site 1013); Recruiting

Aurora, Colorado, United States, 80045

Contact: Study Coordinator 720-848-2786

South Denver Cardiology Associates ( Site 1091); Recruiting

Littleton, Colorado, United States, 80120

Contact: Study Coordinator 303-715-2210

United States, Connecticut

Winchester Chest Clinic ( Site 1093); Recruiting

New Haven, Connecticut, United States, 06519-1304

Contact: Study Coordinator 203-688-1861

United States, District of Columbia

The George Washington University Medical Faculty Associates ( Site 1025); Recruiting

Washington, District of Columbia, United States, 20037-3201

Contact: Study Coordinator 202-741-3624

United States, Florida

Bay Area Cardiology ( Site 1071); Recruiting

Brandon, Florida, United States, 33511

Contact: Study Coordinator 813-684-6000

Mayo Clinic Jacksonville - PPDS ( Site 1045); Recruiting

Jacksonville, Florida, United States, 32224

Contact: Study Coordinator 904-953-2381

AdventHealth Orlando ( Site 1058); Recruiting

Orlando, Florida, United States, 32803

Contact: Study Coordinator 407-303-7556

Tampa General Hospital ( Site 1043); Recruiting

Tampa, Florida, United States, 33606

Contact: Study Coordinator 813-259-0826

United States, Georgia

Piedmont Atlanta Hospital ( Site 1085); Recruiting

Atlanta, Georgia, United States, 30309-1281

Contact: Study Coordinator 770-948-6041

Emory University ( Site 1030); Recruiting

Atlanta, Georgia, United States, 30322-1013

Contact: Study Coordinator 404-712-1370

United States, Idaho

Saint Alphonsus Regional Medical Center ( Site 1097); Recruiting

Boise, Idaho, United States, 83704-8880

Contact: Study Coordinator 208-367-7676

United States, Illinois

University of Illinois Hospital ( Site 1095); Recruiting

Chicago, Illinois, United States, 60612

Contact: Study Coordinator 312-355-5918

United States, Indiana

IU Health Advanced Heart and Lung Care ( Site 1092); Recruiting

Indianapolis, Indiana, United States, 46202-1218

Contact: Study Coordinator 317-962-9700

Ascension Medical Group St. Vincent ( Site 1076); Recruiting

Indianapolis, Indiana, United States, 46260

Contact: Study Coordinator 317-338-6666

United States, Iowa

University of Iowa Hospital and Clinics ( Site 1050); Recruiting

Iowa City, Iowa, United States, 52242

Contact: Study Coordinator 319-356-2577

United States, Kansas

University of Kansas Medical Center ( Site 1020); Recruiting

Kansas City, Kansas, United States, 66160

Contact: Study Coordinator 913-588-2314

United States, Kentucky

Norton Pulmonary Specialists ( Site 1066); Active, not recruiting

Louisville, Kentucky, United States, 40202

United States, Louisiana

University Medical Center New Orleans ( Site 1057); Recruiting

New Orleans, Louisiana, United States, 70112

Contact: Study Coordinator 504-903-7302

United States, Massachusetts

Tufts Medical Center - PPDS ( Site 1012); Recruiting

Boston, Massachusetts, United States, 02111

Contact: Study Coordinator 617-636-2892

Brigham and Women's Hospital [Boston, MA] ( Site 1014); Recruiting

Boston, Massachusetts, United States, 02215

Contact: Study Coordinator 617-525-1267

United States, Michigan

University of Michigan ( Site 1011); Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Study Coordinator 734-232-3741

United States, Minnesota

University of Minnesota Hospitals ( Site 1062); Completed

Minneapolis, Minnesota, United States, 55455

United States, Missouri

Washington University School of Medicine [Saint Louis, MO] ( Site 1022); Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Study Coordinator 314-747-8174

