Hypertension, PulmonaryPhase 2HARMONIZENCT06814145
Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
A Phase 2 study testing Sotatercept in people with Hypertension, Pulmonary, run by Merck Sharp & Dohme LLC at 57 sites in 12 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Sotatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 57 sitesin 12 countries
- Study dates
- 16 Apr 2025to 10 Aug 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Completed sotatercept parent study (MK-7962-007[CADENCE] [Visit 9 and EOT visit] or MK-7962-041 [P041] [EOT Visit]) without discontinuing study intervention and is able to safely enroll into MK-7962-023 (HARMONIZE)
Who cannot join
- 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 and has an ongoing SAE that occurred during parent study and is suspected to be related to study intervention
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
57 sites in 12 countries.
57 sites in 12 countries
United States23 sites
The Emory Clinic ( Site 1030)
Atlanta, Georgia, 30322
Medical University of South Carolina ( Site 1003)
Charleston, South Carolina, 29425
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, 45219
The Cleveland Clinic Foundation. ( Site 1065)
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio, 43210
Duke University Medical Center ( Site 1026)
Durham, North Carolina, 27710-4000
Inova Fairfax Medical Campus ( Site 1078)
Falls Church, Virginia, 22042
Statcare Pulmonary Consultants ( Site 1031)
Knoxville, Tennessee, 37919
Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004)
La Jolla, California, 92037
South Denver Cardiology Associates ( Site 1091)
Littleton, Colorado, 80120
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, 40202
Intermountain Medical Center ( Site 1079)
Murray, Utah, 84107
Yale New Haven Hospital ( Site 1093)
New Haven, Connecticut, 06520
Weill Cornell Medical Center ( Site 1046)
New York, New York, 10065
University Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, 68198
AdventHealth Orlando ( Site 1058)
Orlando, Florida, 32803
Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, 85032
Allegheny General Hospital ( Site 1088)
Pittsburgh, Pennsylvania, 15212-4737
Rhode Island Hospital ( Site 1039)
Providence, Rhode Island, 02903
Pulmonary Associates of Richmond - West Broad Street ( Site 1069)
Richmond, Virginia, 23230
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California, 93105
Stanford University Medical Center ( Site 1024)
Stanford, California, 94305
Lankenau Medical Center ( Site 1089)
Wynnewood, Pennsylvania, 19096
Germany7 sites
DRK Kliniken Berlin Westend ( Site 0307)
Berlin, 14050
Universitaetsklinikum Koeln ( Site 0311)
Cologne, North Rhine-Westphalia, 50937
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)
Dresden, Saxony, 01307
UKGM Gießen/Marburg ( Site 0312)
Giessen, Hesse, 35392
Thoraxklinik-Heidelberg gGmbH ( Site 0309)
Heidelberg, Baden-Wurttemberg, 69126
Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)
Mainz, Rhineland-Palatinate, 55131
Krankenhaus Neuwittelsbach ( Site 0310)
München, Bavaria, 80639
France6 sites
Centre Hopitalier Universitaire d'Angers ( Site 0204)
Angers, Maine-et-Loire, 49100
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)
Le Kremlin-Bicêtre, Val-de-Marne, 94270
Hopital Arnaud de Villeneuve ( Site 0200)
Montpellier, Herault, 34295
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)
Nice, Alpes-Maritimes, 06000
CHU de Rouen ( Site 0203)
Rouen, Seine-Maritime, 76031
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)
Saint-Herblain, Loire-Atlantique, 44800
Israel5 sites
Rambam Health Care Campus ( Site 0403)
Haifa, 3109601
Edith Wolfson Medical Center ( Site 0404)
Holon, 5810001
Hadassah Medical Center ( Site 0402)
Jerusalem, 9112001
Meir Medical Center ( Site 0401)
Kfar Saba, 4428164
ZIV Medical Center ( Site 0400)
Safed, 1311001
Spain5 sites
Hospital Clinic I Provincial de Barcelona ( Site 0701)
Barcelona, 08036
Hospital Universitario 12 de Octubre ( Site 0702)
Madrid, 28041
Hospital Costa del Sol ( Site 0704)
Marbella, Malaga, 29603
Hospital Universitario Virgen Macarena ( Site 0705)
Seville, 41009
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)
Toledo, 45007
Italy3 sites
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)
Bergamo, Lombardy, 24127
Fondazione IRCCS Policlinico San Matteo ( Site 0501)
Pavia, 27100
AOU Policlinico Umberto I ( Site 0500)
Roma, 00161
Poland3 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)
Bialystok, Podlaskie Voivodeship, 15-276
Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddzial Kliniczny Chorob Serca i Naczyn z Podod ( Site 0600)
Krakow, Lesser Poland Voivodeship, 31-202
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)
Lublin, Lublin Voivodeship, 20-718
Belgium1 site
Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)
Brussels, Bruxelles-Capitale, Region de, 1070
Canada1 site
Hamilton Health Sciences Hamilton General Hospital ( Site 0004)
Hamilton, Ontario, L8L 2X2
Mexico1 site
Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)
Monterrey, Nuevo León, 64718
Sweden1 site
Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)
Gothenburg, Västra Götaland County, 413 46
United Kingdom1 site
Hammersmith Hospital-Department of Cardiology ( Site 0900)
London, London, City of, W12 OHS
About this study
Official title: A Phase 2, Multicenter, Open-label Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) With Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
Read the detailed description
This is an extension study for studies MK-7962-007 (NCT04945460) and MK-7962-041 (NCT number pending).
