Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
- 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). 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.
- Acronym
- HARMONIZE
- Short title
- Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
- 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)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2035-08-10
- First posted
- 2025-02-07
- Registry last updated
- 2026-07-22
- Primary completion date
- 2035-08-10
- Start date
- 2025-04-16
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06814145
- ClinicalTrials.gov ID
- NCT06814145
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Number of Participants Who Experience an Adverse Event (AE)
Timeframe: 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
Timeframe: 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.
Change From Parent Study Baseline in Pulmonary Vascular Resistance (PVR) at 6 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in the 6-Minute Walk Distance (6MWD) at 6 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in the 6MWD at 12 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in the 6MWD at 18 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in the 6MWD at End of Treatment
Timeframe: 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.
Change From Baseline in New York Heart Association Functional Class (NYHA FC) at 6 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in NYHA FC at End of Treatment
Timeframe: 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.
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at 6 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in NT-proBNP at 12 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in NT-proBNP at 18 Months Following Enrollment in the Extension
Timeframe: 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.
Change From Baseline in NT-proBNP at End of Treatment
Timeframe: 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.
Change From Parent Study Week 24 in PVR at 6 Months Following Enrollment in the Extension for Placebo Participants
Timeframe: 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.
Change From Baseline in 6MWD at 6 Months Following Enrollment in the Extension for Placebo Participants
Timeframe: 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.
Change From Baseline in 6MWD at 12 Months Following Enrollment in the Extension for Placebo Participants
Timeframe: 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.
Change From Baseline in 6MWD at 18 Months Following Enrollment in the Extension for Placebo Participants
Timeframe: 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.
Change From Baseline in 6MWD at End of Treatment for Placebo Participants
Timeframe: 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.
Change From Baseline in NYHA FC at 6 Months Following Enrollment in the Extension for Placebo Participants
Timeframe: 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.
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension for Placebo Participants
Timeframe: 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.
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension for Placebo Participants
Timeframe: 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.
Change From Baseline in NYHA FC at End of Treatment for Placebo Participants
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
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)
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
- Pulmonary Associates, PA ( Site 1008)Phoenix, United States
- Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004)La Jolla, United States
- Jeffrey S. Sager, MD Medical Corporation ( Site 1060)Santa Barbara, United States
- Stanford University Medical Center ( Site 1024)Stanford, United States
- South Denver Cardiology Associates ( Site 1091)Littleton, United States
- Yale New Haven Hospital ( Site 1093)New Haven, United States
- AdventHealth Orlando ( Site 1058)Orlando, United States
- The Emory Clinic ( Site 1030)Atlanta, United States
- Norton Pulmonary Specialists ( Site 1066)Louisville, United States
- University Of Nebraska Medical Center ( Site 1053)Omaha, United States
- Weill Cornell Medical Center ( Site 1046)New York, United States
- Duke University Medical Center ( Site 1026)Durham, United States
- The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)Cincinnati, United States
- The Cleveland Clinic Foundation. ( Site 1065)Cleveland, United States
- The Ohio State University Wexner Medical Center ( Site 1032)Columbus, United States
- Allegheny General Hospital ( Site 1088)Pittsburgh, United States
- Lankenau Medical Center ( Site 1089)Wynnewood, United States
- Rhode Island Hospital ( Site 1039)Providence, United States
- Medical University of South Carolina ( Site 1003)Charleston, United States
- Statcare Pulmonary Consultants ( Site 1031)Knoxville, United States
- Intermountain Medical Center ( Site 1079)Murray, United States
- Inova Fairfax Medical Campus ( Site 1078)Falls Church, United States
- Pulmonary Associates of Richmond - West Broad Street ( Site 1069)Richmond, United States
- Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)Brussels, Belgium
- Hamilton Health Sciences Hamilton General Hospital ( Site 0004)Hamilton, Canada
And 32 more, listed on the interactive page.
- Related resource (www.merckclinicaltrials.com)
- MK-7962-023
- U1111-1309-2142
- 2024-515773-99-00
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Pulmonary hypertension Primary condition