United States, Nebraska

University of Nebraska Medical Center ( Site 1053); Recruiting

Omaha, Nebraska, United States, 68198

Contact: Study Coordinator 402-559-7182

United States, New York

Pulmonary Health Physicians ( Site 1080); Recruiting

Liverpool, New York, United States, 13088

Contact: Study Coordinator 315-475-8402

Weill Cornell Medical College ( Site 1046); Recruiting

New York, New York, United States, 10021-9800

Contact: Study Coordinator 212-746-6645

University of Rochester Medical Center - PPDS ( Site 1039); Recruiting

Rochester, New York, United States, 14642

Contact: Study Coordinator 585-275-7434

United States, North Carolina

Duke University Medical Center ( Site 1026); Recruiting

Durham, North Carolina, United States, 27710-4000

Contact: Study Coordinator 919-668-2646

United States, Ohio

The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001); Recruiting

Cincinnati, Ohio, United States, 45219

Contact: Study Coordinator 515-585-1777

University Hospitals Cleveland Medical Center ( Site 1005); Recruiting

Cleveland, Ohio, United States, 44106

Contact: Study Coordinator 216-844-2878

Cleveland Clinic Foundation ( Site 1065); Recruiting

Cleveland, Ohio, United States, 44195

Contact: Study Coordinator 216-444-2200

University of Toledo Medical Center ( Site 1070); Completed

Toledo, Ohio, United States, 43614

United States, Oregon

Oregon Health Science University ( Site 1054); Recruiting

Portland, Oregon, United States, 97239-3098

Contact: Study Coordinator 503-494-8311

United States, Pennsylvania

Allegheny General Hospital ( Site 1088); Recruiting

Pittsburgh, Pennsylvania, United States, 15212-4737

Contact: Study Coordinator 412-359-8420

Lankenau Institute for Medical Research ( Site 1089); Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contact: Study Coordinator 610-645-2494

United States, Rhode Island

Rhode Island Hospital ( Site 1033); Recruiting

East Providence, Rhode Island, United States, 02915

Contact: Study Coordinator 401-444-0369

United States, South Carolina

Medical University of South Carolina - PPDS ( Site 1003); Recruiting

Charleston, South Carolina, United States, 29425-0001

Contact: Study Coordinator 843-792-3162

United States, Tennessee

Statcare Pulmonary Consultants - Knoxville ( Site 1031); Recruiting

Knoxville, Tennessee, United States, 37919

Contact: Study Coordinator 941-924-9800

United States, Utah

Intermountain Medical Center ( Site 1079); Recruiting

Murray, Utah, United States, 84107

Contact: Study Coordinator 801-507-3747

United States, Virginia

Inova Heart and Vascular Institute ( Site 1078); Recruiting

Falls Church, Virginia, United States, 22042

Contact: Study Coordinator 703-776-3610

Bon Secours St. Mary's Hospital ( Site 1069); Recruiting

Richmond, Virginia, United States, 23226

Contact: Study Coordinator 804-591-3533

United States, West Virginia

West Virginia University ( Site 1081); Active, not recruiting

Morgantown, West Virginia, United States, 26506

United States, Wisconsin

Aurora St Luke's Medical Center ( Site 1083); Recruiting

Milwaukee, Wisconsin, United States, 53215

Contact: Study Coordinator 414-649-3780

Froedtert Hospital & the Medical College of Wisconsin ( Site 1051); Recruiting

Milwaukee, Wisconsin, United States, 53226

Contact: Study Coordinator 414-955-0500

Belgium

Hôpital Erasme ( Site 1402); Recruiting

Anderlecht, Bruxelles-Capitale, Region De, Belgium, 1070

Contact: Study Coordinator +3225553111

UZ Leuven - Campus Gasthuisberg ( Site 1401); Recruiting

Leuven, Vlaams-Brabant, Belgium, 3000

Contact: Study Coordinator +3216341245

Canada, Alberta

University Of Alberta ( Site 2101); Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contact: Study Coordinator (780) 407-1586

Canada, Ontario

Hamilton General Hospital-Special Immunology Services Clinic ( Site 2110); Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contact: Study Coordinator (905) 524-2424

University Health Network c/o Toronto General Hospital ( Site 2109); Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contact: Study Coordinator 416-340-4043

