A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
← catalyst calendarNCT06616974 · readout in 97 d
Sponsored by Tectonic Therapeutic (industry) · TECX — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
191estimated
Sites
72
Countries
Armenia, Australia, Austria +14
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-09-04 | actual | When the study began enrolling |
| Primary completion | 2026-11-24 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-05 | estimated | The whole study's end, after follow-up |
| First posted | 2024-09-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pulmonary Hypertension
- Heart Failure With Preserved Ejection Fraction
Interventions
- Drug: TX000045- Dose A
- Drug: TX000045- Dose B
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFMean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).
measured Baseline up to Week 24 post first dose
Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.
measured Baseline up to Week 30 post first dose
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
measured Baseline up to Week 30 post first dose
Number of participants with treatment-related adverse events.
measured Baseline up to Week 30 post first dose
Number of participants with changes in the physical examination findings.
measured Baseline to Week 30 post first dose
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