Following protocol amendment 3, all participants in the Sotatercept 0.7 mg/kg arm will switch to the Sotatercept 0.3 mg/kg arm, and new participants will only enroll in the Sotatercept 0.3 mg/kg arm.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Sotatercept
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptBiological
Also called ACE-011
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept 0.3 mg/kg | Experimental | Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 10 years or until discontinuation. Receives: Biological: Sotatercept |
| Sotatercept 0.7 mg/kg | Experimental | Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 10 years or until discontinuation. Receives: Biological: Sotatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 10 years
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 10 years
Secondary outcomes (22)
Change From Parent Study Baseline in Pulmonary Vascular Resistance (PVR) at 6 Months Following Enrollment in the Extension
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from baseline in PVR at Month 6 will be presented. Per protocol, baseline was defined as the baseline data collected for each participant at the time of their enrollment on one of the parent studies.
Measured: Baseline and Month 6
Change From Baseline in the 6-Minute Walk Distance (6MWD) at 6 Months Following Enrollment in the Extension
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and Month 6
Change From Baseline in the 6MWD at 12 Months Following Enrollment in the Extension
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and Month 12
Change From Baseline in the 6MWD at 18 Months Following Enrollment in the Extension
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and Month 18
Change From Baseline in the 6MWD at End of Treatment
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and up to approximately 43.5 months
Change From Baseline in New York Heart Association Functional Class (NYHA FC) at 6 Months Following Enrollment in the Extension
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and Month 6
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and Month 12
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and Month 18
Change From Baseline in NYHA FC at End of Treatment
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and up to approximately 10 years
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at 6 Months Following Enrollment in the Extension
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and Month 6
Change From Baseline in NT-proBNP at 12 Months Following Enrollment in the Extension
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and Month 12
Change From Baseline in NT-proBNP at 18 Months Following Enrollment in the Extension
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and Month 18
Change From Baseline in NT-proBNP at End of Treatment
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Measured: Baseline and up to approximately 10 years
Change From Parent Study Week 24 in PVR at 6 Months Following Enrollment in the Extension for Placebo Participants
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from parent study Week 24 in PVR at Month 6 will be presented. Per protocol, baseline was defined as the value collected at Week 24 of the parent study.
Measured: Baseline and Month 6
Change From Baseline in 6MWD at 6 Months Following Enrollment in the Extension for Placebo Participants
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 6 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Measured: Baseline and Month 6
Change From Baseline in 6MWD at 12 Months Following Enrollment in the Extension for Placebo Participants
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 12 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Measured: Baseline and Month 12
Change From Baseline in 6MWD at 18 Months Following Enrollment in the Extension for Placebo Participants
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 18 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Measured: Baseline and Month 18
Change From Baseline in 6MWD at End of Treatment for Placebo Participants
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at the time of treatment discontinuation will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Measured: Baseline and up to approximately 43.5 months
Change From Baseline in NYHA FC at 6 Months Following Enrollment in the Extension for Placebo Participants
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 6 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Measured: Baseline and Month 6
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension for Placebo Participants
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 12 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Measured: Baseline and Month 12
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension for Placebo Participants
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 18 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Measured: Baseline and Month 18
Change From Baseline in NYHA FC at End of Treatment for Placebo Participants
NYHA FC classifies the extent of heart failure. The change from extension baseline in NYHA FC at the time of treatment discontinuation will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Measured: Baseline and up to approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start16 Apr 2025
- Primary completion10 Aug 2035 (estimated)
- Study completion10 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814145
- Sponsor's protocol ID
- 7962-023
- Other IDs
- MK-7962-023, U1111-1309-2142, 2024-515773-99-00
- Acronym
- HARMONIZE
- Status last verified
- Jul 2026
- First submitted
- 3 Feb 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) With Heart Failure With Preserved Ejection Fraction (HFpEF)
- ClinicalTrials.gov ID
- NCT06814145
- Acronym / sponsor ID
- HARMONIZE / 7962-023
- Conditions
- Hypertension, Pulmonary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 10 Aug 2035 (estimated)
- Study completion
- 10 Aug 2035 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an extension study for studies MK-7962-007 (NCT04945460) and MK-7962-041 (NCT number pending).
