Sotatercept for Pulmonary Hypertension
(HARMONIZE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Sotatercept for treating pulmonary hypertension?
Research shows that adding Sotatercept to existing treatments for pulmonary arterial hypertension (a type of high blood pressure affecting the lungs) improved patients' ability to walk further in six minutes after 24 weeks. Additionally, it significantly reduced the resistance in blood vessels in the lungs, indicating better blood flow.12345
How is the drug sotatercept different from other treatments for pulmonary hypertension?
Sotatercept is unique because it is a fusion protein that works by trapping activins and growth differentiation factors, aiming to restore balance in signaling pathways involved in pulmonary arterial hypertension. This mechanism is different from other treatments, which typically focus on dilating blood vessels or reducing blood pressure.12345
What is the purpose of this trial?
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.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
This trial is for people with a specific kind of pulmonary hypertension called Cpc-PH, which results from heart failure with preserved ejection fraction (HFpEF). Only those who completed the CADENCE study without stopping the treatment and can safely join the HARMONIZE extension are eligible.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sotatercept 0.3 mg/kg or 0.7 mg/kg subcutaneous injection every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive sotatercept to evaluate long-term safety and tolerability
Treatment Details
Interventions
- Sotatercept
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University