TX000045 for Pulmonary Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TX000045 (also known as TX45 or Fc-relaxin fusion protein) for individuals with pulmonary hypertension (high blood pressure in the lungs) who also have heart failure. Researchers aim to assess how two different doses of the treatment affect symptoms over 24 weeks. Participants are divided into three groups: one receiving Dose A, another receiving Dose B plus a placebo, and a third receiving only a placebo. Suitable candidates for the trial have pulmonary hypertension with heart failure symptoms, such as shortness of breath, and have not been hospitalized or on certain medications recently. Participants should also be stable on their current heart medications. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that your current heart failure or cardiovascular medications be at a stable dose before you start. It doesn't specify if you need to stop other medications, so it's best to discuss with the trial team.
Is there any evidence suggesting that TX000045 is likely to be safe for humans?
Research has shown that TX000045 is generally well-tolerated in human studies. In earlier research with healthy volunteers, most side effects were mild to moderate, and serious side effects were uncommon. Additionally, when administered as a single dose through an IV, TX000045 was well-tolerated, with few experiencing severe or harmful effects. These findings offer reassurance about the safety of TX000045 for those considering joining a clinical trial.12345
Why are researchers excited about this study treatment for pulmonary hypertension?
Researchers are excited about TX000045 because it offers a novel approach to treating pulmonary hypertension. Unlike most standard treatments that primarily dilate blood vessels to reduce pressure, TX000045 might work through a new mechanism, potentially addressing the root causes of the condition more effectively. Additionally, TX000045 is administered subcutaneously every two weeks, which could be more convenient than some current options that require more frequent dosing or invasive administration. This could mean a more manageable treatment routine and potentially better outcomes for patients.
What evidence suggests that TX000045 might be an effective treatment for pulmonary hypertension?
Research has shown that TX000045 may help treat pulmonary hypertension. In earlier studies, TX000045 reduced lung pressure by 19%, aiding breathing and easing the heart's workload. It also improved heart function and blood flow in patients with pulmonary hypertension related to heart failure. Most participants tolerated the treatment well, experiencing no serious side effects. In this trial, participants will receive either TX000045 Dose A, TX000045 Dose B, or a placebo. These findings suggest that TX000045 could effectively treat pulmonary hypertension.16789
Who Is on the Research Team?
Robert Rogers, MD
Principal Investigator
Tectonic Therapeutic
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with pulmonary hypertension secondary to heart failure who can walk a certain distance and have stable heart medication. They must not be pregnant, planning intense new exercise, or have recent drug abuse history or hospitalization.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either TX000045 or placebo subcutaneously every 2 weeks for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TX000045
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tectonic Therapeutic
Lead Sponsor