Following protocol amendment 3, all participants in the Sotatercept 0.7 mg/kg arm will switch to the Sotatercept 0.3 mg/kg arm, and new participants will only enroll in the Sotatercept 0.3 mg/kg arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotatercept 0.3 mg/kg | Experimental | Biological: SotaterceptParticipants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 10 years or until discontinuation. |
| Sotatercept 0.7 mg/kg | Experimental | Biological: SotaterceptParticipants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 10 years or until discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completed sotatercept parent study (MK-7962-007[CADENCE] [Visit 9 and EOT visit] or MK-7962-041 [P041] [EOT Visit]) without discontinuing study intervention and is able to safely enroll into MK-7962-023 (HARMONIZE)
Key exclusion criteria (9 listed)
- 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 and has an ongoing SAE that occurred during parent study and is suspected to be related to study intervention
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotaterceptAlso: ACE-011subcutaneous injection | Biological | Sotatercept 0.3 mg/kg, Sotatercept 0.7 mg/kg |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 10 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 10 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
22 secondary outcomes
Change From Parent Study Baseline in Pulmonary Vascular Resistance (PVR) at 6 Months Following Enrollment in the Extension
Time frame: Baseline and Month 6
Change From Baseline in the 6-Minute Walk Distance (6MWD) at 6 Months Following Enrollment in the Extension
Time frame: Baseline and Month 6
Change From Baseline in the 6MWD at 12 Months Following Enrollment in the Extension
Time frame: Baseline and Month 12
Change From Baseline in the 6MWD at 18 Months Following Enrollment in the Extension
Time frame: Baseline and Month 18
Change From Baseline in the 6MWD at End of Treatment
Time frame: Baseline and up to approximately 43.5 months
Change From Baseline in New York Heart Association Functional Class (NYHA FC) at 6 Months Following Enrollment in the Extension
Time frame: Baseline and Month 6
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension
Time frame: Baseline and Month 12
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension
Time frame: Baseline and Month 18
Change From Baseline in NYHA FC at End of Treatment
Time frame: Baseline and up to approximately 10 years
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at 6 Months Following Enrollment in the Extension
Time frame: Baseline and Month 6
Change From Baseline in NT-proBNP at 12 Months Following Enrollment in the Extension
Time frame: Baseline and Month 12
Change From Baseline in NT-proBNP at 18 Months Following Enrollment in the Extension
Time frame: Baseline and Month 18
Change From Baseline in NT-proBNP at End of Treatment
Time frame: Baseline and up to approximately 10 years
Change From Parent Study Week 24 in PVR at 6 Months Following Enrollment in the Extension for Placebo Participants
Time frame: Baseline and Month 6
Change From Baseline in 6MWD at 6 Months Following Enrollment in the Extension for Placebo Participants
Time frame: Baseline and Month 6
Change From Baseline in 6MWD at 12 Months Following Enrollment in the Extension for Placebo Participants
Time frame: Baseline and Month 12
Change From Baseline in 6MWD at 18 Months Following Enrollment in the Extension for Placebo Participants
Time frame: Baseline and Month 18
Change From Baseline in 6MWD at End of Treatment for Placebo Participants
Time frame: Baseline and up to approximately 43.5 months
Change From Baseline in NYHA FC at 6 Months Following Enrollment in the Extension for Placebo Participants
Time frame: Baseline and Month 6
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension for Placebo Participants
Time frame: Baseline and Month 12
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension for Placebo Participants
Time frame: Baseline and Month 18
Change From Baseline in NYHA FC at End of Treatment for Placebo Participants
Time frame: Baseline and up to approximately 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Plain Language SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
57 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sotatercept in people with Hypertension, Pulmonary, run by Merck Sharp & Dohme LLC at 57 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Germany, France, Israel, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.