Canada, Quebec

Institut Universitaire de Cardiologie et de Pneumologie ( Site 2107); Recruiting

Sainte Foy, Quebec, Canada, G1V 4G5

Contact: Study Coordinator 418-656-8711

France

Hôpital Pasteur - CHU Nice ( Site 1311); Recruiting

Nice, Alpes-Maritimes, France, 06000

Contact: Study Coordinator +33492038473

Centre Hospitalier Universitaire du Besancon ( Site 1324); Recruiting

Besançon, Doubs, France, 25000

Contact: Study Coordinator +33381668624

Hopital de Rangueil du Toulouse ( Site 1322); Recruiting

Toulouse, Haute-Garonne, France, 31400

Contact: Study Coordinator +33561323240

CHU Montpellier Hôpital Arnaud de VIlleneuve ( Site 1301); Recruiting

Montpellier, Herault, France, 34090

Contact: Study Coordinator +33 4 67 33 67 33

Hôpital Pontchaillou ( Site 1319); Recruiting

Rennes, Ille-et-Vilaine, France, 35033

Contact: Study Coordinator +33299282525

Centre Hospitalier Universitaire de Grenoble ( Site 1303); Recruiting

Grenoble cedex 09, Isere, France, 38043

Contact: Study Coordinator +33476765523

CHU de Nantes - Hoptal Nord Laennec ( Site 1309); Recruiting

Nantes, Loire-Atlantique, France, 44093

Contact: Study Coordinator +33240165023

CHU Angers ( Site 1313); Recruiting

Angers, Maine-et-Loire, France, 49933

Contact: Study Coordinator +33241353695

CHRU de Nancy Hopitaux de Brabois ( Site 1308); Recruiting

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500

Contact: Study Coordinator +33383154021

CHRU Lille ( Site 1306); Recruiting

Lille, Nord, France, 59037

Contact: Study Coordinator +33320446011

CHU de Rouen ( Site 1323); Recruiting

Rouen, Seine-Maritime, France, 76000

Contact: Study Coordinator 33232888207

Centre Hospitalier Universitaire de Bicetre ( Site 1304); Recruiting

Le Kremlin Bicêtre, Val-de-Marne, France, 94270

Contact: Study Coordinator +33145212121

Germany

Thoraxklinik-Heidelberg gGmbH ( Site 1509); Recruiting

Heidelberg, Baden-Wurttemberg, Germany, 69126

Contact: Study Coordinator +49 6221 3960

Krankenhaus Neuwittelsbach ( Site 1510); Recruiting

München, Bayern, Germany, 80639

Contact: Study Coordinator +49 89 13040

University Hospital Regensburg ( Site 1503); Recruiting

Regensburg, Bayern, Germany, 93053

Contact: Study Coordinator +49941944489

Kerckhoff-Klinik-Forschungs-GmbH ( Site 1514); Recruiting

Bad Nauheim, Hessen, Germany, 61231

Contact: Study Coordinator +4960329962135

Universitätsklinikum Gießen und Marburg GmbH ( Site 1512); Recruiting

Gießen, Hessen, Germany, 35392

Contact: Study Coordinator +496419945113

Medizinische Hochschule Hannover ( Site 1505); Recruiting

Hannover, Niedersachsen, Germany, 30625

Contact: Study Coordinator +495115329184

Uniklinik Köln ( Site 1511); Recruiting

Cologne, Nordrhein-Westfalen, Germany, 50931

Contact: Study Coordinator +492214785860

Universitaetsmedizin Johannes Gutenberg Universitaet Mainz ( Site 1515); Recruiting

