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NCT Number: NCT06814145

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Université Libre de Bruxelles - Hôpital Erasme ( Site 0100), Brussels, Bruxelles-Capitale, Region de, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

  • 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
  • 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

Treatment and study plan

Sotatercept

Biological

subcutaneous injection

Other names: ACE-011

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change From Parent Study Baseline in Pulmonary Vascular Resistance (PVR) at 6 Months Following Enrollment in the Extension

    Time frame: Baseline and Month 6

    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.

  2. Change From Baseline in the 6-Minute Walk Distance (6MWD) at 6 Months Following Enrollment in the Extension

    Time frame: Baseline and Month 6

    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.

  3. Change From Baseline in the 6MWD at 12 Months Following Enrollment in the Extension

    Time frame: Baseline and Month 12

    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.

  4. Change From Baseline in the 6MWD at 18 Months Following Enrollment in the Extension

    Time frame: Baseline and Month 18

    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.

  5. Change From Baseline in the 6MWD at End of Treatment

    Time frame: Baseline and up to approximately 43.5 months

    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.

  6. 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

    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.

  7. Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension

    Time frame: Baseline and Month 12

    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.

  8. Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension

    Time frame: Baseline and Month 18

    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.

  9. Change From Baseline in NYHA FC at End of Treatment

    Time frame: Baseline and up to approximately 10 years

    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.

  10. 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

    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.

  11. Change From Baseline in NT-proBNP at 12 Months Following Enrollment in the Extension

    Time frame: Baseline and Month 12

    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.

  12. Change From Baseline in NT-proBNP at 18 Months Following Enrollment in the Extension

    Time frame: Baseline and Month 18

    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.

  13. Change From Baseline in NT-proBNP at End of Treatment

    Time frame: Baseline and up to approximately 10 years

    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.

  14. 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

    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.

  15. Change From Baseline in 6MWD at 6 Months Following Enrollment in the Extension for Placebo Participants

    Time frame: Baseline and Month 6

    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.

  16. Change From Baseline in 6MWD at 12 Months Following Enrollment in the Extension for Placebo Participants

    Time frame: Baseline and Month 12

    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.

  17. Change From Baseline in 6MWD at 18 Months Following Enrollment in the Extension for Placebo Participants

    Time frame: Baseline and Month 18

    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.

  18. Change From Baseline in 6MWD at End of Treatment for Placebo Participants

    Time frame: Baseline and up to approximately 43.5 months

    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.

  19. Change From Baseline in NYHA FC at 6 Months Following Enrollment in the Extension for Placebo Participants

    Time frame: Baseline and Month 6

    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.

  20. Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension for Placebo Participants

    Time frame: Baseline and Month 12

    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.

  21. Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension for Placebo Participants

    Time frame: Baseline and Month 18

    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.

  22. Change From Baseline in NYHA FC at End of Treatment for Placebo Participants

    Time frame: Baseline and up to approximately 10 years

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Acronym: HARMONIZE

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Feb 7, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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