A Phase 2 interventional study of Sotatercept in Hypertension, Pulmonary, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 57 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
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.
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's planned enrollment of 440 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 10 years or until discontinuation.
Biological: Sotatercept
Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 10 years or until discontinuation.
Biological: Sotatercept
subcutaneous injection
Also known as: ACE-011
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.
Time frame: 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.
Time frame: Up to approximately 10 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and up to approximately 10 years
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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