In short
Clinical trials are investigating TX000045 in people with pulmonary hypertension secondary to heart failure with preserved ejection fraction (PH-HFpEF). The main aim is to see whether TX000045 can improve blood flow resistance in the lungs and to assess safety. The study includes adults with PH-HFpEF and a baseline pulmonary vascular resistance of at least 3 Wood units.
Key points
- TX000045 is being studied in a Phase 2 clinical trial for people with pulmonary hypertension secondary to heart failure with preserved ejection fraction, also called PH-HFpEF. The study is planned for 255 participants and lasts 24 weeks. Researchers want to see whether TX000045 can improve pulmonary vascular resistance, a measure of resistance in the lung blood vessels. The trial also tracks safety, including adverse events, serious adverse events, lab changes, ECG results, vital signs, and physical exam findings. Participants must have a baseline pulmonary vascular resistance of at least 3 Wood units. The trial is authorised.
Trial overview
The available study of TX000045 is called the APEX Study and is designed for people with pulmonary hypertension secondary to heart failure with preserved ejection fraction (PH-HFpEF). It is an interventional trial, which means researchers assign a study treatment and compare outcomes between groups. The study is in Phase 2 and is authorised.
Who can participate
The trial is for participants with pulmonary hypertension linked to HFpEF. A key entry requirement is a baseline pulmonary vascular resistance (PVR) of at least 3 Wood units, which means the lung blood vessels must show a certain level of resistance at the start of the study. The trial data do not list other eligibility details, so only this condition-based requirement can be confirmed here.
What the study measures
The main endpoint is the mean change from baseline to Week 24 in PVR, measured by right heart catheterization (RHC), in participants with baseline PVR of at least 3 Wood units who receive TX000045 compared with those who receive placebo. This tells researchers whether TX000045 changes how much resistance blood meets in the lung circulation over time.
The study also measures safety outcomes, including the number of adverse events, adverse events of special interest, and serious adverse events in people who receive TX000045 compared with placebo. In addition, researchers are watching for clinically significant changes in laboratory tests, 12-lead electrocardiogram (ECG), vital signs, and physical examinations.
Study design and treatment groups
The study compares TX000045 with a sterile isotonic solution, which is the placebo used in this trial. The listed TX000045 dose is 300 mg given by subcutaneous administration, meaning under the skin. The brief summary says the study is evaluating the effect of TX000045 versus placebo on mean PVR and also assessing safety in PH-HFpEF.
Study status and size
The trial has an enrollment target of 255 participants. Its current status is authorised. The study duration is 24 weeks, and the main outcome is assessed at Week 24.