Mainz, Rheinland-Pfalz, Germany, 55131

Contact: Study Coordinator +496131170

Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501); Recruiting

Dresden, Sachsen, Germany, 01307

Contact: Study Coordinator +493514585089

DRK Kliniken Berlin Westend ( Site 1507); Recruiting

Berlin, Germany, 14050

Contact: Study Coordinator +49 3030354305

Israel

Assuta Ashdod Medical Center ( Site 1710); Recruiting

Ashdod, Israel, 7747629

Contact: Study Coordinator 972532227937

Shamir Medical Center Assaf Harofeh ( Site 1713); Recruiting

Be'er Ya'akov, Israel, 7030001

Contact: Study Coordinator +97289779999

Rambam Health Corp. ( Site 1716); Recruiting

Haifa, Israel, 3109601

Contact: Study Coordinator +97248542181

Lady Davis Carmel Medical Center ( Site 1705); Recruiting

Haifa, Israel, 3436212

Contact: Study Coordinator +97248342707

Edith Wolfson Medical Center ( Site 1717); Recruiting

Holon, Israel, 58100

Contact: Study Coordinator +97235011991

Shaare Zedek Medical Center ( Site 1715); Recruiting

Jerusalem, Israel, 91031

Contact: Study Coordinator 972508685209

Hadassah Ein Kerem Medical Center ( Site 1711); Recruiting

Jerusalem, Israel, 9574425

Contact: Study Coordinator +97226777595

Rabin Medical Center ( Site 1703); Recruiting

Petah Tiqwa, Israel, 4941492

Contact: Study Coordinator +97239376751

Kaplan Medical Center ( Site 1712); Recruiting

Rehovot, Israel, 7610001

Contact: Study Coordinator +97289440040

ZIV Medical Center ( Site 1704); Recruiting

Safed, Israel, 13100

Contact: Study Coordinator +97246828943

Tel Aviv Sourasky Medical Center ( Site 1714); Recruiting

Tel Aviv, Israel, 64239

Contact: Study Coordinator +97236973776

Italy

AOU di Bologna Policlinico S Orsola Malpighi ( Site 2409); Recruiting

Bologna, Emilia-Romagna, Italy, 40138

Contact: Study Coordinator +39051453104

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405); Recruiting

Trieste, Friuli-Venezia Giulia, Italy, 34149

Contact: Study Coordinator 39 040 399 1111

Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406); Recruiting

Monza, Lombardia, Italy, 20900

Contact: Study Coordinator +3903923311

Fondazione IRCCS-Policlinico San Matteo ( Site 2401); Recruiting

Pavia, Lombardia, Italy, 27100

Contact: Study Coordinator +390382503777

Ospedale SS Annunziata ( Site 2408); Recruiting

Sassari, Sardegna, Italy, 07100

Contact: Study Coordinator 079 2061531939

ASST Papa Giovanni XXIII ( Site 2410); Recruiting

Bergamo, Italy, 24127

Contact: Study Coordinator +390352675027

Azienda Policlinico Umberto I ( Site 2402); Recruiting

Roma, Italy, 00161

Contact: Study Coordinator +390649970382

Poland

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 2806); Recruiting

Lubin, Lubelskie, Poland, 20-718

Contact: Study Coordinator +48815374556

Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2801); Recruiting

Krakow, Malopolskie, Poland, 31-202

Contact: Study Coordinator +48126143501

Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802); Recruiting

Otwock, Mazowieckie, Poland, 05-400

Contact: Study Coordinator +48227103010

Państwowy Instytut Medyczny MSWiA ( Site 2805); Recruiting

Warszawa, Mazowieckie, Poland, 02-507

Contact: Study Coordinator +0048502133158

Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie ( Site 2804); Recruiting

Szczecin, Zachodniopomorskie, Poland, 70-111

Contact: Study Coordinator +48914661197

Spain

Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604); Recruiting

Majadahonda, Madrid, Spain, 28222

Contact: Study Coordinator +34911917418

Hospital Clinic de Barcelona ( Site 1602); Recruiting

Barcelona, Spain, 08036

Contact: Study Coordinator +34932275786

Hospital Universitario 12 de Octubre ( Site 1603); Recruiting

Madrid, Spain, 28041

Contact: Study Coordinator +34914692313

Hospital Universitario Virgen Macarena ( Site 1612); Recruiting

Sevilla, Spain, 41009

Contact: Study Coordinator +34600162109

Hospital Universitario de Toledo ( Site 1607); Recruiting

Toledo, Spain, 41007

Contact: Study Coordinator +34600162109

Sweden

Sahlgrenska Universitetssjukhuset ( Site 3201); Recruiting

Goteburg, Vastra Gotalands Lan, Sweden, 413 45

Contact: Study Coordinator +46313422929

United Kingdom

Imperial College Healthcare NHS Trust ( Site 1203); Recruiting

London, London, City Of, United Kingdom, W12 0HS

Contact: Study Coordinator 020 3311 3311

Sponsors and Collaborators

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

More Information

Additional Information:

Merck Clinical Trials Information 

• Responsible Party: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
• ClinicalTrials.gov Identifier: NCT04945460
• Other Study ID Numbers: 7962-007; A011-16 ( Other Identifier: Acceleronpharma ); MK-7962-007 ( Other Identifier: Merck ); 2021-003020-32 ( EudraCT Number )
• First Posted: June 30, 2021
• Last Update Posted: April 26, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA:

Pulmonary, hypertension, Cpc PH, HFpEF, sotatercept

Additional relevant MeSH terms:

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